The Union Health Ministry is working on the second draft of a legislation to regulate sale of medical devices. The first one was withdrawn after resentment from the industry. The central government has proposed that all unapproved medical devices marketed in the country would have to be licensed within six months of the draft rules.
Out of the thousands of medical devices in the market, only 15 are at present regulated by the Drugs Controller General of India (DCGI). Medical devices licensed under the old rules would have to get fresh licenses within 18 months. Medical devices will be classified based on the severity of the associated risk. Devices with the lowest risk would be classified as Class A; the ones with low moderate risk as Class B; the ones with moderate high risk as Class B and the ones with the highest risk as Class D.
Class A devices will not be regulated. A central medical device testing and evaluation center will be set up. For Class C or Class D devices, an audit by such testing centers will be mandatory. The DCGI will be the central licensing authority to enforce rules relating to import and manufacture of Class C and Class D medical devices. DCGI will also enforce regulations regarding clinical investigation and clinical performance evaluation of medical devices. The respective state drug controller will be the state licensing authority responsible for enforcing rules in matters relating to manufacture of Class A or Class B medical devices.