IVD Medical Devices – the GHTF Guidance DocumentsTang, Shelley
Evaluation,Guidance GHTF医疗器械临床评价是在 医疗器械安 全与性能基本要求 体系框架下建立的评价体系。 临床评价开始之前,需对照安全与性能基本要求 特征判定列表,鉴别哪些安全和/或性能需要临 床相关数据支持,依据其确定临床评价范围。通 过数据鉴别、数据评价、数据分析的过程最终形 成临床评价报告,而临床评价报告和...
(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 ...
production of a series of guidance documents that together describe a global regulatory model for medical devices, including In Vitro Diagnostic (IVD) medical devices. The purpose of such guidance is to harmonize the documentation and procedures that are used to assess whether a medical device, incl...
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 ...
Clause 5. Medical Device Directive, Council Directive 93/42/EEC, Annex I; including all amendments up to 5 Sep 2007 (2006/42/EC) to Medical Devices. COCIR Document, Joint Industry Recommendation, Guidance on the applicability of EHSR of the Machinery Directive, Document No. 62A A1PMT (Bruss...
(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 re strictions on the reproduction, distribution or ...
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....
series of guidance documents that together describe a global regulatory model for medical devices. The purpose of such guidance is to harmonize the documentation and procedures that are used to assess whether a medical device conforms to the regulations that apply in ...
This document providesguidance in relation to: i)the circumstances where a post-market clinical follow-up study is indicated; ii)the general principles of post-market clinical follow-up studies involving medical devices; and iii)the use of study information, including, for example, to provide info...