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. Previously, manufacturers had to secure this additional licence even when the contracted sterilization facility was fully licensed. The government stated that removing this duplication will reduce paperwork and administrative burden, particularly benefiting manufacturers without their own sterilization facilities. However, a traceability requirement has been retained; manufacturers must now print the sterilization facility's licence number on the medical device label. A six-month transition period has been provided for companies to update their labelling and packaging processes.