Principles of Conformity Assessment for Medical Devices 医疗器械合格评定原则.docx

GHTF/SG1/N78:2012FINAL DOCUMENTGlobal Harmonization Task Force(Revision of GHTF/SG1/N40:2006)Title: Principles of Conformity Assessment for Medical DevicesAuthoring Group: Study Group 1 of the Global Harmonization Task ForceEndorsed by: The Global Harmonization Task Force Date: November 2nd, 2012Dr. Kazunari Asanuma, GHTF Chair This document was produced by the Global Harmonization Task Force, a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (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 of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.Copyright ? 2012 by the Global Harmonization Task ForceTable of Contents1.0Introduction42.0Rationale, Purpose and Scope42.1Rationale42.2Purpose52.3Scope53.0References54.0Definitions65.0Conformity Assessment Elements75.1Quality management system (QMS)85.2System for post-marketing surveillance105.3Technical documentation105.4Declaration of conformity115.5Registration of manufacturers and their medical devices by the Regulatory Authority116.0Harmonized Conformity Assessment System126.1The relationship between conformity assessment and device classification126.2Conformity assessment system126.3Conformity assessment considerations16PrefaceThe document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device Regulatory Authorities and the regulated industry. The document is intended to provide non-binding guidance for use in