The Ministry of Health and Family Welfare has mandated medical device manufacturers that outsource sterilisation to mention the licence number of the sterilisation facility on their device labels.
The government amended Rule 44 of the Medical Devices Rules, 2017, through a gazette notification. The requirement applies when manufacturers use another licensed facility for sterilisation.
Strengthening Traceability
The move aims to improve traceability and accountability by identifying the facility responsible for the critical sterilisation process. Sterilisation helps eliminate or reduce microbial contamination and ensures that medical devices are safe for healthcare use.
As per IBTimes, however, domestic medical device manufacturers have raised concerns that the requirement could increase their compliance burden, particularly for export shipments.
Industry Raises Concerns
The Association of Indian Medical Device Industry (AiMeD) has warned that the rule could limit manufacturers’ flexibility to switch between approved sterilisation facilities based on capacity and turnaround time. The industry body also said that delays could affect exports and make Indian manufacturers less competitive internationally.
The amendment follows earlier regulatory steps that allowed medical device companies to outsource sterilisation to licensed third-party facilities without requiring a separate loan licence. The latest requirement seeks to strengthen oversight while improving transparency across the medical device supply chain.