Medical Devices Get Voluntary Certification Scheme

New Delhi : A voluntary certification scheme for medical devices was on Tuesday 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.

"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," Pharmaceuticals Secretary V K Subburaj said.

He hailed the 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. 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," Mr Nath said.

The scheme launched on Tuesday has two options for certification - 'ICMED 9000 certification' for low-risk medical devices and 'ICMED 13485 certification' for medium and higher risk devices.