Medical Device Industry Challenges New Sterilisation Labelling Rule
The new rule mandates labeling of sterilisation facility licence numbers, sparking compliance concerns.
The Indian health ministry has introduced a new amendment to the Medical Devices Rules, 2017, which requires medical device manufacturers outsourcing sterilisation to licensed facilities to include those facilities' licence numbers on their product labels. The amendment, notified on August 14, 2026, will become mandatory six months from the notification date, prompting industry concerns over increased compliance burdens and potential export delays.
Industry Concerns Over Compliance and Exports
The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to this new requirement. The group argues that manufacturers are currently obligated to obtain 'loan licences' for using external sterilisation methods, such as gamma radiation or ethylene oxide (EO) processes. The addition of facility licence numbers on labels is seen as an extra compliance step that could complicate logistics and delay export shipments.
According to AiMeD, the rule could hinder manufacturers' ability to switch sterilisation facilities quickly if unforeseen issues or backlogs occur, potentially extending shipment delays from one week to up to three weeks. This, they argue, could negatively impact the international competitiveness of Indian medical device manufacturers.
Calls for Clarity and Reconsideration
AiMeD has requested clarification from the government on several points, including whether overseas manufacturers and their sterilisation facilities will need Indian licences and if the requirement applies to their packaging. The association also seeks guidance on managing existing packaging stock before the new rule takes effect.
The notification follows a period of public consultation, where the government reviewed objections and suggestions regarding the draft rules, with input from the Drugs Technical Advisory Board. Despite these consultations, AiMeD is urging the government to reconsider the rule, emphasizing that patient safety and product traceability should not come at the expense of industry competitiveness.
The six-month transition period offers some time for adjustment, but AiMeD stresses the need for a balanced approach that maintains stringent safety and traceability standards without overburdening manufacturers.