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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 Declaration of Conformity Any other approval 6 6 C Annexures 7-43 Annexure I List of State Licensing Authorities 8-13 Annexure II List of CDSCO Zonal/Sub Zonal off

notified medical devices (Under CLAA Scheme) are being uploaded for the information of all stakeholders. The document is intended to provide guidance for use in the manufacture of notified medical devices for sale in India. This guidance document will be effective from 1st January 2013. The common submission format may be used even before

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STEPS TO BE FOLLOWED BY THE MANUFACTURERS/ …

www.cdsco.gov.in

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www.cdsco.gov.in

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