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2023-06-05T07:11:18
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The National Accreditation Body referred to in sub-rule (1), shall, after carrying out the assessment of the e

The National Accreditation Body referred to in sub-rule (1), shall, after carrying out the assessment of the entity which applied for accreditation, issue a certificate to such entity in respect of specified categories of standards for which such entity has been assessed and found qualified: PROVIDED that where the entity has been found not possessing the requisite qualification and other requirements, the National Accreditation Body, shall reject the application. (5) The National Accreditation Body shall not act as a Notified Body. 12. Functions of National Accreditation Body The National Accreditation Body shall, — (a) lay down the conformity assessment activities for accreditation of Notified Bodies and lay down standards for such accreditation; (b) prepare norms and procedures for accreditation of Notified Body; (c) audit a Notified Body periodically for assessing conformance with these rules and the norms laid down by it. 13. 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 Page 14 of 248 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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