GHTFSC-AdHoc-RegulatoryModel-April2011-DOC(1.docVIP

GHTF/AHWG-GRM/N1R13:2011 Final Document Title: The GHTF Regulatory Model Authoring Group: Ad Hoc GHTF SC Regulatory Model Working Group Endorsed by: The Global Harmonization Task Force Date: 13 April 2011 [Signature], 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 ? 2011 by the Global Harmonization Task Force The Global Harmonization Task Force Regulatory Model GHTF Ad Hoc Working Group 2011 GHTF/AHWG-GRM/N1R13:2011 __________________________________________________________________________________________________ Date: 13 April 2011Page  PAGE 27 of  NUMPAGES \# 0 \* MERGEFORMAT 27 Table of Contents  TOC \o 1-3 \h \z \u HYPERLINK \l _Toc2902808531 Introduction  PAGEREF _Toc290280853 \h 4 HYPERLINK \l _Toc2902808542 Rationale, Purpose and Scope  PAGEREF _Toc290280854 \h 4 HYPERLINK \l _Toc2902808552.1 Rationale  PAGEREF _Toc290280855 \h 4 HYPERLINK \l _Toc2902808562.2 Purpose  PAGEREF _Toc290280856 \h 5 HYPERLINK \l _Toc2902808572.3 Scope  PAGEREF _Toc290280857 \h 5 HYPERLINK \l _Toc2902808583 Definitions  PAGEREF _Toc290280858 \h 5 HYPERLINK \l _Toc2902808594 Evolution of the GHTF Regulat