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

The Union Ministry of Health and Family Welfare has proposed and implemented key amendments to the Medical Devices Rules, 2017, aimed at enhancing the ease of doing business, streamlining regulations, and accelerating access to advanced medical technologies. Key changes include removing the separate loan licensing requirement for manufacturers outsourcing product sterilization to licensed facilities (accompanied by a six-month transition period for labelling), and amending Rule 63 to include the European Union in the list of recognized stringent regulatory jurisdictions for waiving clinical investigation requirements for devices without predicate devices.