For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Amendment 3 to the Asian Harmonization Working Party House Rules”

Submitted by admin on Fri, 11/14/2014 - 17:45


After consolidating the comments received from GHWP members by 6 Nov 2014, the PROPOSED document on "Amendment 3 to the Global Harmonization Working Party House Rules" developed by GHWP Secretariat has become the captioned PROPOSED FINAL document, for endorsement at 19th GHWP Meeting in Seoul.

Thank you for your notice.

For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative"

Submitted by admin on Wed, 11/12/2014 - 17:29


After consolidating the comments received from GHWP members by 17 Oct 2014, the PROPOSED document on "Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative" developed by GHWP WG4 has become the captured PROPOSED FINAL document, for the endorsement at the 19th GHWP Meeting in Seoul.

For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Guidance on Medical Device Quality Management System - Requirements for Distributors"

Submitted by admin on Tue, 11/04/2014 - 18:39


After consolidating the comments received from GHWP members by 3 Apr 2014, the PROPOSED document on "Guidance on Medical Device Quality Management System - Requirements for Distributors " developed by GHWP WG7 has become the captured PROPOSED FINAL document, for the endorsement at the 19th GHWP Meeting in Seoul.

Thank you for your notice.

For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "White Paper on Medical Device Software Regulation - Software Qualification and Classification"

Submitted by admin on Fri, 10/31/2014 - 10:28


After consolidating the comments received from GHWP members by 1 Sep 2014, the PROPOSED document on "White Paper on Medical Device Software Regulation - Software Qualification and Classification" developed by GHWP WG1 has become the captured PROPOSED FINAL document, for the endorsement at the 19th GHWP Meeting in Seoul.

Thank you for your notice.