New Sterilisation Label Rule Sparks Concerns Among Device Makers

India's medical device industry is grappling with a recent amendment to the Medical Devices Rules, 2017, issued by the health ministry on August 14, 2026. The notification requires manufacturers who outsource sterilisation processes to display the licence number of the sterilisation facility on their product labels. This new labelling mandate is set to become compulsory six months from the date of notification.

Industry Concerns Over Compliance and Export Delays

The Association of Indian Medical Device Industry (AiMeD) has voiced its opposition to the regulation, citing increased compliance burdens and potential delays in export shipments. The association argues that manufacturers are already required to obtain 'loan licences' for using external sterilisation services, such as gamma radiation or ethylene oxide (EO) facilities. Adding the necessity to print facility licence numbers on labels could further complicate logistics, especially when switching facilities due to capacity issues or backlogs.

AiMeD claims that the new requirement could extend shipment delays from one week to as much as three weeks. The industry body also questions the necessity of including subcontractor details on the packaging, emphasizing that manufacturers maintain responsibility for product quality and traceability, which is already ensured through batch-level records.

Clarification Sought on International Compliance

In addition to addressing domestic concerns, AiMeD has requested clarification regarding the applicability of these rules to international manufacturers and their sterilisation facilities. The association is particularly interested in understanding whether foreign entities will need to comply with Indian licensing requirements and how these rules will affect their packaging standards.

The notification provides a six-month transition period for manufacturers to adapt to the new labelling requirements. This follows a consultation process involving the Drugs Technical Advisory Board, where objections and suggestions on the draft rules were considered. Despite this, AiMeD is urging the government to reconsider the implementation, arguing that patient safety and traceability can be maintained without imposing additional burdens on manufacturers, which could impact their competitive edge, particularly in export markets.

The industry awaits further guidance from the government on how to manage existing packaging inventory before the new regulations come into force, as well as on other operational specifics of the rule.