Medical Device Makers Criticize New Sterilisation Labeling Rule
New labeling rule mandates sterilisation facility license on medical devices, raising industry concerns.
Medical device manufacturers in India are voicing concerns over a new regulation that requires them to list the license number of outsourced sterilisation facilities on their product labels. Announced by the health ministry on August 14, 2026, the amendment to the Medical Devices Rules, 2017, is set to become mandatory six months from the notification date.
Industry Pushback on Compliance Burden
The Association of Indian Medical Device Industry (AiMeD) has expressed opposition to the regulation, arguing that it imposes an unnecessary compliance burden. Manufacturers are currently required to obtain 'loan licenses' when utilizing external facilities for gamma radiation or ethylene oxide (EO) sterilisation. AiMeD contends that the new labeling requirement complicates the process further, potentially affecting export timelines.
According to AiMeD, the rule could lead to delays in shipment, as manufacturers might face difficulties switching sterilisation facilities if the listed facility experiences a backlog or becomes unavailable. The association estimates this could extend shipment times by an additional two to three weeks.
Concerns Over Export and Manufacturing Flexibility
AiMeD has raised questions about the necessity of including subcontractor details on product labels. The association highlights that manufacturers already ensure product quality and traceability through batch-level records, which track the sterilisation process comprehensively.
The industry body is also seeking clarification on whether the rule will apply to foreign manufacturers and their sterilisation facilities. Additionally, they are concerned about how to manage existing packaging inventory before the new requirement takes effect.
Government Consultation and Industry Feedback
The health ministry issued the notification after reviewing objections and suggestions from stakeholders and consulting the Drugs Technical Advisory Board. Despite these consultations, AiMeD continues to urge the government to reconsider the requirement, emphasizing that patient safety and traceability should not come at the cost of compromising the competitiveness of Indian manufacturers and their exports.
The six-month transition period is intended to provide manufacturers with time to adjust to the new rules. However, the industry remains apprehensive about the potential impact on operational efficiency and international trade.