Devices

System for post-market surveillance and adverse event

Records of manufacture and tracking of devices; code of

Obligations of manufacturers to allow inspection of their

Conformity assessment certificates; entry, inspection and

THE MEDICAL DEVICES SAFETY BILL, 2008

A BILL

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.

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

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.

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’;

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

safety has several essential elements, viz.:

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;

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;

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;

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

of all medical devices.

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

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.

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

promotional materials including omissions and deficiencies

iv) a significant public health concern

v) other information becoming available like results of testing

carried out

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;

whether activities and related results comply with planned

arrangements and whether these arrangements are implemented

effectively and are suitable to achieve the objectives.

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.

hereinafter referred to as IMDA) established under this Act.

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

investigation.

in human subjects undertaken to verify the safety and/or

performance of a specific device.

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.

Notified Body certifying that a medical device manufactured by a

manufacturer conforms to the requirements of this Act.

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

the device label.

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

environment.

instrument, apparatus, equipment or system, whether used

alone or in combination; and

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;

implementation are deemed mandatory for specific devices,

procedures, manufacturing processes, quality management

systems and the like.

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:

means of in vitro examination of specimens derived from the

human body;

notified by the IMDA as competent to carry out Conformity

Assessment of Medical Devices as per the requirements of this Act

device based upon data already available, scientific literature and,

where appropriate, laboratory, animal or clinical investigations.

marketed in India by meeting the requirements of this Act.

in the regulations to be applied by medical devices manufacturers,

Notified Bodies or other organizations covered under this Act.

presumption of conformity to specific essential principles of safety

and performance and which have been notified by IMDA.

activities performed

technical documentation held or submitted for conformity

assessment purposes.

output of the quality management system, which demonstrates

compliance of a device with the Essential Principles of Safety and

Performance of Medical Devices.

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.

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.

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

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.

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.

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

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.

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

every vacancy referred to it.

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.

vacancy in the Selection Committee

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.

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

member

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

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

equivalent to that of Additional Secretary to the Government of India

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

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).

from India.

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

and specify an appropriate system for enforcing various standards

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

or other means

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

guidelines notified in the regulations

in this regard.

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.

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.

a) convening the Governing Body meetings and other committees

IMDA’s activities to the Central Government.

employees of the IMDA.

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.

d) In vitro diagnostic devices

xv) imaging,

standing technical panels shall meet with representatives of the medical

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

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

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

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.

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.

the Advisory committee before deciding on suitable action; all such

action taken shall be reported to the Governing Body .

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.

of Parliament.

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

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

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

approval or changes.

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.

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

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

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

Gazette of India.

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

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.

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.

Nomenclature and coding. Such system may preferably be in conformity

with the systems being used internationally.

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.

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.

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.

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

them in the Gazette of India under the regulations.

standards.

be deemed to satisfy the requirements for conformity to specific essential

principles of safety and performance or design and manufacturing

requirements.

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.

applicable technology while not discouraging the use of new technologies.

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.

conformity of their medical devices to the Essential Principles of safety

and performance before and after placing them on the market.

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

suitable to the particular medical device, depending on its risk

classification.

demonstrating conformity with the requirements of the essential

principles of safety and performance.

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

(Chapter 5, Clause 87)

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.

necessary, to demonstrate that the device complies with the Essential

Principles.

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

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

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

data.

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.

the above detailed documentation shall be prepared and made

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

when called for.

these Technical Documents.

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.

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

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

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

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.

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.

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.

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.

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.

DECLARATION OF CONFORMITY legally declares that the medical

device meets with all the requirements of this Act.

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).

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.

receipt with a UNIQUE APPLICATION NUMBER to the manufacturer.

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)

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.

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

information that is needed for completing the registration.

classification and the location of the manufacturer.

legal status of the manufacturer and the Authorised Representative

and issue a UNIQUE REGISTRATION NUMBER within the stipulated

time limits specified under Clause (119)

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

shall comply with the requirements for MARKING as specified in

Chapter 7, Clause (149)

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

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.

