New Sterilisation Labelling Rule Sparks Concerns Among Device Makers

In a recent regulatory update, the Indian health ministry has introduced a new requirement for medical device manufacturers to display the licence number of outsourced sterilisation facilities on product labels. The amendment, dated August 14, 2026, modifies the Medical Devices Rules, 2017, and will become mandatory after a six-month transition period.

Industry Concerns Over Compliance and Delays

Manufacturers have expressed concerns that the new rule could increase compliance burdens and potentially delay exports. The Association of Indian Medical Device Industry (AiMeD) has voiced opposition, noting that the industry is already subject to stringent regulations, including the need for 'loan licences' for using external sterilisation facilities like gamma radiation or ethylene oxide (EO).

According to AiMeD, manufacturers had requested an exemption through the Medical Device Technical Advisory Group (MDTAG). However, the new labelling requirement could hinder flexibility, as companies may face logistical challenges if the listed sterilisation facility experiences backlogs or becomes unavailable. This could extend shipment delays from one week to as much as three weeks.

Traceability and Export Implications

AiMeD has questioned the necessity of printing subcontractor details on device packaging. The association argues that manufacturers already ensure quality and traceability through batch-level records, which track the sterilisation process. The industry body is seeking clarification on whether the rule will also apply to overseas manufacturers and their sterilisation facilities, and how it might affect packaging for exports.

Another point of concern is the handling of existing packaging stock before the new rule comes into effect. AiMeD has urged the government to provide clear guidelines on this issue to prevent unnecessary waste and logistical complications.

Government's Response and Industry's Call for Reconsideration

The health ministry issued the notification after reviewing objections and suggestions from various stakeholders and consulting the Drugs Technical Advisory Board. The six-month transition period is intended to allow manufacturers time to comply with the new requirement.

Despite the government's efforts to address industry concerns, AiMeD has called for a reconsideration of the rule. The association argues that while patient safety and traceability are paramount, they should not come at the expense of the competitiveness of Indian manufacturers in the global market.