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THE MEDICAL DEVICES SAFETY BILL, 2008

No XX of 2008

No Name Clauses

Chapter 1 PRELIMINARY

AA Short title, extent and commencement Clauses 1-4

AB Preamble Clauses 5-9

AC Declaration as to the expediency of control by the Union Clauses 10-11

AD Definitions Clause 12

Chapter 2 INDIAN MEDICAL DEVICE AUTHORITY

AE Establishment of IMDA Clauses 13-16

AF Composition of�� the Governing Body of IMDA and appointment

of Chairperson, CEO and Members

Clauses 17-19

AG Committee for the selection of CEO of IMDA Clauses 20-25

AH Term of office of Members of Governing Body Clauses 26-32

AI Removal of Chairperson and Members of Governing Body Clauses 33-34

AJ Objects and Functions of IMDA Clauses 35-38

AK Proceedings of IMDA Clauses 39-42

AL Staff of IMDA Clauses 43-45

AM Functions of CEO Clauses 46-50

AN Advisory Committee Clause 51

AO Functions of Advisory Committee Clauses 52-54

AP Technical Panels Clauses 55-63

AQ Procedure for advisory committee and Technical Panels Clauses 64-65

AR Industry and Public Consultation Clauses 66-70

AS Review of IMDA Clauses 71-72

Chapter 3 ESSENTIAL PRINCIPLES OF MEDICAL DEVICE SAFETY AND PERFORMANCE

AT Essential Principles of Medical device safety and performance Clauses 73-76

Chapter 4 CLASSIFICATION OF MEDICAL DEVICES

AU General principles of Risk based classification of Medical

Devices

Clauses 77-82

Chapter 5 MEDICAL DEVICE STANDRADS

AV Selection and application of medical device standards Clauses 83-91

Chapter 6 CONFORMITY ASSESSMENT AND PLACING MEDICAL DEVICES ON THE

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MARKET BY THE MANUFACTURER

AW Responsibilities of the manufacturer Clauses 92-96

AX Technical documentation demonstrating conformity / STED Clauses 97-103

AY

System for post-market surveillance and adverse event

reporting Clauses 104 -106

AZ Declaration of conformity by Manufacturer Clauses 107 – 110

BA Registration, Marking and placing the device on the market. Clauses 111 - 118

BB Time limits for completion of Registration by IMDA Clauses 119 – 123

BC

Records of manufacture and tracking of devices; code of

advertising Clauses 124 – 125

BD

Obligations of manufacturers to allow inspection of their

premises Clauses 126

Chapter 7 CONFORMITY ASSESSMENT PROCEDURES, DEVICE MARKING AND

NOTIFIED BODIES

BE Conformity assessment procedures Clauses 127-140

BF Clinical investigation Clauses 141-145

BG

Conformity assessment certificates; entry, inspection and

taking of samples, etc. Clauses 146 – 147

BH Marking of Conforming medical devices Clauses 148-150

BI Notified Body Clauses 151-161

BJ Records of Notified Bodies Clause 162

BK Offences of Notified Bodies Clause 163

Chapter 8 EXPORT OF MEDICAL DEVICES FROM INDIA

BL Export of medical devices Clauses 164 – 167

Chapter 9 REFURBUISHED AND DATE EXPIRED MEDICAL DEVICES

BM Conditions governing use of refurbished/ date expired medical

devices

Clauses 168-169

Chapter 10 VIGILANCE AND REPORTING OF ADVERSE EVENTS

BN Vigilance by IMDA on adverse events and unsafe devices Clause 170 – 177

BO Vigilance on advertising and sales promotion Clauses 178-179

Chapter 11 ENFORCEMENT OF THIS ACT

BP Enforcement of this Act Clauses 180- 182

BQ Samples for testing Clauses 183- 185

BR Medical Device Laboratories Clauses 186 – 188

BS Violations and financial penalties Clauses 189- 194

BT Power to enter, search and seize Clauses 195 – 197

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BU Cognizance of offences and procedure for trial Clauses 198- 201

Chapter 12 MEDICAL DEVICE SAFETY APPELLATE TRIBUNAL

BV Establishment of Medical Device Safety Appellate Tribunal Clauses 202 – 205

BW Procedures and powers of Tribunal Clauses 206 – 210

Chapter 13 OFFENCES AND PENALTIES

BX Notification of fines / financial penalties in the rules Clause 211

BY Penalty for medical device that does not conform to this Act Clause 212

BZ Penalty for a misbranded medical device Clause 213

CA Penalty for tampering with a medical device Clause 214

CB Penalty for failure to comply with the directions of the IMDA

etc.

Clause 215

CC Punishment for false information Clause 216

CD Punishment for carrying out business without registration Clause 217

CE Punishment for interfering with seized items Clause 218

CF Punishment for obstructing a IMDA officer Clause 219

CG Punishment for subsequent offences Clauses 220 – 222

CH Penalty for contravention of provisions of this Act in case of

import of medical devices in addition to penalties provided

under any other Act

Clauses 223-224

CI Forfeiture of property Clause 225

CJ Offences by companies Clauses 226-228

CK Bar of suits in civil courts Clause 229

CL Power to compound offences Clauses 230-231

Chapter 14 FINANCES AND ACCOUNTS OF IMDA

CM Budget of IMDA Clauses 232- 233

CN Finances of IMDA and notification / collection of fees Clauses 234- 235

CO Exemption from tax on wealth and income Clause 236

CP Accounts and audits of IMDA Clauses 237- 239

CQ Annual report of IMDA Clauses 240- 241

Chapter 15 MISCELLANEOUS

CR Power of central government to issue directions to IMDA and

obtain reports

Clauses 242-244

CS Legal status of MDSA, IMDA members and employees Clauses 245

CT Power to make rules Clauses 246 – 247

CU Power of IMDA to make regulations Clauses 248-250

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CV Rules and regulations to be laid before Parliament Clause 251

CW Delegation Clauses 252

CX Power to remove difficulties Clauses 253-254

CY Repeal and saving Clauses 255-256

Chapter 16 TRANSITIONAL ARRANGEMENTS

CZ Transitional Arrangements Clause 257 – 260

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THE MEDICAL DEVICES SAFETY BILL, 2008

No XX of 2008

A BILL

To consolidate laws related to medical devices and to establish the Indian

Medical Device Authority for establishing and maintaining a national system of

controls relating to quality, safety, efficacy and availability of medical devices that

are used in India, whether produced in India or elsewhere and exported from

India.

Be enacted by the Parliament

In the Fifty Ninth Year of the Republic of India as follows:

CHAPTER 1: PRELIMINARY

AA 1) This Act may be called The Medical Device Safety Act, 2008

2) It extends to the whole of India

3) It shall come into force on such date as the Central Government notifies

in the Official Gazette, the FIRST SET OF REGULATIONS as provided

for under Chapter 15 and this first set of regulations shall include the

transitional time deadlines and arrangements as provided for under

Chapter 16.

4) The various provisions of this Act shall come into effect as per the

schedule to be notified in the regulations, but such time periods shall

not extend beyond 5 years from the date of first notification under

clause (3) above; thereafter the design, manufacture, packaging,

labeling, import, export, sale, usage and disposal of medical devices in

India shall be in accordance with the provisions of this Act.

Short title,

extent and

commencement

AB 5) Having regard to the proposal for ensuring the safety of the public in the

use of medical devices, and the fact that the content and scope of the

present laws of the country including the regulations and administrative

provisions in force do not extend to and cover adequately the safety,

health protection and performance characteristics of medical devices;

and that in the amendments to the Drugs and Cosmetics Act, 1940, the

scope of the definition of the expression ‘drugs’ has been extended to

cover ‘devices’; whereas this definition does not adequately cover all

the products which are covered by the current internationally accepted

definition of ‘medical devices’;

6) Whereas it is clear from international experience in the regulation and

use of medical devices, that the optimum assurance of medical device

safety has several essential elements, viz.:

Absolute safety cannot be guaranteed

It is a risk management issue

It is closely aligned with device effectiveness / performance

It must be considered throughout the life span of the device

Preamble

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It requires shared responsibility among the stakeholders

7) Whereas a diverse range and multitude of medical devices are in use,

which are manufactured using a wide variety of technologies with the

result that for ensuring the safety of the public in the use of medical

devices an entirely different system and method of regulation from the

current national and international practices that are being applied for the

regulation of drugs and cosmetics is required;

8) Whereas, the national provisions for the safety and health protection of

patients, users and, where appropriate, other persons, with regard to

the use of medical devices should be harmonized with global provisions

in order to guarantee the free movement of such devices within the

country and into the global market;

9) Whereas, to ensure that medical devices should provide patients, users

and third parties with a high level of protection and attain the

performance levels attributed to them by the manufacturer; it is

necessary to improve, the level of regulation, supervision and control

over medical devices manufactured in or imported into the country;

AC 10) Therefore, it is found expedient in the public interest, that the Union

should enact a law to bring under its control the safety and performance

of all medical devices.

11) This Act shall not apply to the following products

a) Medicinal products and cosmetics covered by the Drugs and

Cosmetics Act, 1940, except those coming under the definition of

“devices” or “medical devices” therein;

b) human blood, human blood products, human plasma or blood cells

of human origin or to devices which incorporate at the time of

placing on the market such blood products, plasma or cells;

c) transplants or tissues or cells of human origin nor to products

incorporating or derived from tissues or cells of human origin;

d) transplants or tissues or cells of animal origin, unless a device is

manufactured utilizing animal tissue which is rendered non-viable or

non-viable products

Declaration as

to the

expediency of

control by the

Union

AD 12) In this Act, unless the context otherwise requires: -

a) Accessory: means an article which though not being a device is

intended specifically by its manufacturer to be used together with or

as part of a device to achieve the intended use of the same by the

manufacturer of the device.

b) Adverse event: of a medical device is the occurrence of an event

related to the device that potentially can or does result in permanent

impairment, injury or death to the patient, user or other person as a

result of:-

i) a malfunction or deterioration in the characteristics or the

intended performance of the device;

ii) an inadequate design or manufacture of the device

iii) an inaccuracy in the labeling, instructions for use and/or

Definitions

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promotional materials including omissions and deficiencies

iv) a significant public health concern

v) other information becoming available like results of testing

carried out

c) Advertisement: means any audio or visual publicity,

representation or pronouncement made by means of any light,

sound, smoke, gas, print, electronic media, internet or website and

includes publication through any notice, circular, label, wrapper,

invoice, books, magazines or other documents or other media;

d) Audit: a systematic and independent examination to determine

whether activities and related results comply with planned

arrangements and whether these arrangements are implemented

effectively and are suitable to achieve the objectives.

e) Authorized Representative: means any natural or legal person

established in India explicitly designated by a manufacturer, to

legally represent it in India with regard to their obligations under this

Act, acts for the manufacturer and may be addressed by IMDA,

other authorities and bodies instead of the manufacturer.

f) Authority: means the Indian Medical Devices Authority (also

hereinafter referred to as IMDA) established under this Act.

g) CEO: means, the Chief Executive Officer of IMDA.

h) Clinical evaluation: The review of relevant scientific literature

and/or the review and assessment of data collected through clinical

investigation.

i) Clinical investigation: Any designed and planned systematic study

in human subjects undertaken to verify the safety and/or

performance of a specific device.

j) Conformity Assessment: the systematic examination of evidence

generated and procedures undertaken by the manufacturer, under

requirements of this Act to determine that a medical device

conforms to the Essential Principles of Safety and Performance for

Medical Devices.

k) Conformity Assessment Certificate: A certificate issued by a

Notified Body certifying that a medical device manufactured by a

manufacturer conforms to the requirements of this Act.

l) Date expired medical device: means medical devices, which have

exceeded its shelf life period or date of expiry, if any as indicated in

the device label.

m) Device for self-testing/self-administration: Any device intended

by the manufacturer to be able to be used by lay persons in a nonclinical

environment.

n) Efficacy: with reference medical device means, quality established

through a valid scientific evidence that a medical device would

produce an intended clinical effect on a target population;

o) Import: bringing into India any medical device by land, sea or air;

p) Intended use / purpose: use for which the medical device is

intended according to the information provided by the manufacturer

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on the device, label, cover or packing material or in the instructions,

booklet or leaflet and/or in promotional materials accompanying the

product;

q) In vitro diagnostic medical device: a medical device which -

a) is a reagent, reagent product, calibrator, control material, kit,

instrument, apparatus, equipment or system, whether used

alone or in combination; and

b) is intended by the manufacturer to be used in vitro for the

examination of specimens, including blood and tissue

donations, derived from the human body, solely or principally

for the purpose of providing information -

(i) concerning a physiological or pathological state,

(ii) concerning a congenital abnormality,

(iii) to determine the safety and compatibility of donations,

including blood and tissue donations, with potential

recipients, or

(iv) to monitor therapeutic measures,

and includes a specimen receptacle but not a product for general

laboratory use, unless that product, in view of its characteristics, is

specifically intended by its manufacturer to be used for in vitro diagnostic

examination;

r) Label: means any tag, brand, mark, pictorial or other descriptive

matter, written, printed stenciled, marked, embossed, graphic

drawn, perforated, stamped or impressed on or attached to the

container, cover, lid of any medical device package and includes

the literature or instruction provided by the manufacturer within the

medical device package (usually known as product insert);

s) Mandatory Standards: Recognised standards, whose

implementation are deemed mandatory for specific devices,

procedures, manufacturing processes, quality management

systems and the like.

t) Manufacturer: means - the natural or legal person with

responsibility for the design, manufacture, packaging and labelling

of a medical device, assembling a system, or adapting, refurbishing

or labelling one or more ready-made products or assigning to them

their intended purpose as a medical device before it is placed on

the market or put into service regardless of whether these

operations are carried out by that person or on that person’s behalf

by a third party.

