List of available standards of Bureau of Indian Standards for Medical Devices

Public Notice: No. 31026/83/2021-MD
Dated 1st February 2022

Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals

Public Notice dated 01.02.2022

Subject: List of available standards of Bureau of Indian Standards for Medical Devices — regarding

I am directed to refer to Rule 7 of Medical Device Rules, 2017 as under, which stipulates the requirement of Product Standards for medical devices :-

“Product standards for medical device —

1. The medical device shall conform to the standards laid down by the Bureau of Indian Standards established wider 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 clown under sub-rule (1), such device shall conform to the standard laid down by the International Organisation far Standardisation (1S0) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia!
3. In case of the standards which have not been specified under sub-rule (I) and sub-rule (2), the device shall conform to the validated manufacturer’s “