Under the Medical Devices (Second Amendment) Rules, 2026, manufacturers that outsource sterilisation to another facility holding a valid sterilisation licence will no longer need a separate loan licence for the outsourced sterilisation activity. However, the sterilisation facility’s licence number must be displayed on the medical device label. The labelling requirement will become mandatory six months after notification.

The amendment also introduces a formal definition of “Certificate of Registration” under the rules and establishes a Ninth Schedule prescribing standardised fees for medical device testing and evaluation, aimed at improving transparency and predictability in regulatory processes.

Separately, through the Medical Devices (Third Amendment) Rules, 2026, the government has amended Rule 63 to include European Union countries alongside the United States, United Kingdom, Australia, Canada and Japan. This enables eligible medical devices approved by EU regulators to benefit from the applicable waiver of clinical investigation requirements for devices without predicate devices in India.

The amendments were notified through G.S.R. 743(E) and G.S.R. 744(E) and published in the Official Gazette on August 19, 2026, following consideration of stakeholder feedback and consultation with the Drugs Technical Advisory Board.

The regulatory changes are expected to reduce compliance requirements and approval-related delays for manufacturers while strengthening traceability of outsourced sterilisation and facilitating faster access to eligible innovative medical devices from recognised international regulatory markets.

The move is part of the government’s broader effort to streamline India’s medical device regulatory framework while maintaining requirements related to the quality, safety and performance of medical devices.