Medical Device Firms Challenge New Sterilisation Labelling Mandate
India's new rule mandates device makers list sterilisation facility's license on labels, sparking industry concerns.
The Indian health ministry has introduced a new regulation requiring medical device manufacturers to disclose the license number of any outsourced sterilisation facility on their product labels. This amendment to the Medical Devices Rules, 2017, was announced on August 14, 2026, and will become compulsory six months from the notification date.
Industry Concerns Over Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has voiced significant concerns about this new requirement, indicating it could increase compliance burdens and potentially delay export timelines. Manufacturers currently using external gamma radiation or ethylene oxide (EO) sterilisation facilities must already obtain "loan licences." The new rule adds another layer of compliance, according to AiMeD.
AiMeD argues that the mandate could affect export operations, as manufacturers might face difficulties if the designated sterilisation facility experiences backlogs or becomes unavailable. This situation could extend shipment delays to two to three weeks, compared to the previous one-week delay.
Call for Exemptions and Clarity
The industry body has requested exemptions through the Medical Device Technical Advisory Group (MDTAG) and is seeking clarity on several issues. These include whether international manufacturers and their sterilisation processes must comply with Indian licensing requirements, and how to manage existing packaging stock before the rule's implementation.
AiMeD questions the necessity of printing subcontractor details on product labels, arguing that manufacturers are already accountable for quality and traceability through batch-level records. The association has urged the government to reconsider the rule to maintain competitiveness without compromising patient safety and traceability.
Government's Response and Transition Period
The health ministry has provided a six-month transition period for compliance, following consultations with the Drugs Technical Advisory Board and consideration of objections and suggestions to the draft rules. The ministry's decision aims to enhance traceability and ensure safety in the medical device supply chain.