New Sterilisation Labelling Rule Raises Concerns Among Medical Device Makers
Medical device firms express concerns over new rules requiring sterilisation facility licence numbers on labels, citing potential export delays.
The Indian Health Ministry's recent amendment to the Medical Devices Rules, 2017, has prompted concerns among medical device manufacturers. The amendment, dated August 14, 2026, mandates that companies outsourcing sterilisation must include the licence number of the sterilisation facility on the device labels. This requirement becomes compulsory six months from the notification date.
Industry Concerns Over Compliance and Export Delays
The Association of Indian Medical Device Industry (AiMeD) has voiced opposition to the new rule. The organization argues that this additional labelling requirement could exacerbate compliance burdens and potentially delay export processes. Manufacturers are already required to obtain 'loan licences' for using external sterilisation facilities, such as those employing gamma radiation or ethylene oxide (EO).
AiMeD representatives have highlighted that the new rule might impede manufacturers' ability to switch between sterilisation providers, particularly if the designated facility faces a backlog. Such constraints could extend shipment delays to two or three weeks, compared to the usual one-week delay.
Calls for Clarity and Exemptions
In response to the notification, AiMeD has sought clarity on several fronts. It is unclear whether the rule applies to international manufacturers and their sterilisation facilities, and how existing packaging stock should be handled before the rule takes effect. The industry body has emphasized that manufacturers are already responsible for quality and traceability, with existing batch-level records providing sufficient tracking of the sterilisation process.
The association has urged the government to reconsider the requirement, arguing that while patient safety and traceability are paramount, these should not come at the cost of the competitiveness of Indian manufacturers in the global market.
Government's Stance and Industry Feedback
The Health Ministry's decision followed consultations with the Drugs Technical Advisory Board and a review of feedback on draft rules. The ministry has provided a six-month transition period for manufacturers to comply with the new labelling requirement.
As the deadline looms, industry stakeholders continue to engage with policymakers to find a balance between regulatory compliance and operational efficiency. The evolving dialogue underscores the tension between regulatory mandates and the practicalities of manufacturing and exporting medical devices.