New Sterilisation Labelling Rule Sparks Concerns Among Device Makers

Medical device manufacturers in India are raising concerns over a recent amendment to the Medical Devices Rules, 2017, introduced by the health ministry. The amendment, announced on August 14, 2026, mandates that devices sterilised at outsourced facilities must have the facility's licence number printed on their labels. This change, which becomes compulsory six months from the notification date, is expected to add to the compliance workload and potentially delay exports, according to industry representatives.

Industry Pushback on New Requirements

The Association of Indian Medical Device Industry (AiMeD) has expressed opposition to the new labelling requirement. The association argues that manufacturers are already burdened with obtaining 'loan licences' for using external sterilisation services such as gamma radiation or ethylene oxide (EO). AiMeD had previously sought an exemption through the Medical Device Technical Advisory Group (MDTAG), but the latest rule introduces additional compliance hurdles.

AiMeD warns that the requirement could complicate export logistics. If the sterilisation facility named on the packaging faces backlogs or becomes unavailable, manufacturers may struggle to substitute another facility, potentially delaying shipments by several weeks. This contrasts with the current system, where delays are typically limited to about a week.

Concerns Over Export and Traceability

The industry body also questions the necessity of including subcontractor details on product labels, emphasizing that manufacturers are ultimately responsible for ensuring quality and traceability. They argue that existing batch-level records already enable effective tracking of the sterilisation process.

Another point of contention is whether the rule will apply to international manufacturers and their sterilisation facilities. AiMeD is seeking clarity on whether these entities will require Indian licences and how the new rule might impact their packaging. Additionally, guidance is sought on handling existing packaging stocks before the rule's implementation.

Government's Position and Industry's Call for Reconsideration

The notification was issued after the government considered feedback on the draft rules and consulted the Drugs Technical Advisory Board. Despite these consultations, AiMeD has urged the government to reconsider the labelling requirement, arguing that patient safety and traceability can be maintained without undermining the competitiveness of Indian manufacturers and their export capabilities.

As the industry braces for the new compliance measure, stakeholders continue to advocate for a balance between regulatory requirements and operational feasibility, emphasizing the need to support the growth and global reach of India's medical device sector.