DOCUMENTS TO BE FURNISHED ALONG WITH APPLICATION IN FORM MD-1 FOR GRANT OF CERTIFICATE OF REGISTRATION 1. A Notified Body shall furnish duly signed copy of the following documents to the Central Licensing Authority. (i) Constitution details of the Notified Body; (ii) Brief profile of the organization and business profile related to audit of medical device manufacturing sites; (iii) Accreditation Certificate issued by the National Accreditation Body referred to in rule 11; (iv) Quality manual of the organization; (v) List of all Standard Operating Procedures; (vi) List of all technical personnel including any outside experts along with their qualification, experience and responsibilities. 2. Undertaking to be submitted stating that the, — (i) Notified body including its directors, executives and personnel responsible for carrying out evaluation and verification activities shall not be the designer, manufacturer, supplier or installer of devices within the product category for which the body has been designated, nor the authorised representative of any of those parties. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 94 of 248 (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.