Medical Device Makers Challenge New Sterilisation Label Rule
Device makers oppose new rule to label outsourced sterilisation facility licence numbers, citing compliance burdens.
The Indian health ministry has introduced a rule mandating medical device manufacturers to include the licence numbers of outsourced sterilisation facilities on their product labels. This amendment to the Medical Devices Rules, 2017, was notified on August 14, 2026, and will become compulsory six months from this date.
Industry Concerns Over Compliance
The Association of Indian Medical Device Industry (AiMeD) has expressed significant concerns about the new regulation, arguing that it imposes additional compliance burdens. Manufacturers currently using external gamma radiation or ethylene oxide (EO) sterilisation facilities are already required to obtain 'loan licences'. AiMeD suggests that this new requirement complicates the process further without enhancing safety or traceability.
Industry representatives argue that the necessity to label the subcontractor's licence number could delay export processes. As manufacturers may not switch facilities easily if the current one is backlogged, this could extend shipment times by several weeks.
Call for Clarity and Flexibility
AiMeD has requested further clarification from the government regarding the applicability of this rule to international manufacturers and whether their sterilisation facilities require Indian licensing. Moreover, there is a need for guidance on handling existing packaging stock before the new rule takes effect.
The association has also raised concerns about the practical implications for international trade and competitive positioning. They argue that while patient safety and traceability are crucial, these should not be achieved at the expense of competitive disadvantages for Indian manufacturers.
Government's Response and Transition Period
The government provided a six-month transition period for the industry to adapt to the new requirements. This decision followed consultations with the Drugs Technical Advisory Board and consideration of feedback on the draft rules. Despite industry pushback, the health ministry maintains that the rule is essential for enhancing the traceability and accountability of medical devices.
AiMeD continues to urge the government to reconsider the requirement, seeking a solution that balances regulatory needs with the business realities faced by manufacturers.