The Gujarat Food and Drug Control Administration (FDCA) has notified 90 medical device officers to implement the new Medical Device (MD) rules in the state.
The state regulator had earlier sent draft notifications to the state government to designate notified officers to regulate 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.
Depending on the risk involved, Central Licensing Authority has classified the medical devices into four classes i.e Class A, Class B, Class C and Class D.
The state regulator is also planning to conduct workshops to sensitise inspectors on newly notified medical device rules 2017.
Says Dr H G Koshia, Gujarat FDCA Commissioner, “We are in the process of forwarding applications of manufacturers under category B medical devices to seek inspection reports from the notified bodies recently appointed by the 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.
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.