New Sterilisation Labelling Rule Sparks Concerns Among Device Makers
A new rule requiring sterilisation facility licence numbers on medical device labels raises compliance and export concerns.
The Indian health ministry's recent amendment to the Medical Devices Rules, 2017, mandating that the licence number of outsourced sterilisation facilities be included on device labels, has drawn criticism from industry stakeholders. Announced on August 14, 2026, the rule will take effect six months from the notification date, creating a significant compliance challenge for manufacturers.
Industry Concerns Over Compliance and Exports
The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to the new rule, arguing that it imposes an additional compliance burden on manufacturers. The requirement to include the licence number of sterilisation facilities on product labels could complicate logistics, especially for exports. AiMeD warns that the inability to switch to another sterilisation facility in the event of a backlog could delay shipments by up to three weeks, compared to the current delay of about a week.
Manufacturers have been seeking exemptions through the Medical Device Technical Advisory Group (MDTAG), but the new rule instead introduces further compliance hurdles. AiMeD argues that the existing system already ensures quality and traceability through batch-level records, questioning the necessity of printing subcontractor details on the packaging.
Implications for International Manufacturers
AiMeD has called for clarity on whether international manufacturers and their sterilisation facilities will need to adhere to Indian licensing requirements. There is also concern about how the new rule will affect existing packaging stock, which may not comply with the updated labelling requirements.
The notification was issued after the government reviewed objections and suggestions from stakeholders and consulted the Drugs Technical Advisory Board. Despite this, AiMeD is urging the government to reconsider the rule, advocating for patient safety and traceability without compromising the competitiveness of Indian manufacturers.
Transition Period and Industry Response
The six-month transition period provided by the notification is meant to allow manufacturers to adjust to the new requirements. However, AiMeD remains concerned about the potential for disruption, particularly in export markets. The association is calling for a balance between regulatory compliance and operational flexibility to ensure Indian manufacturers remain competitive globally.
The health ministry's decision has sparked a debate on how best to balance regulatory requirements with industry needs. As the deadline approaches, manufacturers are closely monitoring developments and seeking further guidance from the government to navigate the new compliance landscape effectively.