On July 12, the Ministry of Health and Family Welfare published a draft of new medical device regulations (Medical Device Rules, 2016) which will require registration for all medium to high risk medical and IVD devices. Implementation could happen as early as year end.
Under the current regulations, only 23 types of medical and IVD devices require registration, and so, this proposal represents a significant change to the regulatory requirements for most medical device manufacturers selling or intending to sell in India.
The current draft of the Rules calls for exemption of Class A devices and a 180-day grace period for filing registration applications for Class B, C, and D devices. Existing Product Registration certificates will remain valid through their expiry date.
This action follows last month’s withdrawal of draft medical device regulations by the National Assembly after 2 years of deliberation. This new proposal is at the ministerial level and more likely to be implemented quickly. More details and guidance are expected in the coming weeks.