Adoption of "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions"

Submitted by admin on Fri, 11/23/2012 - 19:35


During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions".

Please refer to the below attached with more information. 

Thank you.

Adoption of "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1 - 5)"

Submitted by admin on Fri, 11/23/2012 - 19:29


During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1-5)".

Please refer to the below attached with more information. 

Thank you.

(WG4 is referred to WG6 after the restructuring of work groups.)

For resolution at the 17th AHWP Meeting in Chinese Taipei - PROPOSED FINAL document on "Amendment 1 to the Asian Harmonization Working Party House Rule"

Submitted by admin on Thu, 11/01/2012 - 14:45


After consolidating the comments received from GHWP members by 31 Oct 2012, the PROPOSED document on "Amendment 1 to the Global Harmonization Working Party House Rule" developed by GHWP Secretariat has become the captioned PROPOSED FINAL document, for resolution at 17th GHWP Meeting in Chinese Taipei.

Thank you for your notice. 

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