News | AHWP

Asian Harmonization Working Party (AHWP) preannounces change of organization name to Global Harmonization Working Party (GHWP)

New Logo of GHWP

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Annoucement: AHWP Playbook is now available on the website

We are glad to announce that the AHWP Playbook for Implentation of Medical Device Regulatory Frameworks is now available on the website. This playbook is developed to provide guidelines and reference tools to guide member economies in development of their medical device regulatory framework.

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Announcement: New AHWP and AHWPTC Leadership have been elected for the term 2015-2017

We are pleased to announce that the new AHWP and AHWPTC Leadership of 2015-2017 have been elected during the 19th AHWP Annual Meeting in Nov 2014. Please refer to the link: http://54.255.218.20/node/30 for the message of the newly elected AHWP Chair, Dr. Hee-Kyo Jeong.

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Agenda (Final) for the 17th AHWP Meeting, AHWP TC Meeting and Workshop on 2nd - 6th Nov 2012 in Chinese Taipei

Dear all participants,

Please kindly find the final agenda for your information.

Thank you very much.

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

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

Thank you for your notice.

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For resolution at the 17th AHWP Meeting in Chinese Taipei - PROPOSED FINAL document on "Amendment 2 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference"

After consolidating the comments received from AHWP members by 31 Oct 2012, the PROPOSED document on "Amendment 2 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference" developed by AHWP Secretariat has become the captioned PROPOSED FINAL document, for resolution at 17th AHWP Meeting in Chinese Taipei.

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For endorsement at the 17th AHWP Meeting in Chinese Taipei - PROPOSED FINAL documents on "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1 - 5)"

After consolidating the comments received from AHWP members by 31 Oct 2012, the PROPOSED document on "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1 - 5)" developed by AHWP WG4 has become the captioned PROPOSED FINAL document, for endorsement at 17th AHWP Meeting in Chinese Taipei.

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For endorsement at the 17th AHWP Meeting in Chinese Taipei - PROPOSED FINAL document on "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions"

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For endorsement at the 17th AHWP Meeting in Chinese Taipei - PROPOSED FINAL document on "Medical Device Adverse Event (AE) Report Form"

After consolidating the comments received from AHWP members by 31 Oct 2012, the PROPOSED document on "Medical Device Adverse Event (AE) Report Form" developed by AHWP WG2 has become the captioned PROPOSED FINAL document, for endorsement at 17th AHWP Meeting in Chinese Taipei.

Thank you for your notice.

Read more about For endorsement at the 17th AHWP Meeting in Chinese Taipei - PROPOSED FINAL document on "Medical Device Adverse Event (AE) Report Form"