New Sterilisation Label Rule Sparks Concerns Among Device Makers
India's health ministry mandates sterilisation facility licence numbers on medical device labels, raising compliance concerns.
The Indian health ministry has introduced a new regulation requiring medical device manufacturers to include the licence number of outsourced sterilisation facilities on their product labels. This amendment to the Medical Devices Rules, 2017, was announced in a notification on August 14, 2026, and will be enforced from February 2027.
Industry Concerns Over Compliance and Export Delays
The Association of Indian Medical Device Industry (AiMeD) has expressed concerns about the new labelling requirement. Manufacturers argue that this rule could increase compliance burdens and impact their ability to meet export timelines. The association highlighted that manufacturers already need to obtain 'loan licences' for using external sterilisation methods like gamma radiation or ethylene oxide (EO).
According to AiMeD, the new requirement might complicate logistics, especially if the specified sterilisation facility faces backlogs or becomes unavailable. Such situations could potentially delay shipments by two to three weeks, compared to the current delay of about a week.
Calls for Exemptions and Clarity
AiMeD has called for exemptions through the Medical Device Technical Advisory Group (MDTAG) and questioned the necessity of printing subcontractor details on product labels. Manufacturers emphasize that they are accountable for quality and traceability, with existing batch-level records already offering sufficient tracking of the sterilisation process.
The industry body is also seeking clarification on whether the rule will apply to international manufacturers and their sterilisation facilities, and how existing packaging stock should be managed before the new rule takes effect.
Government Response and Transition Period
The health ministry's notification includes a six-month transition period. This decision was made after considering objections and suggestions on the draft rules and consulting the Drugs Technical Advisory Board. Despite the concerns, the government aims to ensure patient safety and traceability without compromising the competitiveness of Indian manufacturers.
AiMeD has urged the government to reconsider the requirement, emphasizing the need for a balance between regulatory compliance and the operational realities faced by manufacturers in the global market.