TÜV Rheinland India, a subsidiary of the TÜV Rheinland Group, Germany, a worldwide leader, that inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies, announced that It has been approved as a Notified Body by the Central Drugs Standard Control Organisation (CDSCO), India. TÜV Rheinland India will now be able to carry out audit of manufacturing sites of Medical Devices manufacturers as per Medical Devices Rules, 2017.
“The new set of Medical Devices Rules 2017, separating medical device industry from the pharmaceutical sector, has taken effect from January 2018. The Medical Devices Rules will regulate all aspects and activities pertaining to medical devices such as manufacture, sale & distribution, imports & exports, labelling, conducting of clinical trials, registration of laboratories for carrying out tests and recall of devices.” said Thomas Fuhrmann, Managing Director of TÜV Rheinland India “The new rules have eased norms for obtaining license and conducting clinical trials, and also reduced manufacturer-regulator interface by promoting an online digital platform- SUGAM”.
Medical Devices have been classified into four categories based on their risk type - Class A, B, C and D. Class A and B are low risk devices whereas C and D classified as higher risk products. For approvals and licensing in devices falling under categories C & D, Central Government will be directly involved.
“TÜV 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, TÜV 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”