Having concluded workshops to sensitise drug inspectors from Maharashtra, Madhya Pradesh, Chhattisgarh, Goa, Daman and Silvassa on newly notified Medical Device (MD) Rules 2017, the Maharashtra Food and Drug Administration (FDA) is all set to implement MD Rules with the appointment of notified bodies at Central Drugs Standard Control Organisation (CDSCO).

Intertek India Pvt Ltd and TUV Rheinland India Pvt Ltd are the notified bodies registered with the CDSCO to carry out auditing of manufacturing sites as per the provisions of new MD Rules.

Meanwhile, the Maharashtra FDA is also awaiting notification from the state government for notifying officers and associated modalities towards implementation of New Medical Devices (MD) Rules 2017.

State licensing authority has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices for compliance. Class C and Class D category are audited by the CDSCO as per rules.

Explains Amrut Nikhade, joint commissioner, drugs, Maharashtra FDA, “We have started sending applications to notified bodies for Class A and Class B manufacturing devices to implement new MD rules.”

Maharashtra FDA had earlier urged the CDSCO to notify bodies, officers and labs designated for the purpose of overseeing the compliance of new Medical Device Rules, 2017.
 
Medical Devices Rules 2017 were notified last year and has come into effect from January 1, 2018. Industry and legal experts however have been raising issues related to post grant compliance, data protection, product recalls and product liabilities among others towards 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. As per the new rules, manufacturers are expected to adhere to stringent quality management system, while carrying out manufacturing of medical devices.
 
New MD Rules 2017 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.