New Sterilisation Labelling Rule Sparks Concern Among Device Makers
Medical device manufacturers worry new labelling rules could hinder exports and add compliance burdens.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has sparked concerns among medical device manufacturers. The amendment, notified on August 14, 2026, mandates that manufacturers outsourcing sterilisation must include the sterilisation facility's licence number on device labels. This requirement will become compulsory six months after the notification.
Industry Pushback Against New Rule
The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to this new rule, arguing that it adds an unnecessary compliance burden. Manufacturers are already required to obtain 'loan licences' for using external sterilisation facilities, such as gamma radiation or ethylene oxide (EO) sterilisation. AiMeD claims that this new labelling requirement could delay exports, as manufacturers may face challenges if the named facility on the packaging has a backlog or becomes unavailable, potentially extending shipment delays from one week to up to three weeks.
Concerns Over Export and Compliance
The industry body questioned the necessity of printing subcontractor details on product labels, highlighting that manufacturers remain accountable for quality and traceability. They argue that batch-level records already allow for effective tracking of the sterilisation process. AiMeD has called for clarification on whether international manufacturers and their sterilisation facilities will require Indian licences and whether these requirements will extend to their packaging.
Regulatory Transition and Industry Feedback
The notification provides a six-month transition period, during which the government considered objections and suggestions received on the draft rules. AiMeD has urged the government to reconsider the requirement, emphasizing that patient safety and traceability should be ensured without compromising the competitiveness of Indian manufacturers in the global market.
Additionally, AiMeD seeks guidance on managing existing packaging stock before the new rule takes effect. The association insists that the new rule should not affect the ability of Indian manufacturers to export their products efficiently.