The Employees State Insurance Corporation (ESIC), on December 31, 2025, notified regarding the Standards for Medical Devices under Medical Devices Rules, 2017 (as amended) issued by CDSCO.
The following has been stated namely:-
• The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
• There no relevant standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia standards.
• All Deans / Medical Superintendents / Institutional Heads are requested to ensure strict compliance and adherence to the prescribed product standards for medical devices, as notified under the Medical Devices Rules, 2017 and amendments thereof, in all matters relating to procurement of equipment/medical device in their respective institutions.
[Notification no. U-16/30/130/2012-Procell/EqpSpec-Part(2)/E-792399]
