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Guidance on Preparation of a Product Registration ... - ASEAN

MEDICAL DEVICE Guidance Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN Common Submission Dossier Template 21 October 2010 Guidance to Common Submission Dossier Template ACCSQ MEDICAL DEVICE Product WORKING GROUP Page 2 of 31 DRAFT PREFACE This document is intended to provide general Guidance . Although we have tried to ensure that the information contained here is accurate, we do not, however, warrant its accuracy or completeness.

and the format that this information is to be submitted in. 1.2. Background The ASEAN CSDT document contains elements of the GHTF guidance document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)” (Document number: SG1/N011R17). The ASEAN …

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