Transcription of Guidance Document - CDSCO
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Guidance Document - CDSCO
Guidance Document ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME Page | 1 Guidance Document (Medical Devices Division) Title : Guidance Document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme Doc No : CDSCO /MD/GD/CLAA/01/00 Date : Effective Date : 01st January 2013 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. OF INDIA Guidance Document ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME Page | 2 Table of Contents Content Page No. A. Preface 3-4 B. Requirements for Grant of Licence in form-28 for Manufacture of Medical Devices in India 5-6 1 Covering Letter 5 2 Authorization Letter 5 3 Form 27 5 4 Challan (Fees) 5 5 Constitution Details 5 6 Approved Manufacturing Premises Plan/Layout 6 7 Full particulars of competent and regular technical staff 6 8 Site Master File 6 9 Specific Requirements 6 10 Device Master File 6 11 Product Undertaking by Manufacturer 6 12 ISO 13485:2003 Certificate 6 13 Full Quality Assurance Certificate 6 14 CE Design Examination Certificate 6 15 16 D
The requisite fee as prescribed in the Drugs & Cosmetics Act & Rules viz. Licence fees of Rs.6000/- and an Inspection fees of Rs. 1500/- (Total Rs. 7500/- for 10 items for each category of Device) and additional fees at the
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