New Medical Device Regulation Draft in India

After extreme scrutiny in the global market, the India CDSCO has begun to align India’s regulations with international standards. Previously, drugs and medical devices in India were both regulated under the Drugs and Cosmetics Act of 1940. After failing to amend the Act in 2013, the CDSCO decided to draft two legislations instead – one for drugs and one for devices – which are scheduled to be ready by August 2016. The new laws distinguish medical devices from drugs, outline various types of medical devices, make improvements to the clinical trial process, and expand the registration process to many medical devices that were previously not required to be registered.