Medical Device Rules 2017
Medical Devices Rules 2017 has already been published vide G.S.R 78(E) dated 31.01.2017 under Drugs and cosmetics Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01.01.2018.
The notified bodies are registered with Central Drugs Standard Control Organisation (CDSCO) under Medical Devices Rules 2017 (MDR 2017) to carry out audit of manufacturing site under the provisions of said rules.
The requirements are laid down in Part I of Third Schedule of Medical Devices Rules, 2017.
The list of the registered Notified bodies with CDSCO is available in the CDSCO website.
The Notified body accredited under sub-rule (1) of Rule 13 shall be competent to carry out an audit of manufacturing sites of Class A and Class B medical devices to verify their conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority.
As per the Medical devices Rules 2017, the National Accreditation Board for
Certification Bodies (NABCB) shall lay down the conformity assessment activities for Accreditation of Notified bodies prior to registration with CDSCO.