“Design and/or manufacture”, as referred to in the above definition,

may include:

a. specification development, production, fabrication, assembly,

processing, packaging, repackaging, labelling, relabelling,

sterilization, installation, or remanufacturing; and/or

b. assembly, packaging, processing and/or labelling of one or

more finished products.

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u) Medical device: any instrument, apparatus, implement, machine,

appliance, implant, in vitro reagent or calibrator, software, material

or other similar or related article:

c) intended by the manufacturer to be used, alone or in

combination, for human beings for one or more of the specific

purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of

disease,

diagnosis, monitoring, treatment, alleviation of or

compensation for an injury,

investigation, replacement, modification, or support of the

anatomy or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information for medical or diagnostic purposes by

means of in vitro examination of specimens derived from the

human body;

And

d) which does not achieve its primary intended action in or on the

human body by pharmacological, immunological or metabolic

means, but which may be assisted in its intended function by

such means;

v) Medical device intended for clinical investigation: means any

medical device intended for use by a duly qualified medical

practitioner or by a person authorized to use the same by virtue of

his professional qualifications for conducting investigations in an

adequate human clinical environment;

w) Medical device testing laboratory: means any medical device

laboratory or Institute established by the Central or a State

Government or any other agency and accredited to the National

Accreditation Board for Testing and Calibration Laboratories

(NABL) or an equivalent accreditation agency and/or recognized by

IMDA;

x) Misbranded product: means an article of medical device of any of

following categories where it purports, or is represented to be, or is

being –

(i) offered or promoted for sale with false, misleading or

deceptive claims either upon the label of the package, or

through advertisement, or where it is sold by a name which

belongs to or is misleadingly similar to another article of

medical device or product ; or offered or promoted for sale

under the name of a fictitious individual or company

claiming to be the manufacturer or the producer of the

article as borne on the package containing the article or the

label on such package;

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(ii) where it is sold in package which have been sealed or

prepared by or at the instance of the manufacturer or

producer bearing his name and address but the article is

actually an imitation of, or is a substitute for, or resembles

in a manner likely to deceive a person to believe that it is

another article of medical device marketed under the name

under which it is sold, and is not plainly and conspicuously

labeled so as to indicate its true character; or the package

containing the article or the label on the package bears any

statement, design, or device regarding structure of the

product contained therein, which is false or misleading in

any material particular, or if the package is otherwise

deceptive with respect to its contents; or the article is

offered for sale as the product of any place or country

which is false;

(iii) if the article with in the package contains any component

which is not mentioned in the declarative label, or the

package is not labeled in accordance with the requirements

of this Act, or contravenes any of the provisions of this act,

or the rules and regulations made thereunder; or is offered

for sale for special uses, unless its label bears such

information as may be specified by rules and regulations as

might be prescribed , concerning its components in order

sufficiently to inform its purchaser as to its value for such

use;

y) Notified Body: means a body corporate or other legal entity

notified by the IMDA as competent to carry out Conformity

Assessment of Medical Devices as per the requirements of this Act

z) Package: means box, bottle, casket, case, pouch, receptacle, bag,

wrapper, container, or other thing in pre-packed condition, in which

the medical device is subsequently packed;

aa) Performance: means, satisfactory functioning of the medical

device as intended and in accordance with the declarations in the

associated labeling and in conformity with applicable technical

specifications and relevant product standards;

bb) Performance evaluation: Review of the performance of a medical

device based upon data already available, scientific literature and,

where appropriate, laboratory, animal or clinical investigations.

cc) Placing on the market: means the making available in stores,

shops, or any other market place for sale or distribution of a

product, whether in return for a price, or payment or even free of

any such charges, of a medical device other than a medical device

intended for clinical investigation, with a view to market the same in

India regardless of whether the product or device is new or

refurbished;

dd) Predicate Device: means a medical device which is legally

marketed in India by meeting the requirements of this Act.

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ee) Putting into service: means the stage at which a medical device,

ready for use, is introduced in India for the first time for use for

intended purposes;

ff) QMS: Quality Management System(s) that may be notified by IMDA

in the regulations to be applied by medical devices manufacturers,

Notified Bodies or other organizations covered under this Act.

gg) Recognised Standards: Standards deemed to offer the

presumption of conformity to specific essential principles of safety

and performance and which have been notified by IMDA.

hh) Record: document stating results achieved or providing evidence of

activities performed

ii) Refurbished device: means a medical device, or a part of the

device, which is substantially rebuilt from one or more used medical

devices of that kind so as to create a medical device that is able to

be used for the purpose originally intended by the manufacturer of

the original device;

jj) Registration: means the registration of medical device(s) under

this Act;

kk) Regulations: means regulations made and notified by the IMDA

under this Act;

ll) Risk: combination of the probability of occurrence of harm and the

severity of that harm.

mm) Risk management: in relation to medical device means,

systematic application of management policies, procedures and

practices to the tasks of analyzing, evaluating, controlling and

monitoring risk;

nn) Rules: the rules made and notified by the Government of India

under this Act;

oo) Safety: freedom from unacceptable risk;

pp) Sale: with its grammatical variations and conjugate expressions

means, the transfer of possession of a medical device, whether for

cash or on credit or by way of exchange and whether wholesale or

retail, for human consumption or use, or for analysis, and includes

not only an agreement for sale, an offer for sale, the exposing for

sale or having in possession for sale of any such article, but also an

attempt to sell any such article;

qq) Standard: in relation to medical devices means, any standard

developed by national or international standard making bodies and

notified by the IMDA;

rr) Sterile medical device: means medical device intended to meet

the requirements for sterility;

ss) Summary Technical Documentation (STED): a summary of

technical documentation held or submitted for conformity

assessment purposes.

tt) Technical Documentation: the documented evidence, normally an

output of the quality management system, which demonstrates

compliance of a device with the Essential Principles of Safety and

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Performance of Medical Devices.

uu) Tribunal: means the Medical Device Safety Appellate Tribunal

established under this Act;

CHAPTER 2: INDIAN MEDICAL DEVICE AUTHORITY

AE 13) The Central Government shall, by notification, establish a body to be

known as the Indian Medical Device Authority (hereinafter called as

IMDA) to exercise the powers conferred on, and to perform the functions

assigned to, it under this Act.

14) The IMDA shall be a body corporate by the name aforesaid, having

perpetual succession and a common seal with power to acquire, hold

and dispose of property, both movable and immovable, and to contract

and shall, by the said name, sue or be sued.

15) The head office of the IMDA shall be at New Delhi.

16) The IMDA may, in its discretion, establish its regional offices at any

other place in India also.

Establishment

of Indian

Medical Device

Authority

(IMDA)

AF 17) The GOVERNING BODY of IMDA shall consist of the following nine

members to be appointed by the Central Government, namely

a) Two Members, to be nominated by the central government, not

below the rank of Additional Secretary to the Government of India or

equivalent rank to represent the Ministries or Departments of the

Central Government dealing with

i) Science & Technology (ex-officio)

ii) Health (ex-officio)

b) One eminent jurist, to be nominated by the Central Government in

the manner prescribed by rules

c) Two eminent medical practitioners, to be nominated by the Central

Government in the manner prescribed by rules

d) Two eminent medical device scientists or engineers, to be

nominated by the Central Government in the manner prescribed by

rules

e) Secretary General of Quality Council of India (ex-officio)

f) Chief Executive Officer (CEO) of IMDA (ex-officio) - Secretary

18) There shall be a Chairperson of the IMDA who shall be nominated by

the Central Government from among the members other than the CEO

and the ex-officio members of the Governing Body. The Chairperson

shall exercise such powers and discharge such functions as are laid

down in this Act or as may be prescribed by rules or regulations.

19) The CEO of the IMDA shall be appointed by the Central Government on

the recommendations of a selection committee to be constituted by it.

The selection shall be made in such a manner as to ensure the highest

standards of competence and broad range of relevant expertise;

regards being had also to the aspect of geographic representation from

within the country.

Composition of

Governing

Body of IMDA

and

appointment of

the

Chairperson,

CEO and

Members

AG 20) The Central Government shall, for the purpose of selection of the CEO, Committee for

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constitute a selection committee consisting of:

a) Cabinet Secretary – Chairperson

b) Secretary, Department of Science and Technology, Government of

India as convener-member

c) Secretaries from the Departments or Ministries of Health, Law and

Personnel, Govt. of India– members

d) Chairman of the Public Enterprises Selection Board – member

e) An eminent medical device technologist to be nominated by the

Central Government – member

Explanation: For the purpose of the sub clause (e), the Central

Government shall nominate a person from amongst persons holding

the post of Director or the Head, by whatever name called, of any

national research or technical institution in the area of medical

devices.

21) The Central Government shall, within two months from the date of

occurrence of any vacancy by reason of death, resignation or removal of

the CEO of the IMDA and three months before the superannuation or

completion of the of office of the CEO, make a reference to the

Selection Committee for filling up the vacancy.

22) The Selection Committee shall finalise the selection of the CEO within

two months from the date on which the reference is made to it.

23) The Selection Committee shall recommend a panel of two names for

every vacancy referred to it.

24) Before recommending any person for appointment as a CEO of the

IMDA, the Selection Committee shall satisfy itself that such person does

not have any financial or other interest, which is likely to affect

prejudicially his functions.

25) No appointment of the CEO shall be invalid merely by reason of any

vacancy in the Selection Committee

the selection of

CEO of IMDA

AH 26) The term of office of a Member of the GOVERNING BODY other than

ex officio Members shall be five years from the date on which they enter

upon their offices, and shall be eligible for re-appointment for a further

period of three years.

27) The term of office of an ex officio member of GOVERNING BODY shall

continue so long as he holds the office by virtue of which he is such a

member

28) The chairperson and other members shall receive such allowances, if

any, from the IMDA as may be prescribed by rules.

29) The Chairperson of IMDA shall have a rank not below that of a

Secretary to the Government of India and the CEO, not below the rank

equivalent to that of Additional Secretary to the Government of India

30) The Chairperson, CEO and every Member shall, before entering upon

his office, make and subscribe to an oath of office and of secrecy in

such form and in such manner and before such authority as may be

prescribed by the Central Government

31) Notwithstanding anything contained in Clauses ( 26) and (27), the

Term of office

of the

members of

GOVERNING

BODY

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Chairperson, CEO or any Member may:

a) Relinquish his office by giving in writing to the Central Government

a notice of not less than three months; or

b) Be removed from his office in accordance with the provisions of

Clause (33).

32) The Chairperson, CEO or any Member ceasing to hold office as such

shall not represent the cause of any person, firm or company before the

IMDA in any manner thereafter.

