New Delhi, Aug. 24 -- India's Union Ministry of Health and Family Welfare has officially rolled out targeted amendments to the Medical Devices Rules, 2017, designed to boost Ease of Doing Business (EoDB), eliminate regulatory bottlenecks, and accelerate consumer access to advanced healthcare tech.

The reforms introduce two major structural shifts for manufacturers and importers- loan licensing axed for outsourced sterilisation (Rule 44), and EU added to the clinical trial waiver list (Rule 63).

Manufacturers using third-party sterilisation facilities (provided those facilities hold a valid license under the 2017 Rules) no longer need to apply for a separate loan license.

Eliminating this step slashes administrative duplication, complia...