.MANUFACTURE OF MEDICAL DEVICES IN THE COUNTRY

1. Application for the grant of licence for manufacture of these notified sterile Devices in the country shall be made in Form 27 to the State Licensing Authority, accompanied by the requisite fee in the Form and manner as prescribed in the said Rules along with a copy to the office of DCG(I).

2. A period of 60 days would be provided for making the application for manufacture from the date of publication of these guidelines.

3. In case of devices belonging to above said categories which have not been manufactured in the country before the date of notification, no manufacture would be permitted hence forth without the approval of the competent authority as per norms prescribed.

4. The applicant shall provide the following information along with the application for consideration of the licensing authority.

Manufacturing Details:-

1. Complete details about the names, addresses of the directors of the company and addresses of the manufacturing premises and registered offices of the manufacturer.

2. A brief project highlight indicating the plans of the company, devices to be manufacture, their viability and other relevant profiles.

3. Copy of the Site Master File.

4. A brief description of the manufacturing process of the devices to be manufactured.

5. Details of the standards followed by the company for Good Manufacturing Practices and product evaluation.

6. Name, qualification and experience of technical staff under whose supervision the devices will be manufactured.

7. Copies of ISO or any other certifications, if any, obtained by the firm for its manufacturing facility.

Product Details:-

1. Proprietary/Brand name.

2. Brief description of the device.

3. Category of device.

4. Intended use and method of use.

5. Medical specialty in which the device is used.

6. Qualitative and quantitative particulars of the constituents.

7. Specifications of the materials used.

8. Testing facilities available in the manufacturing premises for testing.

9. Standards and procedures for testing the device.

10. Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.

11. List of accessories and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.

12. Information on stability of the product.

13. Details of clinical trials, (wherever applicable) carried out on the product.

14. Variations in shape, style or size of the device, if applicable.

15. Labeling details conforming to Drugs and Cosmetics Rules, 1945.

16. Physician manual and promotional literature (Literature insert) in English. (if any)

17. Packaging description including pack sizes.

18. Recommended storage conditions.

19. Summary indications of any reported problems.

5. For the purpose of evaluation of Medical Devices which are new or do not have any benchmark certification, Expert Committees shall be setup to examine in detail the information provided by the applicant for the assessment of the device.

6. The committee after completing their assessment forward the opinion regarding suitability of the device to the competent authority for the purpose of grant of permission for placing the device in the market.

7. The State Licensing Authority after Joint Inspection and verification would forward the licence to CLAA for approval.

8. The licence shall be issued in Form 28 of the said Rules after due approval of CLAA. 

SALE OF MEDICAL DEVICES IN THE COUNTRY

The importers, stokists and retail sellers of Medical Devices shall obtain appropriate sale licences from the State Licensing Authorities for these Medical Devices within a period of 3 months form the issue of these guidelines.

( http://www.cdsco.nic.in/medical%20device%20A4.htm )