ESIC circular U-16/30/130/2012-Procell/EqpSpec-Part(2)/E-792399 · 01 Jan 2026
Official title
Standards for Medical Devices under Medical Devices Rules, 2017 (as amended) issued by CDSCO, Ministry of Health and Family Welfare -reg (English)
Official record
Open source pageSummary
The Employees' State Insurance Corporation mandates that all ESIC medical institutions adhere to product standards for medical devices. These standards follow the Medical Devices Rules, 2017, and subsequent amendments. Institutions must ensure that all procured medical equipment conforms to standards set by the Bureau of Indian Standards. If no such standard exists, devices must meet International Organization for Standardization or International Electro Technical Commission requirements. If these standards are also unavailable, devices must conform to validated manufacturer standards. Deans, Medical Superintendents, and Institutional Heads must ensure strict compliance with these requirements during all procurement processes.
What you must do
Key dates
Who is affected
U-16/30/130/2012-Procell/EqpSpec-Part(2)/E-792399 31-12-2025 To All Deans - ESIC PGIMSRs, Medical & Dental Colleges and Hospitals All Medical Superintendents - ESIC Hospitals Director (Medical) Delhi/Director (Medical) Noida
Subject: Standards for Medical Devices under Medical Devices Rules, 2017 (as amended) issued by CDSCO, Ministry of Health and Family Welfare -reg. Ref: MDR 2017, notification dt 31/01/2017 and As amended vide GSR 777(E) dt. 14-10-2022 (Copies enclosed) Respected Sir/Madam, With reference to the subject cited above, I am directed to refer to Rule 7 of the Medical Devices Rules (MDR), 2017, issued by CDSCO, Ministry of Health and Family Welfare vide notification dated 31.01.2017, and as amended from time to time, including notification dated 14.10.2022 (copies enclosed) wherein product standards for medical device have been specified as under:-
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. This issues with the approval of the Competent Authority. Yours sincerely,
Asst. Director (PC) Encl: As above Copy to:
U-16/30/130/2012-Procell/EquipmentSpecifications-Part(2) I/3421917/2025
