The new set of Medical Devices Rules 2017, separating medical device industry from the pharmaceutical sector, has taken effect from January 2018 - Thomas Fuhrmann, MD, TUV Rheinland India

"TUV Rheinland India, in its capacity as a Notified Body by CDSCO, India will undertake on-site audit of the Quality Management Systems of the Medical Device Manufacturers of Class A and Class B categories, and may, on a case to case basis, be called upon to help in the verification and assessment of Class C and Class D medical devices" added Thomas Fuhrmann.

"The new rules are aimed to standardise and regulate medical devices manufacturing industry, on par with international standards and have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and follow best international practices" said Kalyan Varma, Vice President, Business Stream Products-IMEA, TUV Rheinland. "Medical devices are life-saving products and have to be produced with quality materials and as per good manufacturing practices. We are extremely pleased to be a part of this initiative by the Government that will boost its ‘Make in India' campaign by providing conducive environment for domestic Medical Devices manufacturers that could lead to greater long-term investments"

TUV Rheinland has been in India since 1996. Today, its nationwide presence includes over 100 locations providing testing, training, inspection, and certification services to the industry through its Industrial Services, Mobility, Products, Softlines, Academy & Life Care, Systems and Information communication Technology divisions. Offering more than2,500 services, TUV Rheinland India caters to almost every industry.

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