(1) The Central Government shall, by notification, designate any institute, firm or a Government aided or Government organisation as the National Accreditation biotech Highlight biotech Highlight biotech Highlight 11 Body.
(2) The designated National Accreditation Body shall be responsible for carrying out the assessment of such entities who may apply for accreditation as the Notified Body for the purpose of these rules.
(3) The National Accreditation Body referred in sub-rule (1), shall, after carrying out the assessment of the entity which applied for being accredited as a Notified Body under rule 12, issue a certificate to such entity in respect of specified medical devices.
Terms and conditions for National Accreditation Body.
11. The National Accreditation Body shall not act as a Notified Body, and shall,-
(1) identify the conformity assessment activities for accreditation of Notified Bodies and lay down standards for such accreditation;
(2) have a number of competent persons for proper performance of its functions;
(3) prepare norms and procedures for accreditation of Notified Body with the prior approval of the Central Government;
(4) audit the Notified Body periodically for assessing conformance with these rules and the norms laid down by the National Accreditation Body.
Registration process for Notified Body.