AI 33) Notwithstanding anything contained in Clauses (26) and (27), the

Central Government may, by order, remove from the IMDA, its

Chairperson, or any other Member of the Governing Body, if he

a) has been adjudged an insolvent; or

b) has been convicted of an offence which, in the opinion of the

Central Government, involves moral turpitude: or

c) has become physically or mentally incapable of acting effectively as

a Member; or

d) has acquired such financial or other interests as is likely to affect

prejudicially the discharge of his functions as a Member; or

e) has so abused his position as to render his continuance in office

prejudicial to the public interest.

34) No Member shall be removed under sub clauses (d) and (e) of Clause

(33) unless he has been given a reasonable opportunity of being heard

in the matter.

Removal of

Chairperson

and Members

of Governing

Body

AJ 35) It shall be the objective of the IMDA to regulate and monitor the design,

testing & evaluation, manufacture, packaging, labeling, import, sale,

usage and disposal of medical devices, so as to ensure availability of

safe medical devices for human use in the country and when exported

from India.

36) With a view to the implementation of the objects specified in clause (35),

the IMDA maya)

Provide for notification of essential principles of safety and

performance of a medical device and the requirements for design

and manufacturing

b) Provide for risk based classification of medical devices

c) Notify the standards and guidelines in relation to medical devices

and specify an appropriate system for enforcing various standards

notified under this Act;

d) Notify suitable standards and guidelines for risk management

system to be applied by manufacturers during the entire device lifecycle

and specify appropriate criteria for risk acceptability.

e) Provide for a mechanism for conformity assessment using third

party notified bodies

f) Provide for a system of registration of medical devices meeting the

requirements of this Act

g) Notify the method of identification of conformity by assigning marks

Objects and

functions of

IMDA

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or other means

h) Specify the requirements pertaining to conformity assessment of all

medical devices including refurbished devices, date expired

devices, custom made devices and other special cases

i) Stipulate the procedure and guidelines for testing laboratories and

notification of the same;

j) Provide for the exchange of information among the notified bodies

and other enforcement authorities

k) Prescribe methodology for implementing and operating a vigilance

and post-market surveillance system and taking preventive and proactive

measures

l) Ensure that the advertising related to medical devices follow the

guidelines notified in the regulations

m) Provide for enforcement of the various provisions stipulated in this

Act and those relating to offences

n) provide for all or any of the other matters as specified in this Act

37) It shall also be the duty of the IMDA to

a) provide scientific advice and technical support to the Central

Government and the State Governments in matters of policy and

principles in areas which have a direct or indirect bearing on

medical device safety and efficacy

b) search, collect, collate and analyze relevant scientific and technical

data particularly relating to:

i) hazards with the use of medical devices

ii) the exposure of individuals to risks related to the use of medical

devices

iii) incidence and prevalence of risks associated with medical

devices

iv) identification of emerging risks and

v) introduction of effective vigilance system

c) promote, co-ordinate and issue guidelines for the development of

risk assessment methodologies and monitor, conduct and forward

messages on the risks associated with medical devices to the

Central Government, State Governments and other enforcement

agencies;

d) provide scientific and technical advice and assistance to the Central

Government and the State Governments in implementation of crisis

management procedures with regard to medical device safety and

to draw up a general plan for crisis management and work in close

co-operation with the crisis units set up by the Central Government

in this regard.

e) promote networking of national and international organizations

within and outside India with the aim of facilitating scientific cooperation,

co-ordination of activities, exchange of information,

implementation of joint projects and exchange of expertise, within

the areas of operation of IMDA

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 16 of 49

Page 16 of 49

f) provide scientific and technical assistance to the Central

Government and the State Governments for improving co-operation

with international organizations

g) take all such steps to ensure that the public, medical professionals

and interested parties receive rapid, reliable, objective and

comprehensive information through appropriate methods and

means

h) provide, whether within or outside their area, training in medical

device safety and standards for persons who are or intending to

become involved in medical device businesses, whether as

entrepreneurs or employees or otherwise

i) contribute to the development of national / international technical

standards for medical devices

j) contribute, where relevant and appropriate, to the development of

agreements, national or international, aimed towards

standardization of metrology relating to medical devices

k) support international efforts to improve and harmonize standards

relating to medical devices and regulatory practices

l) promote consistency between international standards and national

medical device standards while ensuring that the level of protection

adopted in the country is not reduced; and

m) promote general awareness as to medical device safety and

medical device standards

n) undertake any other task assigned to it by the Central Government

to carry out the objects of this Act

o) provide guidance and support to industry to understand and comply

with the requirements of this Act.

38) Subject to the provisions of the Right to Information Act 2005 and

except where such disclosure is necessary to protect public health, the

IMDA and its officers and employees shall not disclose or cause to be

disclosed to third parties, information that it receives from others with

liability to maintain confidentiality.

AK 39) The IMDA shall make regulations prescribing procedures with regard to

the transaction of business at its meetings, notice, quorum, place of

sitting etc. and follow the principles of equity, justice and good

conscience in its procedures.

40) If the Chairperson is unable to attend a meeting of the IMDA, any other

member nominated by the Chairperson on his behalf and, in the

absence of such nomination or where there is no Chairperson, any

member chosen by the members present from amongst themselves,

shall preside at the meeting.

41) No act or proceedings of the IMDA shall be questioned or invalidated

merely on the ground of existence of any vacancy or defect in the

constitution of the IMDA.

42) The Governing Body of IMDA shall meet as frequently as is necessary

but not less than four times a year. The meetings may be convened at

the initiative of the CEO or on directions of the Chairperson.

Proceedings of

IMDA

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 17 of 49

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AL 43) The IMDA may, with the approval of the Central Government, determine

the number, nature and categories of officers and other employees

required by the IMDA for the discharge of its functions.

44) Subject to such rules as may be made in this behalf, the IMDA may

appoint such number of officers and employees as may be necessary

for the exercise of its powers and discharge of its functions and may

determine the designations and grades of such officers and employees.

45) Subject to such rules as may be made in this behalf, the CEO and

other officers and employees of the Institute shall be entitled to such

salary and allowances and shall be governed by such conditions of

service in respect of leave, pension, gratuity, provident fund and

other conditions of service as may be prescribed by regulations made

in this behalf.

Staff of IMDA

AM 46) The CEO shall be the secretary and convener of the Governing Body.

CEO and shall be responsible for -

a) convening the Governing Body meetings and other committees

b) the day-to-day administration of the IMDA

c) drawing up of proposal for the IMDA’s work programmes in

consultation with the Advisory Committees

d) implementing the work programmes and the decisions adopted by

the Governing Body.

e) ensuring the provision of appropriate scientific, technical and

administrative support for the IMDA

f) ensuring that the IMDA carries out its tasks in accordance with the

requirements of its users, and in particular, with regard to the

adequacy of the services provided and the time taken

g) the preparation of the statement of revenue and expenditure and

the execution of the budget of the IMDA and

h) Developing and maintaining contact with the Central Government,

and for ensuring a regular interaction with its Advisory Committee

and Technical Panels.

47) Every year, the Chief Executive Officer shall submit to the Governing

Body for approval

a) Annual report covering all the activities of the IMDA in the previous

year

b) programmes of work for the next year

c) the annual accounts for the previous year and

d) the budget for the coming year

48) The Governing Body, from time to time, may give directions, on matters

relating to medical device safety and standards, to the CEO, who shall

be bound by such directions while exercising his powers under this Act;

49) The CEO shall approve all expenditure of the IMDA and report on the

IMDA’s activities to the Central Government.

50) The CEO shall have administrative control over the officers and other

employees of the IMDA.

Functions of

the Chief

Executive

Officer

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Page 18 of 49

AN 51) The IMDA shall, by notification, establish an Advisory Committee

consisting of the following members:

a) CEO as the Chairperson

b) A senior officer of IMDA nominated by the Governing Body as the

Secretary & convener (preferably the person responsible for

coordination with other regulatory agencies)

c) Representative of the following ministries or departments of:

i) Total of two from Science & Technology / National GLP

Compliance Monitoring Authority / National Accreditation Board

for Laboratories

ii) One from Biotechnology / Biotechnology regulatory board

iii) Total of two from Director General of Health Services / Drugs

Controller General of India / Indian Council for Medical

Research

iv) One from Atomic Energy / Atomic Energy Regulatory Board

v) One from Ministry of Information Technology or an Expert in

Electronic Instrumentation and electromagnetic interference

regulation;

d) Two representatives of the medical device industry, of whom at

least one shall be from the small or medium scale enterprise

e) Director General of Bureau of Indian Standards

f) Two biomedical engineers

g) Two biomaterial scientists

h) Member(s) of IMDA & Chairpersons of the Technical Panels on

invitation of the chairperson of advisory committee, as and when

deemed necessary,

Advisory

Committee

AO 52) The Advisory Committee shall facilitate and ensure close co-operation

between the IMDA and the enforcement agencies and other

organizations operating in the healthcare sector.

53) The Advisory Committee shall advise the IMDA on matters such as:

a) the performance of its duties and in particular in drawing up of a

proposal for the IMDA’s work programme,

b) identification of experts for technical panels and functioning of the

technical panels

c) selection of standards including that for risk benefit analysis of

medical devices

d) functioning of notified bodies and testing laboratories

e) vigilance and post market surveillance of medical devices

f) view points of the medical device industry and healthcare

professionals

g) matters of interdisciplinary nature

h) matters relating to reuse, refurbished devices, donated device,

custom made devices, devices for clinical investigation etc. and also

of safe disposal thereof after use

Functions of

Advisory

Committee

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i) regulations and strategies in the context of emerging areas of

scientific advancement and technological developments

j) interactions with other regulatory bodies in the country

k) developments in the medical device industry in the global context,

and

l) such other matters as may be specified by regulations.

54) The Advisory Committee shall meet regularly but not less than two times

a year, at the initiative of the convener or on directive of the

Chairperson.

AP 55) The IMDA shall, and as and when deemed necessary, establish

Technical Panels, which shall consist of independent scientific experts.

56) The Technical Panel may also invite appropriate representatives of the

relevant segments of (a) industry, (b) medical profession, (c) medical

device experts and researchers and (d) public interest groups for

deliberations and seeking inputs so as to ensure that its

recommendations are relevant and technically up to date.

57) IMDA shall create the following FOUR Technical panels as standing

panels for matters pertaining to:

a) Classification of medical devices and disputes regarding the same

b) Conformity assessment and Technical standards

c) Medical device testing and evaluation

d) In vitro diagnostic devices

58) Without prejudice to the provisions of clause ( 55) and clause ( 56), the

IMDA may also establish as many Technical panels as it considers

necessary on matters such as:

a) Good manufacturing practices and quality systems

b) Medical device packaging and sterilization

c) Medical instrumentation

d) Radiation safety

e) Clinical investigation and biomedical ethics

f) Risk Management of medical devices and risk benefit assessment

g) Sector wise such as

i) Anesthesiology and Respiratory Therapy Devices

ii) Cardiovascular devices

iii) Dental products

iv) ENT devices

v) Gastroenterology and Urology devices

vi) Plastic surgery devices

vii) Obstetrics and Gynecology devices

viii) Ophthalmic devices

ix) Orthopedic and Rehabilitation devices

x) Hospital disposables

Technical

Panels

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Page 20 of 49

xi) Neurological devices

xii) Radiological devices

xiii) Biological devices

xiv) combinational products

xv) imaging,

xvi) rehabilitation,

xvii) prevention

and other areas as required from time to time

59) The Technical panels excepting those mentioned in clause (56), above

may be constituted for a specified period of time or for a specific task.

The IMDA may, from time to time, re-constitute the Technical panels by

adding new members or by omitting the existing members or by

changing the name of the panel as the case may be.

60) The Technical Panels may have independent chairpersons and the

chairpersons of these Technical panels may be invited to the meetings

of the Governing Body or the Advisory committee as deemed

necessary.

61) The IMDA shall, for stated reasons, be at liberty to accept or not, the

recommendations or scientific opinions given to it by the Technical

panels.

62) The CEO shall be responsible for the general coordination necessary to

ensure consistency of the scientific procedure and in particular with

regard to the adoption of working procedures and harmonization of

working methods of the Technical Panels.

63) The Advisory Committee shall advise the IMDA on the identification of

experts to be nominated to the Technical Panels so as to utilize the

expertise of such persons while formulating scientific opinions and

strategies.

