The Maharashtra Food and Drug Administration (FDA) has notified 100 medical device officers, seven assistant commissioners and seven joint commissioners as notified licensing authorities to implement Medical Device (MD) Rules 2017. This comes close on the heels of appointment of notified bodies at Central Drugs Standard Control Organisation (CDSCO).
Intertek India Pvt Ltd and TUV Rheinland India Pvt Ltd have been notified and registered with the CDSCO to carry out auditing of manufacturing sites as per the provisions of new MD Rules.
MD Rules 2017 were notified last year and has come into effect from January 1, 2018. As per the new rules, manufacturers are expected to adhere to stringent quality management system (QMS) while carrying out manufacturing of medical devices.
New MD Rules 2017 cover medical devices, invitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices.
State licensing authority has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new rules. Class C and Class D category are audited by the CDSCO independently as per the new rules. In order to implement MD rules effectively, the state regulator conducted workshops to sensitise drug inspectors.
Explains Amrut Nikhade, joint commissioner, Maharashtra FDA, “The notified officers have got user id and password for effective implementation of new MD rules through centralised online service SUGAM portal and it is now a win-win situation for both the medical device officers and manufacturers.”
CDSCO had launched the online service SUGAM for grant of import, manufacture, clinical investigation, sale and distribution licences of medical devices through single window clearance.
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. Issues related to post grant compliance, data protection, product recalls and product liabilities among others have also been raised by industry and legal experts towards effective compliance.