Notified body (1) Any institute, organisation or body corporate may seek accreditation, after notification of these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner as may be determined by the National Accreditation Body from time to time. (2) The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of Class A 2 [(other than non-sterile and non-measuring)] and Class B medical devices to verify conformance with the Quality Management System and other Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority.
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