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(Medical Devices Division) - Central Drugs Standard ...

GUIDANCE DOCUMENT ON COMMON SUBMISSION format FOR REGISTRATION/RE-REGISTRATION OF. NOTIFIED medical Devices . Guidance Document ( medical Devices division ). Title : Guidance Document on Common Submission format for Registration/ Re-Registration of Notified medical Devices in India Doc No. : CDSCO/MD/GD/RC/01/00. st Date : 31 October 2012. st Effective : 1 January 2013. Date Central Drugs Standard CONTROL ORGANIZATION. DIRECTORATE GENERAL OF HEALTH SERVICES. MINISTRY OF HEALTH & FAMILY WELFARE. GOVT. OF INDIA. Page | 1. GUIDANCE DOCUMENT ON COMMON SUBMISSION format FOR REGISTRATION/RE-REGISTRATION OF. NOTIFIED medical Devices . Table of Contents Sr. No. Content Page No. A. Preface 3-4. B. Requirements for Common Submission format 5-7. for Registration of medical Devices in India 1 Covering Letter 5. 2 Authorization Letter 5. 3 Form 40 5. 4 TR6 Challan 5. 5 Power of Attorney 6. 6 Wholesale License 7. 7 Free Sale Certificate 7. 8 ISO 13485:2003 Certificate 7.

GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR REGISTRATION/RE-REGISTRATION OF NOTIFIED MEDICAL DEVICES. Page | 1 Guidance Document (Medical Devices Division)

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