Medical device makers flag new sterilisation labelling rule

Medical device manufacturers are voicing concerns over a new government rule mandating the inclusion of the licence number of an outsourced sterilisation facility on device labels. The health ministry implemented the amendment to the Medical Devices Rules, 2017 on August 14, 2026, making the requirement mandatory six months later.

The Association of Indian Medical Device Industry (AiMeD) has opposed the move, arguing that it adds to the already heavy compliance burden for manufacturers. Many have already sought exemptions through the Medical Device Technical Advisory Group (MDTAG), but AiMeD claims this new rule introduces yet another burden.

AiMeD warns that the rule could impede exports, as manufacturers may struggle to switch sterilisation facilities if there are backlogs or unavailability at the named facility. This could extend shipping delays from about a week to two to three weeks. The industry body questions the necessity of printing the subcontractor details on the product, asserting that manufacturers are already accountable for quality and traceability via batch-level records.

AiMeD has requested clarification on whether overseas manufacturers and their facilities would also need Indian licences, as well as how existing packaging stock should be managed before the new requirement takes effect. The notification includes a six-month transition period and was released after the government reviewed objections and suggestions on the draft rules.

AiMeD urges the government to reconsider the requirement, emphasizing that patient safety and traceability can be ensured without compromising the competitiveness of Indian manufacturers and their exports.