GHTF GHTF SG2 - Reporting Errors Medical Devices By Manufacturer - February 2003 - PDF (622kb)

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GHTF SG2 - Reporting Errors Medical Devices By Manufacturer - February 2003 - PDF (622kb)[附网盘链接]由The Global Harmonization Task Force于当前发布,适用于全球范围。

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GHTF SG2 - Reporting Errors Medical Devices By Manufacturer - February 2003 - PDF (622kb)[附网盘链接]
GHTF SG2 - Reporting Errors Medical Devices By Manufacturer - February 2003 - PDF (622kb)[附网盘链接](截图)

 

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GHTF

FINAL DOCUMENT

Title: Medical Device Postmarket Vigilance and Surveillance:

Proposal for Reporting of Use Errors with Medical Devices by their

Manufacturer or Authorized Representative

Authoring Group: Study Group 2

Endorsed by: The Global Harmonization Task Force

Date: February 2003

丁问k )向伊

Taisuke H外o, GHTF Chair

The document herein was produced by the Global Harmonization Task Force, a voluntary group 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.

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