Medical device manufacturing sites will be audited by 6 bodies: CDSCO

According to the new MD Rules, the 6 bodies are notified by the CDSCO to audit the medical device manufacturing sites.

The new MD Rules 2017 became effective since 01 January 2018. These rules are meant for the regulation of manufacturing, import, sale and distribution of medical devices as per Drugs and Cosmetics Act.

TUV Rheinland India Pvt. Ltd, Intertek India Pvt. Ltd, BSI Group India Pvt. Ltd, Dnv GI Business Assurance India Private Limited, BSCIC Certifications Pvt Ltd and TUV Sud South Asia Pvt. Ltd are the notified bodies registered with the CDSCO.

Invitro diagnostics, ligature, bandages, medical devices, surgical sutures and disinfectants are covered under new MD rules 2017. It introduces new standards for development and utilization of medical devices.

For audits and inspections of Class A and Class B medical device categories, state licensing authority must send applications to notified bodies. However, the CDSCO will independently audit the Class C and Class D categories of medical devices.

The Maharashtra Food and Drug Administration (FDA) organized workshops to instruct drug inspections about the effective implementation of new MD Rules. SUGAM, a single window online service is launched by the CDSCO to grant import, manufacturing, sale, license distribution and clinical investigation of medical devices.