CDSCO Notifies 6 Bodies To Audit Medical Device Manufacturing Sites

CDSCO Notifies 6 Bodies To Audit Medical Device Manufacturing Sites

Mumbai, 2 Aug 2019:


The medical devices division of Central Drugs Standard Control Organisation (CDSCO) has notified 6 bodies to carry out auditing of manufacturing sites as per the provisions of new MD Rules.


New Medical Device (MD) Rules 2017 were notified last year and has come into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.


MD Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate manufacture, import, sale and distribution of the medical devices.


The notified bodies registered with CDSCO under provisions of medical devices rules, 2017 are Intertek India Pvt. Ltd, TUV Rheinland India Pvt. Ltd, TUV Sud South Asia Pvt. Ltd, Dnv GI Business Assurance India Private Limited, BSI Group India Pvt. Ltd and BSCIC Certifications Pvt Ltd.


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 Maharashtra Food and Drug Adminsitration (FDA) conducted workshops to sensitise drug inspectors about new MD rules.


The state drug regulator has notified 100 medical device officers, seven assistant commissioners and seven joint commissioners as notified licensing authorities to implement MD Rules 2017.


Notified officers have got user id and password for effective implementation of new MD rules through centralised online service SUGAM portal


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. Pharmabiz