India proposes amendments to medical device rules to ease regulations

India's Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to simplify regulatory requirements and promote ease of doing business in the medical device sector. The proposed changes, announced on August 24, 2026, aim to reduce administrative burdens, cut compliance costs, and facilitate faster market access for eligible medical devices. A key amendment to Rule 44 eliminates the need for manufacturers to obtain a separate loan licence when outsourcing sterilization to a facility that already holds a valid licence under the Medical Devices Rules, 2017.