TUV Rheinland India announced that it has been approved as a Notified Body by the Central Drugs Standard Control Organisation (CDSCO), India. TUV 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 TUV 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.
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