AQ 64) The provisions in the regulations shall govern the procedure for the

operation and co-ordination of the advisory committee and the Technical

Panels.

65) The regulations to be framed shall prescribe the principles and

procedures governing the following among others -

a) the number of members in each Technical Panel;

b) the procedure for sitting fees and the procedure for reimbursing the

expenses of members of the advisory committee and Technical

Panel;

c) the procedural aspects governing the assignments and discharge of

the duties and responsibilities of the Advisory committee and

Technical Panel;

d) Quorum for meetings, the manner of issuing notices to members

and invitees for hearings, and such other matters.

Procedure for

Advisory

Committee and

Technical

Panels

AR 66) The CEO, staff members of IMDA and the four Chairpersons of the

standing technical panels shall meet with representatives of the medical

devices industry in the country regularly, but at least once in a year and

Industry and

Public

Consultation

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 21 of 49

Page 21 of 49

hold discussions for obtaining their feedback related to :

i) Problems and difficulties faced by the industry in complying with

the requirements of this Act

ii) Suggestions for improvements

iii) Complaints on specific issues

iv) Issues related to functioning of Notified bodies and problems if

any

v) Issues related to export requirements to other countries, where

IMDA can help

vi) And other matters, if any, raised by the industry

67) The CEO and staff members of the IMDA shall organize and meet with

representatives of the public at different parts of the country on a regular

and planned basis, at least twice a year to:

i) Receive complaints related to medical devices and

manufacturers;

ii) Suggestions for improvements

iii) Issues related to misleading labels, advertisements,

instructions, and the like

iv) Educate and inform the public about the benefits being derived

from the implementation of this Act

v) And other matters / issues brought to the notice

68) Members of the Governing Body of IMDA, Advisory Committee and

other technical panel may also be invited to participate in these

meetings as required and necessary so that a broad range of issues can

be discussed and addressed.

69) All such meetings and the feedback received shall be well documented.

IMDA shall analyse the feedback received and take suitable action

within 4 months of holding such meetings. Reports of such meetings,

actions taken and any delay in resolving specific items shall be reported

at the next meeting of the Governing Body.

70) IMDA shall, if necessary consult the appropriate technical panel and or

the Advisory committee before deciding on suitable action; all such

action taken shall be reported to the Governing Body .

AS 71) The Government shall constitute a Review Committee consisting of

experts, external to IMDA, to review the performance of IMDA, at least

once in 10 years and make suitable recommendations for improvement

and changes in the structure and functioning of IMDA, so that IMDA can

cope with the changes in the market and risk perceptions.

72) The final report of the Review Committee shall be tabled in both houses

of Parliament.

Review of

IMDA

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Page 22 of 49

CHAPTER 3: ESSENTIAL PRINCIPLES OF MEDICAL DEVICE SAFETY,

AND PERFORMANCE; DESIGN & MANUFACTURING REQUIREMENTS

AT 73) All medical devices placed on the Indian market must meet the following

requirements of the ESSENTIAL PRINCIPLES of SAFETY AND

PERFORMANCE, namely : -

a) Use of medical devices should not compromise health and safety

b) Design and manufacture of medical devices must conform with

safety principles

c) Medical devices should be suitable for the intended purpose and

achieve the performance intended

d) Long-term safety must be assured

e) Medical devices should not be adversely affected by transport or

storage

f) Benefits of medical devices must outweigh the risks associated with

the use of the device

74) IMDA shall issue regulations relating to:

a) General requirements that manufacturers must meet so that devices

achieve the performance intended by them during the lifetime of

their use, so as to satisfy the requirements of Essential principles of

Safety and Performance as laid in the clauses above.

b) Design and Manufacturing requirements bearing in mind the

following:

i) Chemical, physical and biological properties

ii) Infection and microbial contamination

iii) Manufacturing and environment properties

iv) Devices with a diagnostic or measuring function

v) Protection against radiation, including ionizing, non-ionizing

radiation and covering electromagnetic compatibility

requirements to ensure overall safety in the environment and

also complying with the national laws relating to

electromagnetic compatibility and ionizing radiation

vi) Requirements for medical devices connected to or equipped

with an energy source

vii) Protection against mechanical risks

viii) Protection against the risks posed to the patient by supplied

energy or substances

ix) Protection against the risks posed to the patient for devices for

self testing or administration

x) Information supplied by the manufacturer

xi) Performance evaluation including, where appropriate, clinical

investigation and evaluation

Note: the manufacturer can select the design and manufacturing

Essential

Principles of

Medical device

safety and

performance;

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 23 of 49

Page 23 of 49

requirements that are relevant to the device, documenting the reasons for

excluding the others. The Notified Body shall verify this decision during the

conformity assessment process.

75) The regulations, when framed, shall be notified by the IMDA in the

Gazette of India and placed before the parliament for ex-post facto

approval or changes.

76) These essential and other requirements must be interpreted and applied

in such a way as to take into account the technology and practice

existing at the time of design as also technical and economical

considerations compatible with protection of a high level of health and

safety.

CHAPTER 4: CLASSIFICATION OF MEDICAL DEVICES

AU 77) IMDA shall develop and apply a system of RISK BASED

CLASSIFICATION of medical devices and while doing so, bear in mind

that:

There is complexity and wide variety requiring classification of medical

devices so that the level of regulation can be proportional to the level of

risk associated with them

a) The level of risk inherent in the use of a particular device depends

substantially on its intended purpose and is defined by the nature or

degree of invasiveness of the human body and the duration of such

contact.

b) The level of risk also depends on whether the device delivers

medicinal products or energy to the patient, whether they are

intended to have a biological effect on the patient and local versus

systemic effects

78) The risk classification system may generally consist of four risk classes

namely

i) Class A- devices involving lowest risk levels

ii) Class B- devices involving low to moderate risks

iii) Class C- devices involving moderate to high risks

iv) Class D- devices involving highest risks

79) Under the regulations, it shall be open to the IMDA to frame the

‘Classification Rules’ for medical devices and publish the same in the

Gazette of India.

80) In framing such regulations for classification, IMDA shall ensure that the

following principles are followed:

a) Based on the manufacturer’s intended purpose, if two or more

classification rules apply to the device, the device is allocated the

highest level of classification indicated.

b) Where one medical device is intended to be used together with

another medical device, that may or may not be from the same

General

Principles of

risk based

classification

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 24 of 49

Page 24 of 49

manufacturer, the classification rules shall apply separately to each

of the devices.

c) Classification of an assemblage of medical devices that individually

comply with all regulatory requirements depends on the

manufacturer’s purpose in packaging and hence the combination

shall be classified as a whole according to its intended use.

d) Accessories intended specifically by manufacturers to be used

together with a ‘parent’ medical device to enable that medical

device to achieve its intended purpose, may be classified as though

it is a medical device in its own right.

81) It shall be open to the IMDA, in consultation with the Standing Technical

Panel on Classification, to take decisions with regard to the proper

classification or reclassification of the devices or, where appropriate, the

adjustment of the classification rules from time to time.

82) IMDA shall notify in the regulations a system for Medical Device

Nomenclature and coding. Such system may preferably be in conformity

with the systems being used internationally.

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Page 25 of 49

CHAPTER 5: MEDICAL DEVICE STANDARDS

AV 83) IMDA shall specify in the regulations, the requirements that form the basis

for conformity assessment of the medical devices, so that they may enable

the manufacturers to demonstrate conformity to the essential principles of

safety and performance.

84) These requirements may

a) provide reference criteria that a product, process or service must meet.

b) provide information that enhances safety, reliability and performance of

medical devices.

c) assure consumers about reliability or other characteristics of medical

devices

d) provide technical specifications or other precise criteria to be used

consistently as rules, guidelines or definitions of characteristics, to

ensure that medical devices are fit for their purpose.

85) Standards published by the Bureau of Indian Standards or other

international standards making bodies like International Organization for

Standardization (ISO), the International Electro-technical Commission

(IEC), and the International Telecommunication Union (ITU), standards in

the Indian Pharmacopoeia and other international Pharmacopoeia

monographs may be selected by IMDA based on their suitability and on the

recommendations of the Advisory Committee or Technical panel.

86) Based on the recommendations of the Advisory committee and / or

Technical Panel, IMDA may “RECOGNISE” certain standards by notifying

them in the Gazette of India under the regulations.

87) IMDA may also notify certain Recognised Standards as MANDATORY

standards.

88) Demonstration of compliance to these “RECOGNISED STANDARDS” shall

be deemed to satisfy the requirements for conformity to specific essential

principles of safety and performance or design and manufacturing

requirements.

89) While it is preferable for harmonization purposes to use international

standards, in some cases, it may be more appropriate for IMDA to accept

the use of national / regional standards, industry standards or other

established and validated techniques as a means of demonstrating

compliance.

90) The selection of standards should preferably reflect current, broadly

applicable technology while not discouraging the use of new technologies.

Note: Standards may represent the current state of the art in a

technological field. However, not all devices, or elements of device safety

and/or performance may be addressed by recognized standards, especially

for new types of devices and emerging technologies.

91) During the conformity assessment procedure, if it is found that a standard

does not exist for a particular medical device or a standard can not be

applied to it in full, the manufacturer might choose other means to

demonstrate compliance with the essential principles. These other means

must ensure the same level of safety and effectiveness and might be

based, where available, on requirements prescribed by IMDA.

Selection

and

application

of medical

device

standards

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Page 26 of 49

CHAPTER 6: CONFORMITY ASSESSMENT, REGISTRATION AND

PLACING MEDICAL DEVICES ON THE MARKET BY THE

MANUFACTURER

AW 92) Manufacturers are responsible for ensuring and demonstrating the

conformity of their medical devices to the Essential Principles of safety

and performance before and after placing them on the market.

93) Manufacturers shall select and apply one of the methods described in

the Chapter 7 clause (130) for conformity assessment, as may be

suitable to the particular medical device, depending on its risk

classification.

94) Compliance to applicable medical device standards is one way of

demonstrating conformity with the requirements of the essential

principles of safety and performance.

95) The use of standards is voluntary, except in those particular cases

where certain standards have been notified as ‘Mandatory’ by IMDA.

(Chapter 5, Clause 87)

96) Manufacturers may use “non-recognised” standards, in whole or in

part, or other methods of demonstrating conformity, which may include:

a) national and international standards that have not been given the

status of a "recognised standard"

b) industry standard

c) internal standard operating procedures developed by an individual

manufacturer and not related to international standard

d) current state of the art techniques related to performance, material,

design, methods, processes or practices

provided that, the validity and acceptability of such other methods

selected under Clauses ( 96) for proving conformity to the Essential

Principles shall be clearly demonstrated by the manufacturer to the

satisfaction of the Notified Body and/or IMDA.

Responsibilities

of the

manufacturer

AX 97) The manufacturer shall prepare, provide and retain documentation as

necessary, to demonstrate that the device complies with the Essential

Principles.

98) The technical documentation must allow assessment of the conformity

of the product with the requirements of this Act. It must include in

particular:

a) a general description of the device, including any variants

b) the intended use/purpose of the device

c) design drawings, methods of manufacture envisaged and

diagrams of components, sub-assemblies, circuits, and the like

d) the descriptions and explanations necessary to understand the

above mentioned drawings and diagrams and the functions of the

product

e) the results of Product Risk Management.

f) a list of the applicable standards referred to in Chapter 5 of this

Act, applied in full or in part, and descriptions of the solutions

adopted to meet the essential requirements of this Act, if the

Technical

documentation

demonstrating

conformity

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 27 of 49

Page 27 of 49

standards referred to in Chapter 5 have not been applied in full,

g) in the case of products placed on the market in a sterile condition,

description of the methods used for sterilization

h) when connected to any device(s) having the characteristics

specified by the manufacturer, the results of the design

calculations and of the inspections carried out, etc.

i) if the device is to be connected to other device(s) in order to

operate as intended, proof that it conforms to the essential

requirements

j) the test reports and, where necessary and required, clinical data

k) the label and accompanying information such as instructions for

use

99) Documentation may include, the standard itself (or the alternative

methods used), how it was applied, deviations, test results and/or other

data.

100) Where a standard is not applied, or is not applied in full, the

manufacturer should provide, as appropriate, data or information to

demonstrate:

i) that compliance with the Essential Principles has been achieved by

other methods, and

ii) if applicable, that the parts of the standard that were not applied

were not pertinent to the particular device.

