India, Aug. 24 -- image credit- freepik

The government has introduced major regulatory reforms in the medical devices sector with an aim to promote ease of doing business (EoDB), simplify regulatory processes, enhance transparency, and facilitate timely access to advanced medical technologies in the country.

Towards this objective, the Medical Devices Regulations, 2017 have recently been amended to simplify the regulatory framework governing outsourced sterilisation of medical devices and to expand the list of stringent regulatory jurisdictions recognised to remove diagnostic requirements.

The amendment to Rule 44 of the Medical Devices Regulations, 2017 has been finalised after extensive stakeholder consultations aimed at simplifying ...