India amends medical device rules to ease regulatory compliance

India’s Ministry of Health and Family Welfare has amended the Medical Devices Rules, 2017, to streamline regulatory processes and promote the Ease of Doing Business in the healthcare technology sector.

Key reforms include the removal of the requirement for manufacturers to obtain a separate loan licence when outsourcing sterilisation to a facility that already holds a valid licence. To maintain traceability, manufacturers must now include the sterilisation facility’s licence number on the device label, with a six-month transition period provided for compliance.

Additionally, the government has added the European Union to the list of recognised stringent regulatory jurisdictions. This allows medical devices approved in the EU to benefit from waivers regarding clinical investigation requirements for devices without existing predicates in India. The amendments also introduce a Ninth Schedule to establish a standardised and transparent fee structure for medical device testing across laboratories.

While the government aims to reduce administrative burdens and accelerate market access for innovative technologies, some industry representatives, such as the Association of Indian Medical Device Industry (AiMeD), have expressed concerns that new labelling mandates could impact export shipment timelines.