DOCUMENTS REQUIRED FOR REGISTRATION OF NOTIFIED B...

DOCUMENTS REQUIRED FOR REGISTRATION OF NOTIFIED BODY, ITS DUTIES AND FUNCTIONS PART I 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.