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CDSCO reaches consensus to roll out medical devices regulations in phased manner

Laxmi Yadav, Mumbai
Saturday, February 9, 2019, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organization (CDSCO), the national medical device regulator, on Friday held first meeting to discuss the road map for regulating the sale and use of medical devices.

At the meet, a consensus was reached to roll out medical devices regulations in a phased manner and constitution of medical devices - expert advisory group (MD-EAG) to aid health ministry in this regard.

The participants such as representatives from medical device industry, director (drugs), Union ministry of health and family welfare ministry, Drugs Controller General of India agreed on series of initiatives to regulate medical devices in the country.

These include separate and clear law for regulation of all medical devices in the country; separate medical devices authority (or revamping of CDSCO) in due course; no compromise on quality & safety of medical devices, implementation of defined transition time & competency building measures including infrastructure, training for regulators and industry and representation on Drugs Technical Advisory Board (DTAB) by a medical device industry nominee as a special invitee until Medical Device Technical Advisory Board (MTAB) gets constituted.

The consensus was also built into registration of all manufacturers and importers of all non notified medical devices at earliest; devices' labels to carry registration number and address to enable traceability; mandatory listing of importers & manufacturers' ISO13485 certification from National Accreditation Board for Certification Bodies (NABCB)/International Accreditation Forum (IAF) and defining traceability criteria for verification of manufacturing site & commercial office.

This will create a new regulatory marketing approval system and the government will come to know who imports, who manufactures what. As of now its all unknown in absence of data and facts. Hence, it is impossible to take correct policy decisions, said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) who was present at the meet.

Besides this, participants also agreed to strengthen serious adverse event reporting mechanism.

“We complement CDSCO and health ministry in listening to our requests to bring in a separate regulatory framework for medical devices independent of drugs and carry forward the initial rolling out of regulations from the launch of Medical Devices Rules earlier in January 2018 to a logical conclusion. A restart of the process that had stalled has been made. We hope the health ministry will act on these suggestions and stop procrastinating in order to ensure patient safety and encourage domestic manufacturing that had been negatively impacted in absence of a predictable regulatory environment,” said Rajiv Nath.


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Morulaa Mar 20, 2019 2:10 PM
Great article. We need to constantly be aware of the changing regulatory scenario : https://morulaa.com/registration-services-in-india-cdsco/?
Shafi Feb 9, 2019 7:16 PM
This is a very good suggestion according to me,
I am a student from Bangalore
Actually we have to be more stringent with respect to the manufacturers , it is a matter of patients health.
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