101) A Summary Technical Document, containing the summary of all

the above detailed documentation shall be prepared and made

available by the manufacturer to the Notified Bodies and / or IMDA

when called for.

102) IMDA may specify in the regulations, the formats for preparation of

these Technical Documents.

103) The manufacturer or the Authorised Representative shall retain the

technical documentation pertaining to conformity assessment and

make available to IMDA for inspection purposes for a specified period

after the last product has been manufactured and sold; the specified

period shall be notified in the Gazette of India and may depend on the

class of the device.

Summary

Technical

Document

(STED)

AY 104) The manufacturer will put in place, as part of its quality

management system, a process to assess the continued conformity of

the device to the Essential Principles of Safety and Performance

through the post-marketing phase. This process will include at a

minimum

a) Complaint handling

b) Post-market vigilance reporting of adverse events and device

malfunction

c) Corrective & preventive actions

105) Manufacturers shall report to IMDA as soon as they become aware

of information regarding an adverse event, which has occurred with its

device. This includes situations where testing performed on the device,

System for

post-market

surveillance and

Adverse event

reporting

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Page 28 of 49

examination of the information supplied with the device or any scientific

information indicates some factor that could lead to or has lead to an

adverse event.

106) IMDA shall notify in the regulations, the requirements that

manufacturers should comply with, while reporting adverse events,

including,

a) The nature and type of the adverse events that are to be

reported

b) The nature and type of adverse events that are exempted from

reporting

c) Time limits for reporting

d) Where, how and whom to report

e) Analysis of such device related adverse events, malfunction

and follow-up action required

f) Submission of interim and final reports

g) Formats and the information to be provided in all such reports

h) And any other information that may be deemed essential from

time to time.

AZ 107) Where a manufacturer does not have a registered place of

business in India, they shall designate an Authorised Representative,

who is established legally in India. However, this shall not exonerate

the manufacturer from their responsibilities and obligations under this

Act.

108) After being satisfied that their medical device complies with the

Essential Principles of safety and performance, the manufacturer shall

draw up a written “DECLARATION OF CONFORMITY”, which contains

at least the following information:

a) An attestation that each device that is subject of the declaration:

i) complies with the applicable Essential Principles for Safety

and Performance,

ii) has been classified according to the classification rules as

notified in the regulations, and

iii) has met all the applicable conformity assessment

requirements.

b) Information sufficient to identify the device/s to which the

Declaration of Conformity applies.

c) Provide the Medical Device Nomenclature code and term for the

device as notified by the IMDA in the regulations.

d) The risk class allocated to the device(s) after following the

classification rules provided in the IMDA regulations.

e) The particular procedure for the conformity assessment described

in Chapter 7, that has been applied

f) Conformity Assessment Certificates received from Notified Bodies

after due conformity assessment as carried out depending on

device class.

Declaration of

conformity by

Manufacturer.

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Page 29 of 49

g) The date from which the Declaration of Conformity is valid.

h) The name and address of the device manufacturer.

i) The name, position /designation and signature of the responsible

person or the Authorised Representative, who has been authorized

by the manufacturer to complete the Declaration of Conformity on

their behalf, and

j) Legal status of the Authorised Representative.

109) The Manufacturer or their Authorised Representative in signing the

DECLARATION OF CONFORMITY legally declares that the medical

device meets with all the requirements of this Act.

110) IMDA may specify in the regulations, the formats for

DECLARATION OF CONFORMITY, which the manufacturer shall

follow and which may vary depending on the device classification and

the location of the manufacturer (e.g. within India or outside).

BA 111) Before placing a medical device on the market, the manufacturer

or his Authorized Representative shall APPLY for REGISTERATION of

the device with the IMDA by submitting a copy of the DELCLARATION

OF CONFORMITY and other required information.

112) On receipt of such applications for registration, IMDA shall issue a

receipt with a UNIQUE APPLICATION NUMBER to the manufacturer.

113) Such registration of medical devices placed on the Indian market

shall be mandatory, except in the following cases:

a) Class A devices which are NOT SUPPLIED STERILE or which do

not have A MEASURING FUNCTION.

b) Such other devices, which may be specifically notified in the

regulations by IMDA from time to time; reasons for exclusion shall

be disclosed in the notification.

c) While placing these exempt devices on the market, the

manufacturer shall comply with the requirements for MARKING as

specified in Chapter 7, Clause (149)

114) IMDA may notify in the regulations, mandatory registration of

certain devices falling under the group in Class A, which are normally

exempt from registration. However, reasons for such inclusion shall be

provided in the notification.

115) IMDA shall create and maintain a REGISTER of medical devices

placed on the Indian market and notify in the Regulations, the

information that is needed for completing the registration.

116) The information required may vary depending on the device

classification and the location of the manufacturer.

117) IMDA shall review the registration information submitted, verify the

legal status of the manufacturer and the Authorised Representative

and issue a UNIQUE REGISTRATION NUMBER within the stipulated

time limits specified under Clause (119)

118) The manufacturer may place the medical device on the Indian

market after completion of the Registration with IMDA. In doing so, he

shall comply with the requirements for MARKING as specified in

Registration,

Marking and

placing the

device on the

market

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Chapter 7, Clause (149)

BB 119) IMDA shall make all necessary arrangements and ensure that

Registrations are completed as speedily as possible. To ensure that

there are no undue delays in Registration, the following maximum timelimits

from the date of application shall apply:

a) Class A devices – 30 days

b) Class B devices – 45 days

c) Class C & D devices – 90 days

120) In case IMDA does not respond to applications for registration

within the time limits in writing, it shall be deemed that the registration

has been completed and the manufacturer can place the device on the

market with reference to the application number and date.

121) In cases, where the registration information submitted is not

complete or is incorrect or does not meet the requirements of this Act

in anyway, IMDA shall give notice to the manufacturer or the

Authorised Representative of such shortcomings in writing, within the

stipulated time-limit.

122) These time limits shall again apply from the date of re-submission

of the registration information for further action by IMDA.

123) In cases of undue delay due to repeated dissatisfaction of IMDA

with the information submitted, and if deemed unjustified, the

manufacturer may seek suitable remedy by approaching the MDSA

Tribunal.

Time limits for

completion of

Registration by

IMDA

BC 124) Manufacturers shall maintain records of manufacture, sale and

other necessary information of their medical devices as notified in the

regulations. These may relate to:

a) Date of manufacture, sale, expiry, batch numbers, date of release

and other relevant information;

b) Custody, intended purpose, supply, disposal or destruction of

devices;

c) Keeping of records relating to devices, including records relating to

the tracking and location of devices after their supply;

d) Such other matters and information as deemed appropriate so as

to enable the recall of devices from the market, if necessary.

125) Registration of medical devices is subject to a condition that

advertising material relating to the medical devices is consistent with

the intended purpose as certified in the Declaration of conformity and

follows the code of advertising as notified in the regulations by IMDA.

Records of

manufacture

and tracking of

devices

Code of

advertising

BD 126) Registration of a medical device is also subject to the condition

that, manufacturers shall allow the officers, employees or authorized

representatives of IMDA to carry out necessary inspections at

reasonable times, all premises associated with the manufacture of that

device, whether in India or outside India, and also to supply it with all

relevant information, and in particular:

a) The summary technical documentation and the Declaration of

conformity;

Obligation of

manufacturers

to allow

inspection of

their premises

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b) the documentation on the quality system,

c) the data stipulated relating to quality assurance, safety testing &

evaluation, calibration data, qualification reports of the personnel

concerned, results of analyses, calculation tests, etc.,

d) supply samples if asked if required; where the cost of samples are

high, such request shall be under the orders of the CEO, subject to

such demands being reasonable in terms of total costs;

e) carry out tests or allow tests to be carried out on the device;

f) permit copies of documentation to be made.

CHAPTER 7: CONFORMITY ASSESSMENT PROCEDURES, DEVICE

MARKING AND NOTIFIED BODIES

BE 127) IMDA shall notify through the regulations, the requirements relating

to conformity assessment and the application of Quality Management

Systems (QMS) for medical devices, and other requirements to be met

by the manufacturers.

128) The conformity assessment procedures, or any part of the

conformity assessment procedures prescribed by the IMDA, may:

a) be limited in their application to one or more medical device

classifications; or

b) apply differently to different medical device classifications.

129) Without limiting clause (127), the regulations may relate to all or

any of the following:

a) application of Quality Management Systems (QMS) for the

manufacture of medical devices;

b) declaration of conformity with the essential principles, or the quality

management systems for the manufacture of medical devices;

c) notification of, and assessment of, changes to a manufacturer’s

product range, product design or quality management systems;

iii) declarations to be made by manufacturers of medical devices that

conformity assessment procedures have been applied to the

devices;

iv) marks to be affixed to medical devices indicating the application of

the conformity assessment procedures to the devices;

v) monitoring and inspecting the design of medical devices or the

manufacturing processes for medical devices;

vi) monitoring the performance of medical devices;

vii) corrective action required in relation to the design, manufacture,

packaging, labelling and supply of medical devices;

viii) Keeping records of the manufacture of medical devices, the design

of medical devices or the manufacturing processes for medical

devices.

130) The basic elements of conformity assessment procedures shall be

based on the following principles:

Conformity

assessment

procedures

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a) In the case of Class A medical devices,

i) Establish and maintain a full QMS or a “QMS without design

and development controls”.

ii) Audit by a Notified Body is not required except in those

devices, which have a measuring function or those, which are

required to be sterile or in other special cases.

iii) Establish and maintain an adverse event reporting procedure

as specified in the regulations by IMDA

iv) Prepare a Summary Technical Document, which shall be

available for review by IMDA, whenever requested.

v) Prepare, sign and maintain the Declaration of conformity.

b) In the case of Class B medical devices,

i) Establish and maintain a full QMS or a “QMS without design

and development controls”.

ii) The manufacturing system shall be audited by a Notified Body

to verify that an appropriate QMS is in place.

iii) Establish and maintain an adverse event reporting procedure

as specified in the regulations by IMDA; this system shall be

audited and verified by the Notified Body.

iv) Prepare a Summary Technical Document, which shall be

available for review by the Notified Body or IMDA, when

required.

v) Prepare, sign and maintain the Declaration of conformity,

which shall also be verified by the Notified Body.

c) In the case of Class C medical devices,

i) Establish and maintain a full QMS.

ii) The manufacturing system shall be audited by a Notified Body

to verify that an appropriate QMS is in place.

iii) Establish and maintain an adverse event reporting procedure

as specified in the regulations by IMDA; this system shall be

audited and verified by the Notified Body.

iv) Prepare a Summary Technical Document, which shall be

reviewed by the Notified Body in the premarket phase to

determine conformity to Essential Principles.

v) Prepare, sign and maintain the Declaration of conformity,

which shall also be verified by the Notified Body.

d) In the case of Class D medical devices,

i) Establish and maintain a full QMS.

ii) The manufacturing system shall be audited by a Notified Body

to verify that an appropriate QMS is in place.

iii) Establish and maintain an adverse event reporting procedure

as specified in the regulations by IMDA; this system shall be

audited and verified by the Notified Body.

iv) Prepare a Summary Technical Document, which shall be

reviewed by the Notified Body in the premarket phase to

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determine conformity to Essential Principles.

v) Prepare, sign and maintain the Declaration of conformity,

which shall also be verified by the Notified Body.

e) In the case of custom-made devices, the manufacturer shall follow

the procedure prescribed in the regulations and draw up the

declaration of conformity before placing such device on the market

131) Except where not required as per the regulations, manufacturers

shall select a suitable Notified Body, who is authorized for the particular

class of device, to carry out conformity assessment as per the

requirement of this Act.

132) The Notified Body shall audit, evaluate all the necessary

documentation, test sample devices (if necessary) and carry out other

inspections as required under this Act and specified in the regulations

by IMDA, and verify that the manufacturer meets the requirements of

this Act.

133) The decisions taken by the Notified Bodies with respect to the audit

and verification of conformity assessment shall be valid for a specified

period as stipulated in the regulations and may be extended on

application.

134) The records and correspondence relating to the conformity

assessment shall be in English.

