October 26th, 2010 Page 3 of 23 Essential Principles of Safety and Performance of Medical Devices Study Group 1 Document GHTF/SG1(PD)/N68R05 1 Introduction The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe ...
(USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use ...
/Directives/DirectiveList.asp European Medical Device Directive Guidance documents: Canadian Medical Devices Regulations: http://laws.justice.gc.ca/en/f-27/sor-98-282/126598.html Australian Medical Devices Regulations: .au/html/pastereg/3/1762/top.htm Global Harmonization Task Force: Japan MHLW: ...
The guidance contained within this document is intended to apply to medical devices generally and the device component of combination products. It is not intended to cover IVDDs. 3 References GHTF final documents SG1/N012:2000 SG1/N029:2005 SG1/N040:2006 SG1/N041:2005 Role of Standards in ...
NOTE 2 The manufacturer’s responsibilities are described in other GHTF guidance documents. They include a responsibility to ensure pre- and post-market regulatory requirements for a finished medical device are met. This includes adverse event reporting and notification of corrective actions. NOTE 3 “...
GHTF SG1 Definitions of the Terms Manufacturer :GHTF SG1的定义的条款制造商of,制造,sg,GHTF,SG1,the,Terms,terms,ghtf,GHTF 文档格式: .doc 文档大小: 82.0K 文档页数: 7页 顶/踩数: 0/0 收藏人数: 1 评论次数: 0 文档热度: 文档分类:
bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentan...
IVD Medical Devices – the GHTF Guidance DocumentsTang, Shelley
GHTF/SG1/N063:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices Authoring Group: Study Group 1 of the Global Harmonization Tas...
Safety and Performance of Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/N011:2008 1.0 Introduction The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe a global regulatory model for medical devices....