India proposes easing medical device sterilisation rules, adds EU to regulatory list

The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, aimed at easing regulatory requirements for medical device manufacturers and speeding up market access in India. The changes are designed to simplify compliance, standardise testing fees, and facilitate faster entry for eligible devices, according to a ministry release issued on Monday (August 24, 2026).

One proposed change would remove the need for a separate manufacturing licence when companies outsource sterilisation of their medical devices to an already licensed facility. Another would expand the list of countries and regulatory jurisdictions whose approvals can help waive clinical investigation requirements in India, with the European Union added to that list. The amendments are part of a broader push to promote ease of doing business in the medical device sector.