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 amendments to the Medical Devices Rules, 2017 to promote the ease of doing business, simplify regulatory requirements, standardize testing fees, and facilitate faster market access for medical devices. The amendments focus on three key areas: simplifying provisions for outsourced sterilization by removing the requirement for a separate loan licence under Rule 25 if the facility holds a valid licence; introducing a Ninth Schedule to prescribe uniform testing fees across Medical Device Testing Laboratories; and amending Rule 63 to include the European Union among recognized stringent regulatory jurisdictions for waiving clinical investigation requirements for certain medical devices.