Medical Device Labels in India To Display Sterilisation Facility License Number

The Ministry of Health and Family Welfare, Government of India has issued the Medical Devices (Second Amendment) Rules, 2026 via notification G.S.R. 743(E) dated 14 August 2026. Under the amendment, medical device labels must now include the license number of the third‑party sterilisation facility if sterilisation is outsourced.

Under Rule 44 a new clause (p) is added which states:

“In case of medical device manufacturer who outsourced the sterilization activity at the site of another facility having valid license to carry out sterilization process of medical devices, the license number of the sterilization site should be mentioned on label of the device. The sterilization site license number by preceding the words “Sterilization sites Manufacturing License Number” or “Ster. Mfg. Lic. No.” or “S.M. L.” 5. In the said rules, in the clause (o) of Rule 44, after the words “and (m)”, shall be substituted by the words, “(m) and (p).”

The requirement becomes mandatory six months from the date of the notification (14 August 2026). This finalises the draft notification G.S.R. 270(E) published on 10 April, 2026

This amendment introduces an additional compliance requirement on the medical device manufacturers raising concerns in the industry. A medical device is already packed and labelled with the device manufacturer’s licence number and other statutory requirements like expiry date or shelf life before being sent for sterilisation (typically by Ethylene Oxide (ETO) or Gamma radiation) to outsourced facilities. No further packing and labelling activities are performed after sterilisation. The new amendment makes it difficult for manufacturers to switch sterilisation facilities at short notice in case the planned facility is not available due to rush or other technical issues.

References:

• Gazette Notification (G.S.R 743(E) – Medical Devices (Second Amendment) Rules, 2026
• CDSCO: Medical Devices Rules, 2017 (31 January 2017, G.S.R 78(E)