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Union of India - Section

Section 11 in The Medical Devices Rules, 2017

11. National Accreditation Body.

(1)The Central Government may, by notification, designate such institute, firm or a Government aided or Government organization, which fulfills the criteria specified from time to time by the Government, as the National Accreditation Body:Provided that the National Accreditation Board for Certification Bodies under the Quality Council of India, registered under the Societies Registration Act, 1860 (21 of 1860) set up by the Ministry of Commerce and Industry in the Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies referred to in rule 13, till such time any other body for the purpose is notified, with immediate effect.
(2)The National Accreditation Body shall have the required number of competent persons for proper performance of its functions
(3)The designated National Accreditation Body referred to in sub-rule (1) shall be responsible for carrying out the assessment of such entities who may apply for accreditation to become a Notified Body for the purpose of these rules.
(4)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.