Medical device makers oppose new sterilisation labelling rule

Medical device manufacturers have objected to a new health ministry rule requiring them to print the licence number of an outsourced sterilisation facility on device labels. The Association of Indian Medical Device Industry (AiMeD) said the requirement adds compliance burden and could delay exports by two to three weeks if the named facility is unavailable.

The health ministry's notification dated August 14, 2026 amends the Medical Devices Rules, 2017. The rule will become mandatory six months after notification. AiMeD had sought an exemption through the Medical Device Technical Advisory Group but said the new rule instead adds another requirement. The industry body has also sought clarity on whether overseas manufacturers need Indian licences and how to handle existing packaging stock.

The government said it considered objections on the draft rules and consulted the Drugs Technical Advisory Board before issuing the notification. AiMeD urged the government to reconsider, stating patient safety and traceability can be ensured without harming Indian manufacturers' competitiveness.