DCGI Constitutes MDTAG To Advise CDSCO On Matters Related To Regulation Of Medical Devices

Mumbai, 26 July 2019:

In order to advise Central Drugs Standard Control Organisation (CDSCO) on matters related to regulation of medical devices, the Union health ministry has constituted a Medical Devices Technical Advisory Group (MDTAG) with Drugs Controller General of India (DCGI) as the Chairperson and Deputy Drugs Controller of India, Medical Devices Division, CDSCO as the Member Secretary.

MDTAG has been envisaged to examine the issues relating to implementation of medical devices regulations, suggest CDSCO regarding strengthening of medical devices regulations in the country including Make in India, ease of doing business etc. and taking up matters with Drug Consultative Committee (DCC), Drug Technical Advisory Board (DTAB) and the Union health ministry as per requirement.

The meeting will be called by DCGI at least once in four months at CDSCO, headquarters, New Delhi. The group may co-opt other experts from relevant field as deemed necessary.

MDTAG will have representatives from Department of Science and Technology(DST), National Institute of Biologicals (NIB), Indian Council of Medical Research (ICMR), Atomic Energy Regulatory Board (AERB), Defence Research and Development Organization (DRDO), Bureau of Indian Standards (BIS), IIT, New Delhi, Department of Electronics and Information Technology (DEITY), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), National Health Systems Resource Centre (NHSRC), state drugs controller (Haryana state), Confederation of Indian Industry (CII), Medical Technology Association of India (MTAI), Association of Diagnostics Manufacturers of India (ADMI), Association of Indian Medical Device Industry (AIMED), Federation of Indian Chambers of Commerce and Industry (FICCI) and American Chamber of Commerce in India (AMCHAM India) as its members.

Besides this, it will have members which are representatives from notified body like Dr. Sandeep Bansal, HOD, Cardiology, VMMC and Safdarjung Hospital, New Delhi, Dr SN Bhattacharya, head, Department of Dermatology, University College of Medical Sciences, New Delhi, Dr. Vijay Kumar Jain, associate professor, Department of Orthopaedics, RML Hospital, New Delhi, Dr Arjun Ahuja, head, Seth G S Medical College and KEM Hospital, Mumbai.

As per the notice, all associations and government departments are requested to nominate their representative indicating name, designation, contact number and email id and inform CDSCO at the earliest.

SOURCE : Pharmabiz