Medical device makers flag new sterilisation labelling rule

NEW DELHI: Medical device manufacturers have raised concerns over a new government rule requiring companies to print the licence number of an outsourced sterilisation facility on device labels, saying it could add to compliance burden and delay exports.The health ministry, in a notification dated August 14, 2026, amended the Medical Devices Rules, 2017, requiring manufacturers that outsource sterilisation to a licensed facility to mention its licence number on the device label. The requirement will become mandatory six months after the notification.The Association of Indian Medical Device Industry (AiMeD) has opposed the move, saying manufacturers are already being asked to obtain “loan licences” for using external gamma radiation or ethylene oxide (EO) sterilisation facilities.AiMeD said manufacturers had sought an exemption through the Medical Device Technical Advisory Group (MDTAG), but the new labelling requirement has instead added another compliance burden.The association said the rule could affect export shipments, as manufacturers may not be able to switch to another sterilisation facility if the one named on the packaging has a backlog or is unavailable. It claimed this could delay shipments by two to three weeks, compared with about a week earlier.AiMeD also questioned the need to print the subcontractor's details on the product, saying manufacturers remain responsible for quality and traceability, with batch-level records already allowing the sterilisation process to be tracked.The industry body has sought clarity on whether overseas manufacturers and their sterilisation facilities will also need Indian licences and whether the requirement will apply to their packaging.It has also sought clarity on how manufacturers should handle existing packaging stock before the new requirement takes effect.The notification provides a six-month transition period and was issued after the government considered objections and suggestions received on the draft rules and consulted the Drugs Technical Advisory Board.AiMeD has urged the government to reconsider the requirement, saying patient safety and traceability should be ensured without affecting the competitiveness of Indian manufacturers and their exports.