Notify Body TUV Rheinland, who caters almost every industry, offering testing, training, inspection, and certification services, is now in India. The Central Drugs Standard Control Organisation(CDSCO), have already approved TUV as a Notify Body in India.
An online digital platform- SUGAM has been created to make the registration way easier for manufacturers of Medical Devices, as the new rules regulate each one of the factors and activities of Medical Devices, such as clinical trials, labelling, manufacture…
There will be 4 classifications of Medical Devices, A, B, C and D. Low risk Medical Devices are classified as class A and B, and class C and D are high risk devices, which required the Central Government attention.
From now, TUV will be able to attend on-site audit of Quality Management Systems of Medical Devices classified as class A and B. and may help class C and D devices on the verification and assessment process.
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