Union Ministry of Health and Family Welfare Proposes Amendments to Medical Devices Rules, 2017 to Promote Ease of Doing Business

India, Aug. 24 -- The Government of India has issued a release:

The Government has introduced key regulatory reforms in the medical device sector with a view to promoting Ease of Doing Business (EoDB), simplifying regulatory processes, enhancing transparency and facilitating timely access to advanced medical technologies in the country.

Towards this objective, the Medical Devices Rules, 2017 have recently been amended to simplify the regulatory framework governing outsourced sterilization of medical devices and to expand the list of recognized stringent regulatory jurisdictions for waiver of clinical investigation requirements.

The amendment to Rule 44 of the Medical Devices Rules, 2017 has been finalized after extensive stakeholder cons...