Standards for Medical Devices under Medical Devices Rules, 2017 (as amended) issued by CDSCO, Ministry of Health and Family Welfare -reg (English)

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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:- 1. 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. 2. Where 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. 3. In case of the standards which have not been specified under subrule (1) and sub-rule (2), the device shall conform to the validated manufacturer's U-16/30/130/2012-Procell/EquipmentSpecifications-Part(2) I/3421917/2025 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: 1. All Zonal Medical Commissioners. 2. PPS to DG/CVO/FC and PPS to MC(MA)/MC(ME)/MC(MS)/MC(PC). 3. WCM, Hqrs with request for uploading on ESIC website U-16/30/130/2012-Procell/EquipmentSpecifications-Part(2) I/3421917/2025