Medical Device Makers Challenge New Sterilisation Labelling Mandate

Indian medical device manufacturers are raising alarms over a recent amendment to the Medical Devices Rules, 2017, requiring them to include the licence number of outsourced sterilisation facilities on product labels. This regulation, announced by the health ministry on August 14, 2026, is set to become mandatory six months from the notification date.

Industry Concerns Over Increased Compliance

The Association of Indian Medical Device Industry (AiMeD) has voiced significant concerns, suggesting that the new requirement could exacerbate compliance challenges and potentially delay export timelines. Manufacturers argue that this additional labelling requirement could result in logistical hurdles, particularly if the designated sterilisation facility encounters delays or backlogs.

Currently, manufacturers must secure 'loan licences' to utilise external gamma radiation or ethylene oxide (EO) sterilisation services. AiMeD has argued that the new rule imposes an additional burden without enhancing safety or traceability. The organisation has appealed for exemptions through the Medical Device Technical Advisory Group (MDTAG), but the recent amendment suggests these requests have not been met.

Potential Impact on Exports

The new regulation could impact export activities, with AiMeD warning that shipments might face delays extending to two to three weeks, compared to the previous one-week delay. This is particularly concerning if manufacturers are unable to switch to alternative sterilisation facilities due to labelling commitments.

AiMeD has further questioned the necessity of printing the subcontractor's details on the products, given that manufacturers are already accountable for quality and traceability with batch-level documentation. The industry body is seeking clarity on whether foreign manufacturers and their sterilisation facilities will be required to comply with Indian licensing and labelling standards.

Seeking Government Reconsideration

The notification, which comes after consultations with the Drugs Technical Advisory Board, allows a six-month transition period. Despite this, AiMeD is urging the government to reconsider the new rule, emphasizing that patient safety and product traceability can be maintained without compromising the competitiveness of Indian manufacturers in the global market.

The association is also requesting guidance on managing existing packaging stocks before the rule takes effect, as well as clarification on how overseas entities will be impacted.