New Sterilisation Labelling Rule Concerns Medical Device Makers

The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, has sparked concerns among medical device manufacturers. The amendment, issued on August 14, 2026, mandates that manufacturers outsourcing sterilisation to licensed facilities must include the facility's licence number on device labels. This requirement becomes mandatory six months post-notification.

Industry Concerns Over New Compliance Burden

The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to the new rule, arguing it adds to the existing compliance burden for manufacturers. According to the association, these companies are already required to obtain 'loan licences' for using external sterilisation methods like gamma radiation or ethylene oxide (EO). AiMeD fears the new labelling requirement may lead to export delays, as manufacturers could face logistical challenges if the specified sterilisation facility is unavailable or backlogged, potentially extending shipment times by two to three weeks.

Need for Clarity and Exemptions

AiMeD has called for exemptions and sought clarity on several aspects of the new rule. This includes whether overseas manufacturers and their sterilisation facilities will need Indian licences and if the rule applies to their packaging. Additionally, there is uncertainty about how manufacturers should manage existing packaging stock before the rule's enforcement.

The notification, which allows a six-month transition period, was issued following consultations with the Drugs Technical Advisory Board and consideration of feedback on the draft rules. Despite this, AiMeD argues that patient safety and traceability could be maintained without hampering the competitiveness of Indian manufacturers and their exports.

Government Response and Industry's Next Steps

While the government has yet to respond to AiMeD's concerns, the association continues to urge a reconsideration of the requirement. It advocates for a balance that ensures patient safety and product traceability without imposing additional burdens that could affect market dynamics and export efficiency.

This development highlights the ongoing tension between regulatory compliance and industry operations, as stakeholders navigate the complexities of international and domestic market requirements.