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(ii) Directors, executives and personnel responsible for carrying out evaluation and verification activities shall be independent of both the manufacturers for whom the notified body conducts assessments and the commercial competitors of those manufacturers, during their employment by the notified body for the product range it is notified for. (iii) Notified body personnel shall not be involved in consultancy activities relating to devices in question, their manufacturing control or test procedures, or their manufacturer. PART II 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.
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