Maha: FDA asks medical device manufacturers to register under Medical Devices Rules 2017

Nagpur: The Food and Drug Administration (FDA) has issued a notice following instructions from the Central Drug Standard Control Organization (CDSCO), urging medical device manufacturers to register themselves under the Medical Devices Rules, 2017 and switch to the new licensing regime.

It has been stated that legal action will be taken if not re-registered by September 2022. Previously, notified medical devices were registered under the Drugs and Cosmetics Rules, 1945.

Among the medical devices categorized as low risk (group A), low moderate risk (group B), moderate high risk (group C) and high risk (group D) are those used for preventive care, diagnosis, or therapy. Groups A and B will be controlled by state officials, while Groups C and D will fall under the central government's jurisdiction.

Also read- Zydus Pharma Gets USFDA Nod For Roflumilast Tablets

TOI sources have reported that four manufacturers have already re-registered themselves according to CDSCO guidelines, including three from Wardha and one from Nagpur. Following the new rules, five manufacturers, including four in Nagpur and one in Wardha, have acquired licenses.