In order to implement New Medical Devices (MD) Rules 2017 in an effective manner, the Gujarat Food and Drug Control Administration (FDCA) has sent draft notifications to the state government for approval to designate notified bodies and officers for oversight of medical devices units under the current regulatory framework.

Gujarat has the maximum number of 250 licensed medical devices units which include both low risk and high risk devices.  

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. As per the new rules, manufacturers are expected to adhere to stringent quality management system, while carrying out manufacturing of medical devices.

The state regulator is also planning to conduct workshops to sensitise drug inspectors on newly notified medical device rules 2017.

Meanwhile, Maharashtra Food and Drug Administration (FDA) is also 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.  

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.

Once notified, compliance to the new medical devices rules will be implemented with the help of medical device officers designated by the central and state governments for the purpose.

Maharashtra FDA had earlier urged the CDSCO to notify bodies, officers and labs designated for the purpose of overseeing the compliance of new MD Rules, 2017.
 
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.