Medical Device Firms Challenge New Sterilisation Labelling Mandate
India mandates sterilisation facility licence numbers on medical device labels, raising compliance concerns.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has stirred up concerns among medical device manufacturers. The new regulation, announced on August 14, 2026, mandates that companies outsourcing sterilisation must include the licence number of the sterilisation facility on their product labels. This requirement will become compulsory six months from the date of notification.
Industry Concerns Over Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to this new rule, arguing that it imposes an additional compliance burden on manufacturers. According to AiMeD, companies are already required to obtain 'loan licences' for using external sterilisation facilities, such as those employing gamma radiation or ethylene oxide (EO).
AiMeD has highlighted that the new labelling requirement could disrupt export processes. Manufacturers may face delays if the sterilisation facility named on the packaging is backlogged or unavailable, potentially extending shipment times by two to three weeks compared to the current one-week delay.
Questions on Implementation and International Impact
The industry association also raised questions about the necessity of printing subcontractor details on product labels, given that manufacturers are already responsible for maintaining quality and traceability through batch-level records. AiMeD has requested clarification on whether international manufacturers and their sterilisation facilities will need to comply with Indian licensing requirements and how the rule will affect packaging.
Additionally, there are concerns about managing existing packaging stock before the new rule is enforced. AiMeD has urged the government to reconsider the requirement, emphasizing the need to balance patient safety and traceability with the competitiveness of Indian manufacturers in the global market.
Government Consultation and Industry Feedback
The health ministry's notification follows consultations with the Drugs Technical Advisory Board and consideration of feedback on draft rules. The six-month transition period is intended to allow manufacturers time to adjust to the new requirements. However, AiMeD remains firm in its stance that the rule could hamper the efficiency and competitiveness of the industry, especially in terms of exports.
As the deadline approaches, stakeholders in the medical device industry are seeking further dialogue with the government to address these concerns and ensure that the regulation supports both safety and industry growth.