Regulatory Changes Spark Concerns Among Medical Device Manufacturers
India's new sterilisation labelling rule could hinder device exports, say industry leaders.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has prompted concerns from medical device manufacturers. The notification, issued on August 14, 2026, mandates that manufacturers outsourcing sterilisation must include the licence number of the sterilisation facility on their product labels. This requirement will become mandatory six months from the notification date.
Industry Pushback on New Labelling Requirement
The Association of Indian Medical Device Industry (AiMeD) has voiced its opposition to the new regulation. The group argues that the requirement adds another layer of compliance for manufacturers, who are already required to obtain 'loan licences' for using external sterilisation methods such as gamma radiation or ethylene oxide (EO). AiMeD has requested an exemption through the Medical Device Technical Advisory Group (MDTAG), but the new rule has instead increased the compliance burden.
The association warns that the regulation could disrupt export operations. Manufacturers may face delays if the sterilisation facility named on the packaging is unable to meet demand or faces backlogs, potentially extending shipment times from one week to up to three weeks.
Concerns Over Export and Traceability
AiMeD questions the necessity of including the subcontractor's details on product labels, noting that manufacturers are already responsible for quality control and traceability. Current batch-level records sufficiently track the sterilisation process, the association argues.
Further clarity is sought on whether overseas manufacturers and their sterilisation facilities will need Indian licences and if the labelling requirement applies to their products. AiMeD also inquires about handling existing packaging stock before the new rule's enforcement.
Government's Position and Transition Period
The health ministry's notification includes a six-month transition period to allow manufacturers to adjust to the new requirements. This decision followed the consideration of objections and suggestions on the draft rules, as well as consultations with the Drugs Technical Advisory Board.
AiMeD urges the government to reconsider the regulation, emphasizing that patient safety and traceability should be achieved without compromising the competitiveness of Indian manufacturers in the global market.