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Guidelines for Import and Manufacture of Medical Devices

The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the Act.

  1. Cardiac Stents.

  2. Drug Eluting Stents.

  3. Catheters.

  4. Intra Ocular Lenses.

  5. I.V. Cannulae.

  6. Bone Cements.

  7. Heart Valves.

  8. Scalp Vein Set.

  9. Orthopedic Implants.

  10. Internal Prosthetic replacements.

It was also notified vide GSR 627 (E) dated 7/10/2005 that control over manufacture of these devices would be exercised by CLAA i.e. DCG(I) under the said Rules.

The Ministry of Health and Family Welfare have now approved the following procedures to be adopted in respect of licensing of import as well as manufacture of these Medical Devices in the country.

These guidelines shall be effective from 1st March 2006

IMPORT OF MEDICAL DEVICES

For the purpose of import of Devices specified above, the procedure for registration and import licence as prescribed under the Drugs and Cosmetics Rules shall be followed.

  1. A period of 60 days would be provided for the importers to make application for import and registration from the date of publication of these guidelines.

  2. In case of devices which have not been imported in the country before the date of notification no import would be permitted without the approval of the competent authority. 

  3. For the time being and for a period upto six months, until an application is approved or rejected, whichever is earlier, the devices which are currently in use will be permitted to be sold. In case of stents or drug eluting stents the import will not be permitted if the applicant has not sold less than One thousand stents of the particular specification prior to the date of issue of these guidelines. 

  4. Separate committees consisting of subject experts and representative of DCG(I) office would be setup for their expert advice for evaluation of specific categories of devices. The expert committees would formulate their own benchmarks and procedures for evaluations and the standards to which such devices should conform.

Detailed guidelines regarding following requirements are given at www.cdsco.nic.in

  1. Registration of Medical Devices for Import

  2. Applicant Details

  3. Product Information

  4. Regulatory Status

  5. Master File (Details of Good Manufacturing Practices employed by the manufacturer to ensure quality of the device)

  6. Devices containing medicinal product

  7. Post Market Surveillance

  8. Undertaking of conformity with respect to product standards, safety and effectiveness requirements and quality systems in the country of origin.

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