New Sterilisation Labelling Rule Sparks Concern Among Medical Device Makers
Indian medical device manufacturers are concerned about a new rule requiring sterilisation facility licence numbers on labels, fearing export delays and compliance burdens.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has stirred significant concern among medical device manufacturers. The new regulation, announced on August 14, 2026, mandates that manufacturers who outsource sterilisation must include the licence number of the sterilisation facility on their product labels. This requirement is set to become obligatory six months from the date of the notification.
Industry Concerns Over Compliance and Exports
The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to the new labelling rule. The industry body argues that the requirement adds an unnecessary compliance burden on manufacturers who already need to secure 'loan licences' for using external gamma radiation or ethylene oxide (EO) sterilisation services. AiMeD fears this could complicate logistics and lead to significant export delays.
According to AiMeD, the new rule could extend shipment delays to two or three weeks if manufacturers are tied to a specific sterilisation facility that becomes backlogged or unavailable, compared to the current average delay of about a week. The association has also raised questions about the necessity of printing subcontractor details on product labels, considering that manufacturers maintain responsibility for product quality and traceability through existing batch-level records.
Uncertainty Around International Manufacturers
AiMeD has requested clarity on whether international manufacturers and their sterilisation facilities will also be required to obtain Indian licences and adhere to the new labelling requirements. Furthermore, there is concern about how this rule will affect existing packaging stock, as companies will need to adjust their operations within the six-month transition period.
The health ministry issued the notification after reviewing public feedback on the draft rules and consulting with the Drugs Technical Advisory Board. Despite these consultations, AiMeD continues to urge the government to reconsider the new labelling requirement. The group emphasizes that while patient safety and traceability are paramount, these goals should not compromise the competitiveness of Indian manufacturers or disrupt their export activities.
Call for Government Reassessment
As the medical device industry grapples with these changes, AiMeD is advocating for a reassessment of the new rule by the government. The association is pushing for solutions that ensure patient safety and traceability without imposing additional burdens that could hinder the industry's global market presence. The outcome of these discussions could have significant implications for the future operations of medical device manufacturers in India.