The Union ministry of health and family welfare has come out with the guidelines for licensing of import and manufacture of medical devices in India. The guidelines for the devices including Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, I.V. Cannulae, Bone cements, Heart Valves, Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic replacements are effective from March 1, 2006.
Accordingly, for the import of these devices considered as drugs under section 3 (b) (4) of Drugs and Cosmetics Act, the procedures for registration and import license as prescribed under the D&C rules will have to be followed. A period of 60 days would be provided for the importers to file an application for import and registration from the date of issue of these guidelines. The devices, which have not been imported in the country before notification, will not be permitted without the approval of the competent authority.
The sale of devices, which are currently in use, will be permitted for the period of about six months until the application for import is approved or rejected. In case of stents and drug eluting stents (DES), 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 guidelines. Separate committee that would formulate its own benchmarks and procedures for evaluation and standards of devices would be setup for evaluation of specific categories of devices.
The guidelines also include the procedures for registration of medical devices. For the registration, one has to submit applicant details, product information, regulatory status of the product including approval from any other regulatory agency like US FDA, EU medical device directive (CE certificate), approval from Australia, Canada, Japan or any other country, ISO/EN certification, countries where the device is being sold or withdrawn from sale, master file with details of GMP employed by the manufacturer to ensure quality of the device, devices containing medicinal product, post market surveillance and undertaking of conformity with respect to product standards, safety and effectiveness requirements and quality systems in the country of origin.
For applying for the manufacturing license of medical devices in the country, manufacturer has to submit manufacturing and product details. The state licensing authority after joint inspection and verification would forward the license to CLAA for approval. The control over the manufacture of these devices would be exercised by DCGI under the Drugs and Cosmetics Act.
For the sale of devices in the country, the importers, stockists and retail sellers have to obtain sale licenses from the state licensing authority within a period of three months from the issue of these guidelines.