India mandates sterilisation facility licence number on medical device labels
The Ministry of Health and Family Welfare has mandated that medical device manufacturers that outsource sterilisation must disclose the licence number of the facility carrying out the process on the labels of their devices. The move, announced through a gazette notification dated August 14, 2026, amends Rule 44 of the Medical Devices Rules, 2017, and is aimed at strengthening traceability and accountability in the medical device sector.
Under the amended provision, in cases where a manufacturer outsources sterilisation to another facility holding a valid licence for the process, the licence number of the sterilisation site must be mentioned on the device label. The requirement will become mandatory six months after the notification. Sterilisation involves eliminating or reducing microbial contamination to ensure medical devices are safe for use in healthcare settings, and the government says the measure will help identify the facility responsible for this critical process.
Industry concerns over compliance and exports
The Association of Indian Medical Device Industry (AiMeD) has opposed the move, saying manufacturers are already being asked to obtain “loan licences” for using external gamma radiation or ethylene oxide (EO) sterilisation facilities. The industry had sought an exemption through the Medical Device Technical Advisory Group (MDTAG), but the new labelling requirement has instead added another compliance burden, according to AiMeD.
Rajiv Nath, forum coordinator of AiMeD, said the requirement could create particular difficulties for export shipments by limiting manufacturers’ ability to shift production between approved sterilisation facilities based on turnaround time and available capacity. “Depending on cobalt strength and backlog, shipments could be delayed by two to three weeks, instead of being dispatched within a week,” Nath said.
AiMeD argued that quality and traceability are generally placed on manufacturers in global regulatory frameworks, with documentation maintained by companies providing batch-level accountability. The association claimed that no other jurisdiction requires subcontractor details to be printed on medical device packaging, and said the requirement could put Indian manufacturers at a competitive disadvantage in international markets.
Industry seeks clarity on implementation
The industry body has sought clarity on whether overseas manufacturers and their sterilisation facilities will also need Indian licences and whether the requirement will apply to their packaging. It has also asked how manufacturers should handle existing packaging stock before the new requirement takes effect.
The notification provides a six-month transition period and was issued after the government considered objections and suggestions and consulted the Drugs Technical Advisory Board. AiMeD has urged the government to reconsider the requirement, saying patient safety and traceability should be ensured without affecting the competitiveness of Indian manufacturers and their exports.
The latest amendment came nearly a year after the Central Drugs Standard Control Organisation (CDSCO) informed drug authorities across states and Union Territories that a loan licence may not be required for medical technology companies outsourcing sterilisation to a facility holding a valid licence for the process.