Medical Device Industry Challenges New Sterilisation Labeling Rule

India's medical device manufacturers are expressing significant concerns over a newly introduced government regulation mandating the inclusion of license numbers of outsourced sterilisation facilities on device labels. The amendment to the Medical Devices Rules, 2017, announced by the health ministry on August 14, 2026, requires compliance within six months.

Industry Concerns Over Compliance and Export Delays

The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to the rule, highlighting the additional compliance burden it places on manufacturers. According to AiMeD, the requirement could complicate the logistics of exporting medical devices, as companies may face delays if they cannot promptly switch sterilisation facilities due to backlogs or other issues. These delays could extend shipment times from the current one week to two to three weeks.

AiMeD argues that manufacturers are already tasked with obtaining 'loan licenses' for using external sterilisation services, such as gamma radiation or ethylene oxide (EO) facilities. The new labeling requirement adds another layer of regulation without necessarily improving patient safety or traceability, as manufacturers maintain rigorous batch-level records for tracking sterilisation processes.

Calls for Clarification and Exemptions

The industry body has called for clarification on several fronts, including whether the rule applies to overseas manufacturers and their facilities, and how existing packaging stock should be handled before the new regulation takes effect. AiMeD has sought exemptions through the Medical Device Technical Advisory Group (MDTAG) but has yet to see changes to the rule.

AiMeD is urging the government to reconsider this requirement, emphasizing that while patient safety and traceability are paramount, they should not come at the cost of the competitiveness of Indian manufacturers, particularly in the export market. The association has proposed that the government explore alternative methods to achieve the same objectives without imposing additional burdens on the industry.

Transition Period and Government Consultation

The notification, which includes a six-month transition period, was issued after the government reviewed objections and suggestions on the draft rules and consulted with the Drugs Technical Advisory Board. The health ministry believes the new regulation will enhance transparency and accountability in the sterilisation process, but the industry remains concerned about its practical implications.

As the deadline approaches, manufacturers are keenly watching for any potential adjustments to the rule or additional guidance from the health ministry that could mitigate the impact on their operations.