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.

of the registration information for further action by IMDA.

with the information submitted, and if deemed unjustified, the

manufacturer may seek suitable remedy by approaching the MDSA

Tribunal.

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.

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.

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;

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.

to conformity assessment and the application of Quality Management

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

by the manufacturers.

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.

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.

based on the following principles:

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

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.

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.

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.

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.

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

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.

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.

and verification of conformity assessment shall be valid for a specified

period as stipulated in the regulations and may be extended on

application.

assessment shall be in English.

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.

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.

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.

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.

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.

conformity assessment for custom medical devices and the procedure

relating to medical devices for clinical investigations.

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.

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.

manufacturer, or his authorized representative shall follow the

requirements and guidelines for clinical investigations as laid down in

the regulations by IMDA.

& 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.

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.

procedures shall issue a CONFORMITY ASSESSMENT

CERTIFICATE to the manufacturer as per the prescribed format in the

regulations applicable to that device class.

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

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.

the regulations on all packaging and accompanying information, user

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

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.

and selection of notified bodies to carry out Conformity Assessment as

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

Advisory committee shall consider and adopt the criteria and

requirements laid down in national or international standards for this

purpose.

Board for Certification Bodies or other similar bodies notified for the

purpose under the regulations by IMDA.

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.

time and renewable as envisaged in the regulations.

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.

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.

subsequently shall be notified in the Gazette of India regularly.

will give fair and equal treatment to them.

competent to perform conformity assessment verification in its area of

operation and the particular device class.

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.

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

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

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

methods including electronic documentation may also be borne in

mind.

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

per the provisions under Chapter 13, along with the manufacturer

concerned.

MANUFACTURED IN INDIA and EXPORTED meets the requirements of

this Act and are registered with IMDA.

Representative, IMDA shall issue a CERTIFICATE of compliance with the

requirements of this Act for a device registered with it.

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.

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.

refurbished medical devices whether imported or otherwise, to ensure that

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

compromised.

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.

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

minimise the risks and hazards associated with its use.

manufacturers, voluntary reporting by users or other interested persons or

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

information.

limits for reporting.

where such reports shall be filed by the manufacturers, healthcare

professionals and the public.

enable easy reporting of these adverse events followed by analysis and

speedy corrective action.

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.

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.

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.

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

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.

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.

this Act.

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

medical device business.

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.

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.

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.

deemed unjust by the manufacturer.

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.

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

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.

manufacturers or others or any other matter that requires the intervention

of the IMDA for the effective implementation of this Act.

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;

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.

provided for under Chapter 13 with respect to the offences indicated

therein.

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

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.

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.

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.

procedure prescribed under the code of Criminal Procedure, 1973.

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

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

and NON-BAILABLE.

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

this Act

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

section on compounding the offence.

tribunals to be known as the Medical Device Safety Appellate Tribunal

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

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.

the Tribunal shall be prescribed by the Central Government.

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.

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.

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.

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

practitioners to represent his/its case before the Tribunal.

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

the decision of the Tribunal shall be final.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

adopt financial regulation, specifying, in particular, the procedure for

drawing up and implementing the Authority's budget.

make over to the IMDA grants of such sums of money as the Central

Government may think fit.

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.

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.

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

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.

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

audit report to be laid, as soon as may be after it is received, before each

House of Parliament.

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.

be laid, as soon as may be after it is received, before each House of

Parliament.

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.

as to whether a question is or is not a question of policy, the decision of

the Central Government thereon shall be final.

other information with respect to its activities as the Central Government

may, from time to time, require.

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.

notification in the Official Gazette, make rules to carry out the purposes of

this Act;

first occasion of the making of rules under this Act;

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

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

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

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).

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.

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.

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;

after it is made, before each House of Parliament.

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

provisions of this Act shall supervene contradictory provisions, if any,

contained in any other enactment with regard to matters provided for

herein.

under the said enactments shall be deemed to have been done or taken

under the corresponding provisions of this Act.

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).

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).

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).

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.