Six bodies registered with CDSCO to audit medical device manufacturing sites as per new MD Rules
New Delhi: Through a recent public notice, the apex drug regulatory body, Central Drugs Standard Control Organisation(CDSCO) has notified six bodies to carry out an audit of manufacturing site under the provisions of the Medical Devices Rules, 2017.
In this connection, six bodies have been registered with CDSCO. These audit services providers include New Delhi-based Intertek India Pvt. Ltd which was established in the year 1997; TUV Rheinland India Pvt. Ltd located in West Wing, Electronic City in Bengaluru; TUV Sud South Asia Pvt. Ltd situated in Mumbai; Dnv GI Business Assurance India Private Limited, Mumbai; BSI Group India Pvt. Ltd, New Delhi and BSCIC Certifications Pvt Ltd situated in Faridabad.
"The notified bodies registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out an audit of manufacturing site under the provisions of said rules," reads the notice undersigned by the Joint Drugs Controller of India, Dr V G Somani.
New Medical Device (MD) Rules 2017 were notified last year and has come into effect from the beginning of 2018 onwards in the country. MD Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate the manufacture, import, sale and distribution of the 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.
Medical Dialogues had earlier reported that to advice CDSCO on matters related to the regulation and implementation of medical devices, the Union Health Ministry had constituted a special committee under the name Medical Devices Technical Advisory Group (MDTAG), chaired by Drugs Controller General of India (DCGI) while the Deputy Drugs Controller of India, Medical Devices Division, CDSCO had been appointed as the Member Secretary.