上市後监督-英文.pdf

GHTF/SG2/N79R11:2009 FINAL DOCUMENT Title: Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form Authoring Group: Study Group 2 Endorsed by: The Global Harmonization Task Force Date: February 17, 2009 Roland Rotter, GHTF Chair The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance 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 © 2000 by the Global Harmonization Task Force Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form: GHTF/SG2/N79R11:2009 Study Group 2 – Final Document ___________________________________________________________________________ Table of Contents 1. Scope 4 2. References 4 3. Definitions 4 4. Reporting Guidance 6 5. National Competent Authority Report (NCAR 7 6. Instructions for Filling in National Competent Authority Report 9 7. Report Exchange Method 12 __________________________________________________________________________________________ February 2009