Medical devices now get a voluntary certification scheme

A voluntary certification scheme for medical devices was today rolled out in a bid to address lack of quality assurance for products manufactured in the country.
The joint initiative by the Association of Indian Medical Device Industry (AIMED), the Quality Council of India and the National Accreditation Board for Certification Bodies (NABCB) seeks to ensure availability of quality products to end-users.
Pharmaceuticals Secretary V K Subburaj said: "Now, Indian manufacturers can go to the third-party certification agency and certification is voluntary in nature. This will give confidence to manufacturers, consumers and doctors."
He hailed the initiative -- Indian Certification of Medical Devices Scheme (ICMED) -- as "a very significant step" for the development of the medical devices sector.

AIMED Joint Coordinator Rajiv Nath told PTI: "This is a voluntary quality certification. We have launched the scheme today. The implementation will be done during this year."
ICMED brings quality, accountability and competitiveness in the system, he added.

"We do hope that in due course, a regulatory framework will be created in India which will take advantage the system we are creating for third-party certification through competent, qualified auditors," Nath said.
The scheme launched today has two options for certification -- 'ICMED 9000 certification' for low-risk medical devices and 'ICMED 13485 certification' for medium and higher risk devices.
ICMED is the culmination of an MoU signed between QCI and AIMED on October 30, 2014.