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DUTIES AND
2023-09-11T05:02:14
Accredited Consultants Pvt Ltd
DUTIES AND FUNCTIONS OF NOTIFIED BODY1. Duties:1. Notified body shall perform the audit of manufacturer who

DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the audit of manufacturer who applied under sub-rule (1) of rule 13. The specific application shall be allotted to the notified body by the State Licensing Authority through the portal of the Central Government. The audit shall relevant to domestic manufacturing site of Class A 38[(other than non-sterile and non-measuring)] or Class B medical devices. 2. The notified body shall have standard operating procedure for identification, review and resolution of all cases where conflict of interest is suspected or proven. Record of such review and decision shall be maintained. 2. Functions: A notified body shall, — (i) impart training to its staff covering all the evaluation and verification operations for which the notified body has been designated; (ii) ensure that staff has adequate knowledge and experience of the requirem ent of the control; (iii) carry out the evaluation and verification operations with the highest degree of professional integrity independently with technical competence;

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