Exactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.
Notice number DCG(I)/Misc./2017(68) reiterates the 15 medical device categories that currently require registration under the current Drugs & Cosmetics Act, 1940. The document appendix further delineates 462 medical devices and 250 IVD devices and accords a risk-based classification as per the new Medical Device Rules 2017. It is likely that these products will be subject to the new Rules on January 1, 2018. Other medical devices are expected to be added to this list in phases starting with high risk devices and devices of special or national interest to India.
In the meantime, the DCGI requests manufacturers, importers and distributors of medical and IVD devices to adhere to the new Medical Device Rules on a voluntary basis in anticipation of their comprehensive application.
A copy of this Notice and the Rules are available on the India page of Asia Actual’s website.