Indian Medical Device Industry Challenges New Sterilisation Rule

Medical device manufacturers in India are expressing concerns over a recent amendment to the Medical Devices Rules, 2017, announced by the health ministry on August 14, 2026. The amendment mandates that manufacturers who outsource sterilisation must include the licence number of the sterilisation facility on the device label. This new requirement is set to become compulsory six months from the date of notification.

Industry Pushback on Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to the new rule, citing increased compliance burdens and potential export delays. According to AiMeD, manufacturers already face the requirement to obtain 'loan licences' for using external gamma radiation or ethylene oxide (EO) sterilisation facilities. The association argues that the additional labelling requirement could further complicate logistics and delay shipments by up to three weeks, compared to the current one-week delay.

AiMeD has also raised questions about the necessity of printing subcontractor details on product labels, arguing that manufacturers already maintain responsibility for quality and traceability. They point out that batch-level records are sufficient for tracking the sterilisation process, making the new rule redundant.

Concerns Over International Compliance and Existing Stock

Another concern for the industry is the potential impact on international operations. AiMeD has requested clarification on whether overseas manufacturers and their sterilisation facilities will be required to obtain Indian licences and comply with the new packaging rules. Furthermore, there is uncertainty about how manufacturers should handle existing packaging stock that does not comply with the new requirement.

The health ministry's notification provides a six-month transition period, which was decided upon after considering objections and suggestions from the draft rules and consulting the Drugs Technical Advisory Board. However, AiMeD has urged the government to reconsider the rule, emphasizing the need to ensure patient safety and traceability without compromising the competitiveness of Indian manufacturers in the global market.

Call for Reassessment

AiMeD is advocating for a reassessment of the rule, suggesting that the government should find a balance that maintains both safety standards and the export efficiency of Indian medical device manufacturers. The association argues that the new rule, as it stands, could hinder the industry's ability to swiftly respond to market demands and maintain its competitive edge internationally.