135) The IMDA may, in exceptional cases and for sufficient reasons to

be recorded in writing, authorize, temporarily and for a stated period,

the placing on the market and putting into service of particular devices

for which conformity assessment procedures stated in this chapter

have not been complied with, if such a course is necessary to meet an

emergency and / or in the interest of public health and its protection.

136) During the conformity assessment verification, the Notified Body

may, in appropriate cases, take account of the data or results of any

testing, assessment or verification operations, which, have been

carried out at an earlier or intermediate stage of product development

of a medical device.

137) The IMDA or the Notified Body may exempt the manufacturer from

making a complete premarket submission and/or require a less

rigorous audit than would apply normally to a device of that risk class,

when

a) that device is substantially equivalent if, in comparison to a

predicate device, it:

i) has the same intended use as the predicate; and has the same

technological characteristics as the predicate; or

ii) has the same intended use as the predicate, has different

technological characteristics and the information submitted

does not raise new questions of safety and effectiveness. The

information clearly demonstrates that the device is at least as

safe and effective as the legally marketed device.

NOTE: A claim of substantial equivalence does not mean the new and

predicate devices must be identical. Substantial equivalence is established

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 34 of 49

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with respect to intended use, design, energy used or delivered, materials,

chemical composition, manufacturing process, performance, safety,

effectiveness, labeling, biocompatibility, standards, and other

characteristics, as applicable.

138) IMDA or the Notified Body may require more detailed premarket

submission and/or require a more rigorous audit and/or the provision of

more clinical evidence than would apply normally to a device of that

risk class when:

a) the device incorporates innovative technology;

b) an existing compliant device is being used for a new intended use;

c) the device is new to the manufacturer;

d) the device type tends to be associated with an excessive number

of adverse events, including user errors;

e) the device incorporates innovative or potentially hazardous

materials;

f) the device type raises specific public health concerns.

139) Exemptions given as per Clauses (137) or additional requirements

sought under Clause (138) shall be fully justified and documented

before IMDA or the Notified Body modifies in any way the relationship

between device class and the associated conformity assessment

element for that particular device. Where there is justification for

variation to the conformity assessment elements normally applicable to

a particular device class, a statement to that effect shall be included in

the technical documentation.

140) IMDA shall specify in the regulations, the requirements for

conformity assessment for custom medical devices and the procedure

relating to medical devices for clinical investigations.

BK 141) Confirmation of conformity with the requirements concerning the

safety and performances of a medical device under the normal

conditions of use and the assessment of risks associated with the

device, must be based on the results of scientifically conducted clinical

investigations. For implantable devices and devices in Class C and

Class D, this shall be considered essential, unless notified otherwise by

IMDA.

142) The Clinical evaluation, while taking into account appropriate

standards, must be based on:

i) either a compilation of the relevant scientific literature currently

available with reference to the intended purpose of the device and

the techniques employed as well as, if appropriate, a written report

containing a critical evaluation of this compilation;

ii) or the results of all the clinical investigations made, including those

carried out in conformity with the guidelines given in the

regulations.

143) In the case of devices intended for clinical investigations, the

manufacturer, or his authorized representative shall follow the

requirements and guidelines for clinical investigations as laid down in

Clinical

investigation

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the regulations by IMDA.

144) IMDA shall review the applications taking into account the benefits

& risks, and authorize manufacturers to commence the clinical

investigations before the expiry of the period of 60 days, in so far as

the relevant ethics committee has issued an approval for the

investigation in question.

145) The manufacturer, who has the approval of the relevant ethics

committee, may commence the clinical investigation at the end of 90

days after submission of application, unless IMDA has notified him

within that period, of a decision to the contrary.

BG 146) The Notified Body on completion of the audits and verification

procedures shall issue a CONFORMITY ASSESSMENT

CERTIFICATE to the manufacturer as per the prescribed format in the

regulations applicable to that device class.

147) A conformity assessment certificate is subject to the conditions that

the manufacturer in respect of whom the certificate is issued will:

a) Allow an authorised person of the Notified Body

i) to enter, the premises (including premises outside India) at

any reasonable time at which the manufacturer deals with

medical devices covered by the certificate; and

ii) while on those premises, to inspect the entire premises and

medical devices found therein and to take samples thereof;

iii) to carry out tests, or require tests to be carried out on the

medical devices; and

b) If requested to do so by an authorised person of the Notified Body:

i) produce to the person such documents and technical

information relating to devices, or to the manufacturer’s quality

management system, as the person requires; and

ii) Provide copies or extracts of documents as requested by the

person

Conformity

Assessment

Certificate.

Entry,

inspection and

taking of

samples, etc

BG 148) IMDA shall prescribe in the regulations, a method to be adopted for

identification of medical devices that conform to the requirements of the

Act. The medical devices placed on the market should bear an

identification mark and / or the registration number or any other

inscription or method specified in the regulations, to indicate their

conformity with the provisions of this Act.

149) The manufacturer shall affix the Identification Mark as specified in

the regulations on all packaging and accompanying information, user

instructions, and the like, before placing the device on the market.

150) It shall be ensured by the manufacturer and / or his representatives

that no medical device, label, packaging material or user manual of a

medical device should carry any mark, inscription or number

misleadingly similar to the conformity identification mark.

Marking of

conforming

medical devices

BH 151) IMDA shall lay down the procedure to be adopted for qualification

and selection of notified bodies to carry out Conformity Assessment as

per this Act with the assistance of its Advisory Committee. The

Notified Body

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Advisory committee shall consider and adopt the criteria and

requirements laid down in national or international standards for this

purpose.

152) Notified Bodies shall be accredited by the National Accreditation

Board for Certification Bodies or other similar bodies notified for the

purpose under the regulations by IMDA.

153) Notified Bodies shall be subject to regular performance audits, at

least once in two years, by IMDA or its representatives, as specified in

the regulations. It shall also be open to IMDA to witness the conformity

assessment carried out by a notified body.

154) The recognition of Notified Bodies will be for a definite period of

time and renewable as envisaged in the regulations.

155) It shall be open to IMDA to revoke and withdraw the recognition of

a notified body at any time, if it finds that the notified body no longer

meets the prescribed criteria for performance. IMDA shall also ensure

that all affected parties are promptly informed of this decision.

156) When selecting a Notified Body, IMDA shall also identify the areas

in which that body is deemed competent to carry out conformity

assessment. A unique identification number shall be issued to the

Notified Body by the IMDA.

157) The list of notified bodies and changes there to, made

subsequently shall be notified in the Gazette of India regularly.

158) IMDA shall treat all Notified Bodies on a par with each other and

will give fair and equal treatment to them.

159) The manufacturers shall be at liberty to select any Notified Body,

competent to perform conformity assessment verification in its area of

operation and the particular device class.

160) The manufacturers shall have the opportunity to report any

grievance or complaint on the functioning of a Notified Body to IMDA,

which shall be dealt with by IMDA in accordance with the regulations

framed for the purpose.

161) The notified body and the manufacturer, or his authorized

representative established in the country, shall lay down, by common

accord, the time limits for completion of the conformity assessment.

BJ 162) IMDA shall in the regulations specify the period for which records

of the Notified Bodies shall be retained. While doing so, modern

methods including electronic documentation may also be borne in

mind.

Records of

Notified Bodies

BK 163) Notified Bodies or members of their staff who have been shown to

have

i) colluded with the manufacturer or

ii) been wilfully or grossly negligent

in the performance of their duties related to Conformity assessment

resulting in the placing of unsafe medical devices in the market or

devices which do not meet the Essential requirements of this Act are

liable to be considered an “ABETTOR” and penalised or prosecuted as

Offences of

Notified Bodies

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per the provisions under Chapter 13, along with the manufacturer

concerned.

CHAPTER 8: EXPORT OF MEDICAL DEVICES FROM INDIA

BL 164) Manufacturers shall ensure that any medical device

MANUFACTURED IN INDIA and EXPORTED meets the requirements of

this Act and are registered with IMDA.

165) At the request of a manufacturer located in India or his Authorised

Representative, IMDA shall issue a CERTIFICATE of compliance with the

requirements of this Act for a device registered with it.

166) IMDA may exempt manufacturers of devices, which are solely

intended for Export from India, from the obligations under this Act, for

specific reasons, which shall be clearly documented. Such reasons shall

normally be limited to the following conditions:

a) The devices are being exported to a country having similar

requirements or a well-established regulatory system, which ensures

their safety before being placed on their market.

b) For mitigation of natural disasters or calamities in the target country.

c) Orders of the Central Government to assist the target country.

167) Exemptions under Clause (166) shall NOT be normally given when

the devices being exported can be sold or re-exported to countries which

DO NOT have a well established regulatory mechanism than can ensure

that the devices are safe.

Export of

Medical

Devices

CHAPTER 9: REFURBISHED / DATE EXPIRED MEDICAL DEVICES

BM 168) IMDA shall make and publish regulations governing the use of

refurbished medical devices whether imported or otherwise, to ensure that

the safety of the patient and or user and other persons is not

compromised.

169) IMDA shall also make and publish regulations governing the

conditions for use of date expired medical devices whether imported or

otherwise, and providing for penalties for contravention of the specification

given by manufacturer, to ensure that the safety of the patient and other

persons is not compromised.

Conditions

governing use

of Refurbished/

Date expired

medical devices

Chapter 10: VIGILANCE AND REPORTING OF ADVERSE EVENTS

BN 170) IMDA shall, through regulations, prescribe the procedures and

methods to obtain information from the manufacturer/ hospitals,

healthcare delivery professionals and users on any adverse

events/incidents related to the use of medical devices and take

appropriate precautionary/preventive measures as it may deem fit to

Vigilance by

IMDA on

Adverse events

and unsafe

devices

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minimise the risks and hazards associated with its use.

171) Such regulations may provide for mandatory reporting by the

manufacturers, voluntary reporting by users or other interested persons or

organizations of such events, and steps to be taken based on such

information.

172) IMDA shall set up suitable systems, reporting formats and notify time

limits for reporting.

173) IMDA shall also notify who are identified personnel / departments

where such reports shall be filed by the manufacturers, healthcare

professionals and the public.

174) IMDA shall preferably set up electronic databases and websites to

enable easy reporting of these adverse events followed by analysis and

speedy corrective action.

175) When IMDA ascertains that certain devices when correctly installed,

maintained and used for their intended purpose, may compromise the

health and/or safety of patients, users or, where applicable, other persons,

it shall take all appropriate measures to withdraw such devices from the

market or prohibit or restrict their being placed on the market or put into

service.

176) When any malfunction or deterioration in the characteristics and/or

performance of a device, as well as any inadequacy in the labelling or the

instructions for use which might lead to or might have led to the death of a

patient or user or to a serious deterioration in his state of health, the such

measure may include:

i) directing manufacturer to suspend sales and / or to systematically

recall all devices of the same type from the market;

ii) directing manufacturers to advise all clinicians about the possible

hazard and the suitable actions to be taken by them regarding

patients who may be at risk;

iii) issue direct public notices of such hazards, if warranted;

iv) seize or confiscate hazardous devices if deemed necessary to protect

the public;

v) other emergent actions deemed necessary and essential.

177) IMDA shall also analyse the reasons as to how such unsafe devices

were placed on the market and especially whether it was due to:

i) failure to meet the essential requirements;

ii) incorrect application of the standards referred, in so far as it is claimed

that the standards have been applied;

iii) shortcomings in the standards themselves

IMDA shall use such information to ensure prevention of such unsafe

devices reaching the market in the future.

BO 178) IMDA shall set up systems and issue regulations to monitor the labels,

user instructions, advertisements, web sites and other printed and

electronic material related to all medical devices and ensure that:

i) they are clear, unambiguous and are not misleading

ii) they do not make any claims, especially of efficacy which are not

Vigilance on

advertising and

sales promotion

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documented in the STED and stated in the Declaration of conformity

iii) they do not make claims for use of the device for clinical indications,

for which the device has not been registered with IMDA

iv) they do not mislead the clinical professional or the public to use the

device in such a manner that it may increase the risk and be a

potential hazard leading to death or serious injury and

v) they do not include unnecessary information.

179) The monitoring as described above may also cover all sales and

promotional actions of the manufacturer including:

i) Exhibitions, seminars, conferences, etc.

ii) Sales talks / video presentations given by their representatives to

medical professionals

iii) And any other actions of the manufacturer to promote the sale of the

device.

