The Government has undertaken key regulatory reforms in the medical device sector to promote Ease of Doing Business.

 

Health and Family Welfare Ministry, in a statement, said that the reforms include amendments to the Medical Devices Rules, 2017 in three key areas. Simplification of provisions relating to outsourced sterilisation of medical devices, introduction of uniform testing fees and inclusion of the European Union among recognised jurisdictions for waiver of clinical investigation requirements.

 

The Ministry highlighted that the reforms are expected to simplify regulatory processes, reduce compliance costs, enhance transparency and predictability, and facilitate the timely availability of advanced and innovative medical devices in the country. It will also mark an important step towards strengthening the medical device regulatory ecosystem and promoting greater international regulatory convergence.