DRAFT “REV.1 dt. 9April”

GUIDELINES FOR THE REGULATORS FOR ASSESSMENT OF A MEDICAL DEVICE MANUFACTURING ORGANIZATION

SCOPE

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A. To define the guidelines to be followed by the representative of regulatory body while evaluating an application for registration or granting manufacturing license and for auditing a medical device manufacturer.

The scope of assessment will mainly depend on the risk classification of the medical device being manufactured.

The following points are to be assessed:

  1. A quality management system (ISO 13485 / IS 15579) for ensuring GMP (Good Manufacturing Practices) should be in place to minimize human mistakes, to track raw material used and to track devices, to take suitable action if a malfunction is reported. Job responsibility must be defined to fix the responsibility of failure.
  2. Suitability of raw material used should be demonstrated.
  3. Suitability of packaging should be demonstrated.
  4. If sterilized, the sterilization system must be validated.
  5. Design validation in cases of class C & D products: If a design is already existing no design validation may be required, only demonstration of equivalence may suffice. In cases where the design is new or substantially modified, design validation is required by way of suitable clinical evaluation.

 

 

 

The level of regulatory controls for different classes of product would be followed as:

S. NO.

RISK CLASSIFICATION

PRODUCT

REQUIREMENTS

1

A

Catheter

-     Invasive in body orifice or stoma (not surgically)

-     Transient use

·     Manufacturer shall register with the CLAA.

·     Manufacturing license not required.

2

B

Catheter

-     Surgically invasive

-     Transient use

I. V. Cannula

- Surgically invasive

- Short term use

Scalp Vein Sets

- Surgically invasive

- Short term use

·     Manufacturer’s quality management system to be assessed and certified by a notified body.

·     The manufacturer will be registered with the CLAA on the basis of certificate from notified body.

·     Manufacturing license not required.

 

 

S. NO.

RISK CLASSIFICATION

PRODUCT

REQUIREMENTS

3

C

Intra Ocular Lenses

-     Surgically invasive

-     Long term use

-     Implantable devices

Bone Cements

-     Surgically invasive

-     Long term use

Orthopaedic Implants

-     Surgically invasive

-     Long term use

-     Implantable devices

Internal Prosthetic replacements

-     Surgically invasive

long term use

implantable devices)

·     Certification by a notified body is required with regard to the quality management system (ISO 13485 / IS 15579) raw material used, packaging used, sterilization validation. Certification of design if the design is already in use by others and manufacture of the device.

·     CLAA will register the manufacturer on the basis of Notified body’s assessment, if the design is already in use by others.

·     Manufacturer required to apply for manufacturing license to CLAA with supportive documents with respect to safety and effectiveness of device.

·     The manufacturing license will be issued by CLAA on the basis of above documents and certificate issued by the notified body.

 

S. NO.

RISK CLASSIFICATION

PRODUCT

REQUIREMENTS

4

D

Catheter

-     Short term use

-     Surgically invasive

-     Direct contact with central circulatory system

Cardiac Stents

-     Surgically invasive

-     Long term use

-     Direct contact with central circulatory system

Drug Eluting Stents

-     Surgically invasive

-     Long term use

-     Direct contact with central circulatory system

Heart Valves

-     Surgically invasive

-     Long term use

-     Direct contact with Heart

 

·     Certification by a notified body is required with regard to the quality management (ISO 13485) raw material used, packaging used, sterilization validation & manufacture of the device.

·     Manufacturer required to apply for registration  to CLAA with supportive documents with respect to safety and effectiveness of device.

·     Manufacturer facility may be audited by a team of auditor from notified body (an interim team may be formed by CLAA) to assess the compliance with Quality Management system standards ISO 13485 / IS 15579 (if required representative from state & CLAA can accompany the team as observers).

·     Manufacturing license will be issued by CLAA based on the recommendation of the auditors.

 

B. DOCUMENTS REVIEW

For Class A Product: - No review of documents.

For Class B Product: -

I – Review for the compliance with the Essential Principles of safety and Performance   (EPSP) as per   check list (Annexure 1) and Risk Analysis.

II - In case manufacturer has certified quality management system (as per ISO 13485 / IS 15579): approval can be permitted on the basis of such certificates – No review of documents required.

III – In case manufacturer does not have a certified quality management system following documents will be reviewed: -

1. Product description

2. Product classification

3. Life time of the product (shelf life if applicable)

4. Product specification / reference standard (refer note – 1)

5. Material specification

6. Product component and assembly drawings

7. Instruction of use / Label.

8. Process flow chart (brief description of manufacturing process)

9. Inspection procedure & sample test report.

10. Sterilization process validation (where appropriate)

11. EPSP Checklist

12. Undertaking to achieve ISO 13485 / IS 15579 Compliance within 12 months.

13. Copy of repeat orders from Indian Institutions/Overseas clients to demonstrate product acceptance ( waiver in case of new facility may be considered).

14. Layout of Plant

15. Environmental Controls (if applicable)

 

IV. For Class C Product: -

-          Related technical documents

-          Risk management documents

-          Product design dossier

(Refer note – 2)

V. For Class D Product: -

-          Related technical documents

-          Risk management documents

-          Product design dossier

(Refer note – 2)

 

C. PRE MARKET APPROVAL

I. For Class A Product: - Not required

 

For Class B Product: -

II. - In case manufacturer has certified quality management system (as per IS 15579/ISO 13485) and compliance  with EPSP checklist requirements ; approval can be permitted on the basis of such certificates/compliance.

III.     In case C-II is not possible  B-III may be considered and on the basis of adequacy review may be considered.

For Class C Product: -

IV - After reviewing notified body certification and technical documentation submitted by the manufacturer. Approval can be permitted.

V – In case manufacturer does not have a certified quality management system: Approval can be permitted on the basis of adequacy review of documents submitted by the manufacturer. Refer to annexure – I (Checklist as a guideline document for possible compliance).

 

 

VI - For Class D Product: - After reviewing notified body certification and technical documentation submitted by the manufacturer and the recommendation of the team of auditors, approval can be permitted.

 

Note – 1 – BIS or ISO standard will be applicable for raw material and sterilization process & packaging. For Design the standards should be taken as guideline only depending upon choice of manufacturer. In case BIS or ISO standard not available, company’s own standard can be applied. In case BIS or ISO standard are available but not applicable, justification for accepting company’s standard with cross reference to BIS or ISO standard for specific parameters to demonstrate compliance with Essential Principles of safety and Performance (EPSP) is required.

 

Note – 2

  1. Technical documentation shall be as per Checklist in annexure – II
  2. Product design dossier shall be as per Checklist in annexure – III
  3. Risk management documents shall be as per Checklist in annexure – IV.

 

Note – 3

  1. Application form reference for the registration may be treated as the informal registration number till the manufacturing firm is registered.
  2. Manufacturing License may be issued on priority to the compliant manufacturing units.

Note – 4

Transition Period – Since the requirements of medical devices are significantly different from those for the pharmaceuticals product, adequate transition period will be provided to the manufacturer for compliance and the regulators for acquiring knowledge in regulating medical devices which will be effective from the date of release of these guidelines.

 

 

 

Proposed transition period for the product of different risk classes is as follows:

For Class D products – One year

For Class C product – One and Half year

For Class B and A products – Two years

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on: 09.04.09

 

Copyrights 2009. Association of Indian Medical Device Industry.