CHAPTER 11: ENFORCEMENT OF THIS ACT

BQ 180) IMDA shall be the agency primarily responsible for the enforcement of

this Act.

181) IMDA shall monitor, verify and ensure that medical device

manufacturers fulfill the relevant requirements of this Act, at all stages of

medical device business.

182) IMDA shall appoint officers for efficient and effective implementation

of this Act, who shall have following functions namely to :

i) Disseminate information and build awareness amongst the various

stakeholders such as medical device manufacturers, medical

practitioners and health care professionals, vendors, users etc.

ii) Conduct or organize training programme for personnel

iii) carry out survey of the manufacturers to find out the compliance with

the provisions of this Act

iv) carry out surveillance of the notified bodies including regular

performance audits as indicated in Chapter 7, Clause (153)

v) coordinate and interact with other regulatory bodies and

vi) ensure a uniform and efficient implementation of the provision of this

Act.

Enforcement of

the Act

BQ 183) The officers of the IMDA may take a sample of any medical device

which appears to be intended for sale, or to have been sold, which may be

required as evidence for proceedings under any of the provisions of this

Act or of the rules, regulations or orders made there under and send the

same for analysis to a medical device testing laboratory for further

examination.

184) The taking of such samples shall take into consideration their value

and the officer of IMDA in the case of high value devices shall give a

written note giving reasons for their need to the manufacturer.

Samples for

testing.

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185) In the case of high value devices, these actions shall be appealable, if

deemed unjust by the manufacturer.

BR 186) The IMDA may notify laboratories and research institutions preferably

accredited by National Accreditation Board for Testing and Calibration

Laboratories, National GLP Authority or any other equivalent accreditation

agency for the purposes of evaluation of medical devices under this Act.

187) Such notification shall clearly specify the devices or the class of

devices, for which the laboratory or institution is authorised to evaluate.

188) The IMDA may frame regulations specifyingi)

the functions of medical device ;

ii) the procedure for submission to the said laboratory of samples of

medical devices for analysis or tests, and

iii) such other matters as may be necessary or expedient to enable the

said laboratory to carry out its functions effectively.

Medical Device

Testing

Laboratories

BS 189) Officers of the IMDA shall report to the CEO of any violations by

manufacturers or others or any other matter that requires the intervention

of the IMDA for the effective implementation of this Act.

190) When the CEO is convinced, based on the report of the Officers of

IMDA or otherwise, regarding violations of the provisions of this Act and

the rules and regulations there under, he shall,

i) direct the manufacturer, in writing, to end the infringement or comply

with the conditions or directions imposed by IMDA, which may include

recalling/withdraw medical devices from the market, when convinced

of the need to ensure public safety.

ii) afford an effective opportunity to the manufacturer or affected party to

be heard;

191) In the case of non-compliance with such directives, the CEO may take

all appropriate measures to restrict or prohibit the placing on the market of

the medical device in question and for the purpose the CEO may direct

any subordinate officer to seek the lawful assistance of the District

Magistrate, police or other appropriate authorities including public

servants.

192) CEO of IMDA may impose financial penalties up to the maximum as

provided for under Chapter 13 with respect to the offences indicated

therein.

193) Any decision taken by IMDA pursuant to this Act:

i) to refuse or restrict the placing on the market or the putting into

service of a medical device or the carrying out of clinical

investigations; or

ii) to withdraw medical devices from the market, or

iii) to impose financial penalties

shall state the exact grounds on which it is based. Such decisions shall be

communicated in wiring to the party concerned within four weeks. Such

communication shall also convey information about the remedies and

avenues for challenge available to him under the Act including the time

limits concerned.

Violations and

financial

penalties

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194) Any decision taken by IMDA pursuant to this Act to refuse or restrict

the placing on the market or the putting into service of a device or the

carrying out of clinical investigations or to withdraw devices from the

market shall be appealable.

BT 195) It shall be lawful for an AUTHORISED OFFICER OF IMDA, and

assisted by any police officer not below the rank of a Sub Inspector of

police of a police station which has received a complaint from the CEO of

IMDA relating to an offence under this Act:

i) To enter, if necessary, by force, whether by day or night and with such

assistance as he considers necessary, any premises which he has

reason to suspect, are being used for purposes connected with the

commission of the offence;

ii) To search the said premises;

iii) To take into custody and produce before any Judicial magistrate all

such persons against whom the offence is alleged or against whom a

complaint has been made or credible information has been received

or a reasonable suspicion exists of their having a been concerned

with the use of the said premises for purposes connected with the

offence; and

iv) To seize, all things, equipments and relevant records found in the said

premises which are intended to be used, or reasonably suspected to

have been used, in connection with the offence in question.

196) Any officer authorized under this Act or under the Rules framed under

this Act may,

i) at all reasonable times, enter into and search any premises which he

has reason to suspect, are being used for the purposes connected

with the commission of an offence under the Act or the Rules,

ii) Examine any person having the control of, or employed in connection

with, any such offence;

iii) Order the production of any documents, books or records in the

possession of such person and relating to the offence alleged against

him, and

iv) Inspect and seize any register, books of accounts, documents or any

other literature found in the said premises.

197) All searches under this section shall be made in accordance with the

procedure prescribed under the code of Criminal Procedure, 1973.

Power to enter,

search and

seize

BU 198) No prosecution for an offence under this Act shall be instituted except

by or with the written consent of the CEO of IMDA.

199) Notwithstanding anything contained in the Code of Criminal

Procedure, 1973 an offence, punishable under this Act shall be NONCOGNIZABLE

and NON-BAILABLE.

200) No Court inferior to that of Metropolitan Magistrate or a Judicial

Magistrate of the first class shall be competent to try any offence under

this Act

201) No prosecution for an offence under the Act shall be instituted in

respect of the same facts on which a penalty has been imposed under this

Cognizance of

offences and

procedure for

trial

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section on compounding the offence.

CHAPTER 12: MEDICAL DEVICE SAFETY APPELLATE TRIBUNAL

BV 202) The Central Government, by notification, shall establish one or more

tribunals to be known as the Medical Device Safety Appellate Tribunal

(MDSA) to hear appeals from the decisions of the IMDA.

203) The Presiding Officer of the MDSA Tribunal shall be appointed by the

Central Government by notification in the Central Gazette. It shall be a

single member Tribunal. No person shall be qualified for appointment as

a Tribunal unless he is or has been a Judge of a High Court.

204) The term of office, salary and allowances, resignation and removal of

the Tribunal shall be prescribed by the Central Government.

205) The procedure of appeal and powers of the Tribunal shall be such as

may be prescribed by the rules. The Tribunal shall not be bound by the

procedure laid down by the Code of Civil Procedure, 1908; but shall be

guided by the principles of equity, justice and good conscience. Subject to

the other provisions of this Act and the rules made there under, the

Tribunal shall have powers to regulate its own procedure including the

place at which it shall have its sittings.

Establishment

of Medical

Device Safety

Appellate

Tribunal

BW 206) The Tribunal shall have, for the purposes of discharging its functions

under this Act, the same powers as are vested in a civil court under the

Code of Civil Procedure, 1908, while trying a suit, in respect of the

following matters, namely:-

i) summoning and enforcing the attendance of any person and

examining him under oath;

ii) requiring the discovery and production of documents or other

electronic records;

iii) receiving evidence on affidavits;

iv) issuing commissions for the examination of witnesses or documents;

v) reviewing its decisions;

vi) dismissing an application for default or deciding the case ex-parte;

vii) any other power which may be conferred by the Central Government

through appropriate notification.

207) Every proceeding before the Tribunal shall be deemed to be a judicial

proceeding within the meaning of sections 193, 228, and 196 of the

Indian Penal Code and it shall be deemed to be a civil court for the

purposes of section 195 and Chapter XXVI of the Code of Criminal

Procedure, 1973.

208) In proceedings before the Tribunal, the appellant may either appear

in person or authorize any of his/its officers or one or more legal

practitioners to represent his/its case before the Tribunal.

209) The provisions of the Limitation Act, 1963, shall, except as otherwise

provided in this Act, apply to an appeal made to the Tribunal.

Procedure and

Powers of

Tribunal

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210) Subject to judicial review before the Supreme Court or High Court,

the decision of the Tribunal shall be final.

CHAPTER 13: OFFENCES AND PENALTIES

BX 211) The government shall notify in the rules, the amount of fines / financial

penalties to be levied for the various offences listed in this chapter below.

Notification of

fines in rules

BY 212) Any person who manufactures, makes available for sale, or sells to

the purchaser's prejudice any medical device, which is not in compliance

with the provisions of this Act or the regulations made there under, shall

be punished with a fine as notified or with rigorous imprisonment which

may extend to one year or both.

Penalty for

medical device

that does not

conform to this

Act

BZ 213) Whoever, by himself or through any other person on his behalf,

manufactures or makes available for sale or stores or sells or distributes

or imports any medical device which is misbranded as per the definitions

and provisions of this Act or under regulations framed there under shall

be punished with a fine as notified or with rigorous imprisonment which

may extend to 6 months or both.

Penalty for a

misbranded

medical device

CA 214) Any person who willfully tampers with any medical device, package or

labelling with malafide or criminal intentions or for commercial or financial

motives and places the same on the market jeopardizing the safety of the

users, patients or others shall be punishable with rigorous imprisonment

for a term which may extend to six months or with a fine as notified or

both.

Penalty for

tampering with

a medical

device

CB 215) If a medical device manufacturer or his authorized representative,

without reasonable ground, fails to comply with the requirements of this

Act or the regulations or orders issued there under, as directed by the

IMDA or its officers, he shall be punished with a fine as notified or with

rigorous imprisonment which may extend to one year or both.

Penalty for

failure to

comply with the

directions of the

IMDA etc.

CC 216) Whoever, bound under this Act or the Rules or Regulations framed

hereunder to provide information to an authority under this Act, fails to

furnish or furnishes / produces information which he knows is false or

misleading, shall be punished with imprisonment of either direction for a

term which may extend to three months or with fine as notified.

Punishment for

false

information or

failure to

provide

information

CD 217) Whoever, bound under the Act to register his product with the IMDA,

manufactures, imports, sells, stores, or distributes any medical device

without such registration shall be punishable with rigorous imprisonment

for a term which may extend to six months or with fine as notified.

Punishment for

carrying out

business

without

registration

CE 218) Whoever retains removes or tampers with any medical device,

package or labelling or advertising material or other thing that has been

seized under this Act, without the permission of IMDA or its officers shall

be punishable with rigorous imprisonment for a term which may extend to

six months or with fine as notified.

Punishment for

Interfering with

seized items

CF 219) Whoever, without reasonable excuse, resists, obstructs, or attempts Punishment for

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to obstruct, threaten, intimidate or assault an officer of the IMDA in

exercising his functions under this Act, shall be punishable with

imprisonment for a term which may extend to six months or with fine as

notified.

obstructing a

IMDA officer

CG 220) If any person who has been convicted of the commission of, or

attempt to commit, or abetment of, or criminal conspiracy to commit, any

of the offences punishable under this Act is subsequently convicted of the

commission of, or attempt to commit, or abetment of, or criminal

conspiracy to commit, an offence punishable under this Act with the same

amount of punishment shall be punished for the second and every

subsequent offence with rigorous imprisonment for a term which shall not

be less than one-half of the maximum term of imprisonment, and also be

liable to fine which shall extend to one-half of the maximum amount of fine

prescribed for the offence.

221) Where a competent court of criminal jurisdiction outside India convicts

any person under any corresponding law, such person shall be dealt with

for the purposes of Clause (220) as if a court in India had convicted him.

222) The Court may, in appropriate cases cause the offender's name,

place of residence, the offence and the penalty imposed, to be published

at his own expense in specified newspapers or in such other manner as

the court may direct and the expenses of such publication, in case of non

payment, shall be recoverable in the same manner as if it were a fine

imposed by Court.

Punishment for

subsequent

offenses

CH 223) Any person who imports into India any medical device in

contravention of the provisions of this Act, or rules or regulations made

there under, shall, in addition to any penalty to which he may be liable

under the provisions of the Foreign Trade (Development and Regulation)

Act 22, 1992 and the Customs Act 52, 1962 be also liable for punishment

under this Act.

