Notify Body TUV Rheinland, which caters to almost every industry, offering testing, training, inspection, and certification services are now in India. The Central Drugs Standard Control Organisation(CDSCO), has already approved TUV as a Notify Body in India.

An online digital platform- SUGAM has been created to make 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, labeling, manufacture…

There will be 4 classifications of Medical Devices, A, B, C and D. Low-risk Medical Devices are classified as classes A and B, and classes C and D are high-risk devices, which require the Central Government's attention.

From now, TUV will be able to attend on-site audits of Quality Management Systems of Medical Devices classified as class A and B. and may help class C and D devices with the verification and assessment process.