New Sterilisation Labelling Rule Sparks Concerns Among Device Makers

Medical device manufacturers in India are voicing concerns over a fresh regulation introduced by the health ministry that mandates the inclusion of sterilisation facility licence numbers on product labels. The amendment to the Medical Devices Rules, 2017, was officially notified on August 14, 2026, and will become compulsory six months thereafter.

Compliance Burdens and Export Implications

The Association of Indian Medical Device Industry (AiMeD) has expressed apprehension about the rule, arguing that it could exacerbate compliance challenges for manufacturers who already need to secure 'loan licences' for utilising external sterilisation services like gamma radiation or ethylene oxide (EO) sterilisation. AiMeD warns that the requirement could lead to export delays, as manufacturers may face obstacles if the sterilisation facility listed on the packaging is unavailable or faces backlogs. According to the association, this could extend shipment delays to two to three weeks from the current one-week timeframe.

Industry Seeks Clarifications and Exemptions

The industry body has called for exemptions through the Medical Device Technical Advisory Group (MDTAG), emphasizing that quality and traceability are already maintained via batch-level records. AiMeD has also requested clarification on whether international manufacturers and their sterilisation facilities will need to comply with Indian licensing requirements and how existing packaging stocks should be handled before the rule takes effect.

Government's Stance and Stakeholder Feedback

The health ministry's notification followed a period of consultation with the Drugs Technical Advisory Board and consideration of feedback on the draft rules. While the government aims to enhance traceability and patient safety with this regulation, AiMeD has urged a reevaluation to balance these goals with the competitiveness of Indian manufacturers in the global market.