A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 17th Year of Publication
Page 4 of 4

Cover Story

Guidance Document On Application For Grant Of Licence
For Manufacture of Medical Devices in India : Abstracts

The Highlights of Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme By Central Drugs Standard Control Organisation (Medical Devices Division) is reproduced below. More details are available on CDSCO website.

A. Preface

The proposed Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme is uploaded for the  information of all stakeholders.

Any person interested making any suggestions on the proposed draft guidance documents may do so in writing for consideration of the CDSCO with in a period of 20 days from the date of its uploading through post to the Drugs Controller General (India), CDSCO, FDA Bhavan, Kotla Road, New Delhi - 110002 and through email at cdamdi@gmail.com.

The document is intended to provide non-binding guidance for use in the regulation of medical devices.

B. Requirements for Grant of Licence in form-28 for Manufacture of
     Medical Devices India

Application for the grant of licence for manufacture of Medical Devices in India shall be made in Form 27 to :-

  1. The concerned State Drugs Licensing Authority, ( )

  2. The concerned CDSCO Zonal/Sub-Zonal Office ( ) and

  3. The Drugs Controller General of India CDSCO (HQ), FDA wan, Near Bal Bhawan, ITO, Kotla Road, New Delhi-110002.

Accompanied by the requisite fee in the form and manner as prescribed in the Drugs & Cosmetics Rules.

The following documents are required to be submitted in the following manner and order for grant of licence in form-28 for Manufacture of Medical Devices in India: -

  1. Covering Letter

  2. An Authorization letter

  3. A duly filled Form 27

  4. The requisite fee

  5. Constitution Details

  6. Approved Manufacturing Premises Plan/Layout

  7. Full particulars of competent and regular technical staff

  8. Site Master File

  9. Specific Requirements

  10. Device Master File

  11. List of Medical Devices along with undertaking in prescribed pro-forma.

  12. ISO 13485:2003 Certificate (if any)

  13. Full Quality Assurance Certificate

  14. CE Design Certificate

  15. Declaration of Conformity (if any)

  16. Any Other Approvals (e.g. US FDA)

ANNEXURE-III

FORM 27

Application for grant or renewal of a [licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) [excluding those specified in Schedule XB and Schedule X]

ANNEXURE - IV

Site Master File

NOTE : The manufacturer shall submit the duly signed information pertaining to Manufacturing premises in the following format.

No. Requirements
A GENERAL INFORMATION
I Brief information on the site (including name and address), relation to other sites
II Manufacturing activities as licensed by the Competent Authorities
III Any other operations carried out on the site
IV Name and exact address of the site, including telephone, fax numbers, web site URL and e-mail address
V Type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken
VI Short description of the site (size, location and immediate environment and other activities on the site)
VII Number of employees engaged in Production, Quality Control, warehousing, and distribution
VIII Use of outside scientific, analytical or other technical assistance in relation to the design, manufacture and testing.
IX Short description of the quality management system of the company
X Devices details registered with foreign countries
B PERSONNEL
I Organisation chart showing the arrangements for key personnel
II Qualifications, experience and responsibilities of key personnel
III Outline of arrangements for basic and in-service training and how records are maintained
IV Health requirements for personnel engaged in production
V Personnel hygiene requirements, including clothing
C PREMISES AND FACILITIES
I Layout of premises with indication of scale
II Nature of construction, finishes/fixtures and fittings
III Brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (including schematic drawings of the systems). Classification of the rooms used for the manufacture of sterile products should be mentioned
IV Special areas for the handling of highly toxic, hazardous and sensitizing materials
V Brief description of water systems (schematic drawings of the systems are desirable) including sanitation
VI Maintenance (description of planned preventive maintenance programmes for premises and recording system)
D EQUIPMENT
I Brief description of major production and quality control laboratories equipment (a list of the equipment is required)
II Maintenance (description of planned preventive maintenance programmes and recording system).
III Qualification and calibration, including the recording system. Arrangements for computerized systems validation.
E SANITATION
I

Availability of written specifications and procedures for cleaning the manufacturing areas and equipments

F PRODUCTION
I Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters
II Arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage.
III Arrangements for reprocessing or rework
IV Arrangements for the handling of rejected materials and products
V Brief description of general policy for process validation
G QUALITY CONTROLS
I

Description of the Quality Control system and of the activities of the Quality Control Department. Procedures for the release of finished products

H STORAGE
I Policy on the storage of medical device
E DOCUMENTATION
I

Arrangements for the preparation, revision and distribution of necessary documentation, including storage of master documents

F MEDICAL DEVICE COMPLAINTS AND FIELD SAFETY CORRECTIVE ACTION
I Arrangements for the handling of complaints
II Arrangements for the handling of field safety corrective action
G SELF INSPECTION
I Short Description of the internal audit system
H CONTRACT ACTIVITIES
I

Description of the way in which the compliance of the contract acceptor is assessed

ANNEXURE - V

SPECIFIC REQUIREMENTS

1. Moulding, Assembly and Packing area; (HVAC)

  1. The Plastic or Rubber based components May be moulded/extruded in positive pressurized, ventilated area complying to a Clean Zone as per ISO 14644-1 of at least Class 9 and subsequently assembled/processed and packed in Clean Room as per ISO 14644-1 of at least Class 7 (at rest condition).

  2. Component of Orthopaedic Implants may be initially Prepared and Processed (cutting, lathing, etc.) in a well ventilated area. Polishing, cleaning and packing of Orthopaedic Implants (Non Sterile) may be done in Clean Zone as per ISO 14644-1 of at least Class 8. While polishing, cleaning and packing of Sterile Orthopaedic Implants may be done in Clean Zone as per ISO 14644-1 of at least class 7 (at rest condition) and final packing should be carried out under Laminar Air Flow work station.

  3. For high risk devices like cardiac stents, bone cements IOL, etc. coating (if any) and packing should be done under class 5 with a background of class 7.

2. Testing Facilities :

  1. The licensee shall provide testing facilities for requisite tests carrying out Chemical and Physico-Chemical testing of medical devices and of raw materials used in its own premises: Provided that the Licensing Authority may permit the licensee to carry out Microbiological/stability testing [wherever applicable] from an external approved public testing laboratory, at the initial stage.

ANNEXURE-VI

Device Master File

Note: The manufacturer shall submit the duly signed information pertaining to Medical Device in the following format. It is expected that the information submitted in the form of hard copy shall also be submitted in the form of soft copy.

The dossier shall have an index listing the details of the documents produced as requested hereunder and shall reflect the page numbers.

  1. EXECUTIVE SUMMARY (Not more than three A4 size pages)

  2. DEVICE DESCRIPTION AND PRODUCT SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

  3. LABELLING

  4. Device Description and Product Specification, Including Variants and Accessories

  5. ESSENTIAL PRINCIPLES (EP) CHECKLIST

  6. RISK ANALYSIS AND CONTROL SUMMARY

  7. PRODUCT VERIFICATION AND VALIDATION

Back | Back to Top | Previous