Medical device makers flag new sterilisation labelling rule
The health ministry, in a notification dated August 14, 2026, amended the Medical Devices Rules, 2017, requiring manufacturers that outsource sterilisation to a licensed facility to include the facility's licence number on the device label. The requirement will become mandatory six months after the notification.
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- Medical device makers to soon face Facility audits; Test-Licence waiver on cards: DCGI health.economictimes.indiatimes.com