I did research about the regulations in India, and I found that, India is one of the largest medical device markets in Asia, and is still growing at an impressive rate. Prior to 2005, no medical device regulations existed in India! -(System C as DR.Simon mentioned),
The registration process for medical devices in India remains fluid, but regulators are taking steps to develop a more formalized oversight policy. Also, no specific medical device classification currently exists in India.
For clinical trials: if your product has already obtained US-FDA clearance or approval, for example, you will not need to conduct further clinical trials in India!
However, today there are new registration procedures for certain types and classes of medical devices regulated under the provisions of the Drugs and Cosmetics Rules. The new regulations will take effect on January 1, 2018 in India:
” Manufacturers interested in registering their medical devices in India must supply evidence of prior regulatory authorization in the US, Canada, Europe, Australia or Japan, as well as proof of approval in their home market. Additionally, each manufacturing facility must be registered.”