India has come up with Medical Devices Rules, 2017

CDSCO has published the Medical Devices Rules 2017.

This Rule has been published in the Gazette of India Extraordinary on 31 Jan 2017.
The Rules are very explicitly explains the requirements from various stake holders and balanced in managing the expectations of stake holders and also the Regulatory agency.

Please find below the link to the Medical Device Rules, 2017.

Medical Device Rule gsr78E

http://cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E.pdf