Medical Device Makers Concerned Over New Sterilisation Labelling Rule
A new rule mandates medical device labels to include sterilisation facility licence numbers, sparking compliance concerns.
Medical device manufacturers are expressing concerns over a recent amendment to the Medical Devices Rules, 2017, which mandates the inclusion of the licence number of outsourced sterilisation facilities on product labels. This requirement, announced by the health ministry on August 14, 2026, will come into effect six months from the notification date.
Compliance and Export Challenges
The Association of Indian Medical Device Industry (AiMeD) has voiced apprehensions regarding the new regulation. The organisation argues that the additional labelling requirement imposes an undue compliance burden on manufacturers, potentially complicating export processes. AiMeD notes that the necessity to specify a particular sterilisation facility on labels could hinder manufacturers from switching providers in cases of backlog or unavailability, potentially delaying shipments by up to three weeks.
Manufacturers have previously been required to secure 'loan licences' for using external sterilisation methods such as gamma radiation or ethylene oxide (EO) facilities. AiMeD has requested exemptions through the Medical Device Technical Advisory Group (MDTAG), but the new rule has added another layer of compliance requirements instead.
Industry Requests for Clarity
The industry body is seeking clarification on several points, including whether overseas manufacturers and their sterilisation facilities will need to obtain Indian licences and if the rule will apply to their packaging. Additionally, manufacturers are looking for guidance on managing existing packaging stock before the regulation becomes mandatory.
AiMeD argues that the current system already ensures quality and traceability through batch-level records, making the printing of subcontractor details on products unnecessary. They are urging the government to reconsider the rule to maintain the competitiveness of Indian manufacturers in the global market without compromising patient safety and traceability.
Government's Position
The notification, issued after considering objections and suggestions from stakeholders and consulting the Drugs Technical Advisory Board, provides a six-month transition period for manufacturers to comply. The health ministry maintains that the amendment is part of an ongoing effort to enhance transparency and traceability within the medical device industry.
As the compliance deadline approaches, industry players continue to advocate for modifications to the regulation, emphasizing the need to balance regulatory compliance with operational flexibility and export efficiency.