MEDICAL DEVICE TECHNICAL SPECIFICATION - HSA
MEDICAL DEVICE TECHNICAL SPECIFICATION TS-01: Good Distribution Practice for MEDICAL devices - Requirements Revision 01 SEPTEMBER 2012 MEDICAL DEVICE TECHNICAL SPECIFICATIONS SEPTEMBER 2012 HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP Page 2 of 33 PREFACE This document sets out the requirements for the Good Distribution Practice for MEDICAL devices (GDPMDS). In the event of any contradiction between the contents of this document and any written law, the latter shall take precedence. MEDICAL DEVICE TECHNICAL SPECIFICATIONS SEPTEMBER 2012 HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP Page 3 of 33 1. INTRODUCTION Purpose This document specifies the requirements for the Good Distribution Practice for MEDICAL devices , including secondary assembly activity.
medical device technical specifications september 2012 health sciences authority – health products regulation group page 3 of 33
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