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.
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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.
There are nine registered manufacturers, six of which produce dressing material that are considered low risk whereas two produce syringes, and one produces laboratory reagents which are considered moderately low risk.
"The notification has gone to all pharmaceutical companies and device manufacturers. Anyone found operating without being registered under the Medical Devices Rules, 2017, post-September, would face action," said an FDA official.
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Medical Devices Rules, 2017
•Medical Device rules are effective from 01.01.2018, under the Drugs and Cosmetics Act 1940 -
• To regulate the Clinical Investigation, Manufacture, Import, Sale and Distribution of the medical devices in the country.
•The Medical Devices Rules, 2017 are harmonized with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices, which will foster Make in India also.