224) It shall be competent for the convicting Court or any higher court to

which the case may be taken to, to direct that any particular medical

device involved in the case shall be confiscated and destroyed

irrespective of any order for return passed by any other authority under

the Foreign Trade (Development and Regulation) Act 22,1992 or the

Customs Act 52, 1962, or any other enactment.

Penalty for

contravention of

provisions of

this Act in case

of import of

medical devices

to be in addition

to penalties

provided under

any other Act.

CI 225) Where any person has been convicted under this Act for the

contravention of any of the provisions of this Act or of any Rule there

under, it will be open to the court of conviction or any superior Court to

which the case might be taken to, to order that the stock of the defective

medical device concerned and the illegal gains made by the offender by

contravention of the provision concerned may be forfeited to the

Government. Provided that where the Court is satisfied that the device is

capable of being made to conform to prescribed standards for

consumption after reprocessing or modification, and there is reasonable

possibility of rectification through such reprocessing/modification, the

Court may order the stock of device concerned to be returned to the

manufacturer or other person from whom it was seized, as the case may

be, on his executing a bond with or without sureties, on undertaking that

Forfeiture of

property

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the stock or any part thereof would not be sold or made available for

consumption to the public or any other consumer without the necessary re

processing/modification carried out under the supervision of an authorized

officer named in the Rules framed under this Act.

CJ 226) Where a person committing a contravention of any of the provisions of

this Act or of any rule, direction or order made there under is a company,

every person who, at the time the contravention was committed, was in

charge of, and was responsible to the company, for the conduct of the

business of the company as well as the company, shall be deemed to be

guilty of the contravention and shall be liable to be proceeded against and

punished accordingly. Provided that nothing containing in this clause shall

render any such person liable to punishment if he proves that the

contravention took place without his knowledge or that he exercised all

due diligence to prevent such contravention.

227) Notwithstanding anything contained in Clause ( 226), where a

contravention of any of the provisions of this Act or of any rule, direction or

order made there under has been committed by a company and it is

proved that the contravention has taken place with the consent or

connivance of, or is attributable to any neglect on the part of any director,

manager, secretary or other officer of any company, such director,

manager, secretary or other officer shall also be deemed to be guilty of

the contravention and shall be liable to be proceeded against and

punished accordingly.

228) Notwithstanding anything contained in the Clauses ( 226) & ( 227), the

person or the Authorised Representative who has signed the Declaration

of Conformity shall be deemed to be guilty of the contravention under this

Act at all times.

Explanation.-For the purposes of this section,-

(i) "company" means any body corporate and includes a firm or other

association of individuals; and

(ii) "director", in relation to a firm, includes a partner in the firm.

Offences by

companies

CK 229) No suit shall be brought in any civil court to set aside or modify any

proceeding taken or order made under this Act and no prosecution, suit or

other proceeding shall lie against the Government or IMDA or any of their

officers for anything done or intended to be done in good faith under this

Act.

Bar of suits in

civil courts

CL 230) The CEO of the IMDA may accept from any person against whom a

reasonable suspicion exists that he has committed any offence under the

Act a sum of money, not exceeding the maximum fine prescribed for the

offence concerned, and compound the offence which such person is

suspected to have committed, and When any property has been seized as

liable to confiscation, release the same to the person from whom the

seizure was effected on payment of the penalty aforementioned. The

decisions of the CEO in such compounding shall be promptly informed to

the IMDA for ratification.

231) On payment of such penalty, the suspected person, if in custody, shall

Power to

compound

offences

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be discharged and the property, if any, seized shall be released, and no

further proceedings shall be taken against such person or property;

provided that such composition can be done, if charge is already laid by

the Police before Court on completion of investigation, or an appeal is

pending before the MDSA only with the permission of the Court/MDSA as

the case may be.

CHAPTER 14: FINANCE, ACCOUNTS AND REPORTS OF IMDA

CM 232) The IMDA shall prepare, in such form and at such time in each

financial year as may be prescribed by the Central Government, its budget

for the next financial year, showing the estimated receipts and expenditure

of the IMDA and forward the same to the Central Government.

233) The IMDA with the prior approval of the Central Government shall

adopt financial regulation, specifying, in particular, the procedure for

drawing up and implementing the Authority's budget.

Budget of IMDA

CN 234) The Central Government may, after due appropriation processes,

make over to the IMDA grants of such sums of money as the Central

Government may think fit.

235) The IMDA on the recommendation of the Advisory Committee shall

notify a fee structure for its various services like the following: -

a) Registration of a medical device, verification of the legal status of an

Authorised Representative and other services to a manufacturer.

b) Registration and notification of Notified Body; audit and assessment /

reassessment of Notified body; witnessing of a manufacturer’s

conformity assessment by a Notified Body, etc.

Finances of

IMDA and

notification

/collection of

fees

CO 236) Notwithstanding anything contained in the Wealth-tax Act, 1957, the

Income Tax Act, 1961, or any other enactment for the time being in force

relating to tax on wealth, income, profits or gains, the Authority shall not

be liable to pay wealth-tax, income tax, service tax or any other tax in

respect of their wealth, income, profits or gains derived.

Exemption from

tax on wealth,

income and

service tax.

CP 237) The IMDA shall maintain proper accounts and relevant records as

may be prescribed by rules and prepare an annual statement of accounts

in such form as may be prescribed by the Central Government in

consultation with the Comptroller and Auditor General of India

238) The Comptroller and Auditor-General and any person appointed by

him in connection with the audit of the accounts of the IMDA under this

Act shall have the same rights and privileges and authority in connection

with such audit as the Comptroller and Auditor General generally has in

connection with the audit of Government accounts and, in particular, shall

have the right to demand the production of books, accounts, connected

vouchers and other documents and papers and to inspect any of the

offices of the IMDA for these purposes.

239) The accounts of the IMDA, as certified by the Comptroller and Auditor

General or any other person appointed by him in this behalf, together with

the audit report thereon shall be forwarded annually to the Central

Government by the IMDA and the Central Government shall cause the

Accounts and

Audits of IMDA

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audit report to be laid, as soon as may be after it is received, before each

House of Parliament.

CQ 240) The IMDA shall prepare once every year, in such form and at such

time as may be prescribed by the central Government, an annual report

giving a summary of its activities during the previous year and copies of

the report shall be forwarded to the Central Government.

241) A copy of the annual report received under the above provision shall

be laid, as soon as may be after it is received, before each House of

Parliament.

Annual Report

of IMDA

CHAPTER 15: MISCELLANEOUS

CR 242) Without prejudice to the foregoing provisions of this Act, it shall be

open to the Central Government to issue directions to the IMDA with

regard to the exercise of its powers and in performance of its functions

under this Act, and the IMDA shall be bound by such directions on

questions of policy, other than those relating to technical and scientific

matters, provided that the IMDA shall, as far as practicable, be given an

opportunity to express its views before any such direction is given.

243) If any dispute arises between the Central Government and the IMDA

as to whether a question is or is not a question of policy, the decision of

the Central Government thereon shall be final.

244) The IMDA shall furnish to the Central Government such returns or

other information with respect to its activities as the Central Government

may, from time to time, require.

Power of

Central

Government to

issue directions

to IMDA and

obtain reports

CS 245) The Members and officers of the IMDA and MDSA shall be deemed,

when acting or purporting to act in pursuance of any of the provisions of

this Act, to be public servants within the meaning of section 21 of the

Indian Penal Code.

Legal status of

IMDA members

and employees

CT 246) The Central Government, after consultation with IMDA, may by

notification in the Official Gazette, make rules to carry out the purposes of

this Act;

247) Provided that consultation with IMDA shall not be necessary on the

first occasion of the making of rules under this Act;

Power to make

rules

CU 248) The IMDA may, with the prior approval of the Central Government,

make and publish through notification in the Gazette of India, regulations

consistent with this Act, to regulate its function and activities

contemplated in the Act

249) In particular, and without prejudice to the generality of the foregoing

power, and in addition to those mentioned in Clause (248), such

regulations may provide for all or any of the following matters, namely

i) salaries and other conditions of service of officers and other

employees of the IMDA;

ii) rules of procedure for transaction of business and holding of

meetings of IMDA;

iii) functions and procedures to be followed by the Advisory Committee

Power of IMDA

to make

regulations

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and Technical committees

iv) prescribing and collecting fees for conformity assessment,

registration and other services of IMDA

v) procedure to be followed to suit emergency situations in the interest

of public safety and health;

vi) the procedure and manner of marking ,labeling, advertisement and

promotion of sale of medical devices;

vii) conditions and guidelines relating to medical device withdrawal or

recall;

viii) regulations relating to functioning of Officers empowered to carry out

surveillance and vigilance

ix) notifying procedure for the registration of medical device

manufacturers

x) fees and other charges which may be demanded and received by

IMDA for the various activities required to be carried out by it under

this Act;

xi) any other matter which is required to be, or may be, specified by the

Act or the rules in respect of which provision is to be made by

regulations.

250) Notwithstanding anything contained in Clauses (248) & (249), the

first regulations under this Act shall be made by the Central

Government ; and any regulations so made may be altered or rescinded

by IMDA In exercise of its power under sub-section (248) & (249).

CV 251) Every rule and every regulation made under this Act shall as soon as

maybe, after it is made, be placed before each House of Parliament, and

if both Houses agree in making any modification in the rule or regulation,

or both Houses agree that the rule or regulation should not be made, the

rule or regulation shall thereafter have effect only in such modified form or

be of no effect, as the case may be; so, however, that any such

modification or annulment shall be without prejudice to the validity of

anything previously done under that rule or regulation.

Rules &

regulations to

be laid before

Parliament

CW 252) The Authority may, by general or special order in writing, delegate to

any member, officer of the Authority or any other person subject to such

conditions, if any, as may be specified in the order, such of its powers and

functions under this Act (except the power to compound offences, settle

disputes and to make regulations) as it may deem necessary.

Delegation

CX 253) If any difficulty arises in giving effect to the provisions of this Act, the

Central government may, by order, published in the Official Gazette,

make such provisions not inconsistent with the provisions of this Act as

may appear to be necessary for removing the difficulty;

254) Every order made under this clause shall be laid, as soon as may be

after it is made, before each House of Parliament.

Power to

remove

difficulties

CY 255) Subject to the provisions under Clause (4), provisions derogatory to

those contained herein as might be available in the Drugs and Cosmetics

Act 1940 as it stands now after amendments or in any other enactment,

Central or State shall hereby stand repealed and it is made clear that

Repeal and

saving.

MDRA-DRAFT-v45.doc / gsb/22/8/08 Page 49 of 49

Page 49 of 49

provisions of this Act shall supervene contradictory provisions, if any,

contained in any other enactment with regard to matters provided for

herein.

256) Notwithstanding such repeal, anything done or any action taken

under the said enactments shall be deemed to have been done or taken

under the corresponding provisions of this Act.

CHAPTER 16: TRANSITIONAL ARRANGEMENTS

CX 257) IMDA shall notify and specify the time deadlines and such

arrangements as necessary to enable manufacturers of medical devices

already in the market to smoothly switch over to compliance with the

provisions and requirements of this Act but not later than the date

prescribed in clause (4).

258) Such arrangements shall include permitting manufacturers with

devices already in the market to continue to market their devices while

giving them reasonable time to complete their conformity assessment as

per their device classification and formally register with IMDA before the

date prescribed in Clause (4).

259) These manufacturers shall

a) Establish and maintain a QMS as required for the device class.

b) The manufacturing system shall be audited by a Notified Body to

verify that an appropriate QMS is in place.

c) Establish and maintain an adverse event reporting procedure as

specified in the regulations by IMDA; this system shall be audited and

verified by the Notified Body.

d) Prepare, sign and maintain the Declaration of Conformity, which shall

also be verified by the Notified Body.

e) In the case of Class C and D devices, carry out a risk analysis based

on the data available including all those from clinical use, to show that

the information available clearly demonstrates safety and

effectiveness of the device.

f) and formally register with IMDA, but not later than the date prescribed

in clause (4).

260) In the cases of such devices in the market about which complaints or

reasonable doubts exist with regard to their quality, safety or efficacy,

IMDA or the Notified Body may require the application of full conformity

assessment procedures as applicable under Clause (130) for the

particular device class.

Transitional

arrangements

for existing

devices already

in the market.

Copyrights 2009. Association of Indian Medical Device Industry.