India Proposes Quality Certification for Medical Devices

On December 15, 2008, India’s Minister of Science and Technology, Kapil Sibal, discussed coming medical device regulations at a conference in New Delhi. These regulations are to be submitted to India’s cabinet soon by the Department of Science and Technology, which oversees the medical device industry (though it does not register medical devices).

The outlined measures would require ISO certification of medical devices and their manufacturers before they could be sold in India. Currently, only ten specified types of high-risk medical devices (and a few smaller items) need registration in India before marketing. These new standards, likely to be ISO 13485, would apply to medical devices of all or most types. The Bureau of Indian Standards currently manages ISO certification in India through notified bodies, but overseas certifications may also be accepted.

The conference, “Optimizing Healthcare Delivery in India,” was on increasing the affordability of medical treatment to Indians, and the measures described by Mr. Sibal focused on this goal. He described the measures as designed to promote domestic Indian production of medical devices, creating more competition to imported devices and thereby lowering prices.

Other measures Mr. Sibal highlighted at the conference included increasing R&D in medical technology, genomics, and vaccines, as well as improving the supply and quality of Indian healthcare professionals, who are currently in high demand.