The Maharashtra Food and Drug Administration (FDA) is awaiting notifications from the Central Drugs Standard Control Organization (CDSCO) on the categorisation of medical devices for implementation of New Medical Devices (MD) Rules 2017.
New MD Rules 2017 effective from January 1, 2018 cover not only medical devices but also in vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, etc. It sets new standards for manufacturing and use of medical devices. The Central Licensing Authority will notify medical devices based on four classes i.e Class A, Class B, Class C and Class D depending on the risk involved.
Explains Maharashtra FDA Commissioner Dr. Pallavi Darade, “Once the devices are categorised and notified, we will start implementing the new medical devices rules with the help of medical device officers designated by the central and state governments for the purpose.”
Maharashtra FDA has already urged the CDSCO to notify bodies, officers and labs designated for the purpose of overseeing the compliance of new Medical Device Rules, 2017.
The state regulator has also concluded workshops to sensitise drug inspectors on newly notified medical device rules 2017. Around 200 drug control officers from Maharashtra, Madhya Pradesh, Chhattisgarh, Goa, Daman and Silvassa participated in a workshop in Mumbai.
Medical devices such as cardiac stents, catheters, intraocular lenses, etc have been notified pursuant to the action taken by Maharashtra FDA in 2005.
Medical Devices Rules 2017 were notified last year and is into effect since January 1, 2018. Industry and legal experts however have been raising some of the contentious issues related to compliance to guidelines which have not been finalised as yet and timelines for its effective compliance.
One such issue is related to the guidelines on essential principles of safety and performance as stipulated in Rule 6 of MD Rules, 2017, which has not been notified as yet and hence the concern is that the companies might not have the time to comply with it as the rules has already come into effect. The subjects included post grant compliance, data protection, product recalls and product liabilities among others.
As per the new rules, manufacturers are expected to adhere to stringent quality management system, while carrying out manufacturing of medical devices.