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.

[19th AHWP Seoul Meeting] Important Notice on Ebola Virus Disease Quarantine Procedures in Korea

Submitted by admin on Thu, 10/30/2014 - 17:53


Dear all participants of the 19th GHWP Seoul Meeting,

Given the recent concern over the Ebola Virus Disease (EVD) outbreak in West Africa, the Korean government has proposed several quarantine procedures for entry to Korea. Please kindly cooperate for the safety of all participants of the 19th GHWP Seoul Meeting.

Reminder - Please prepare your VISA application for traveling to Seoul, Republic of Korea for the joining of 19th AHWP Meeting

Submitted by admin on Tue, 09/30/2014 - 12:11


The following events will be held back-to-back on 18-21 November 2014:-
- AHC-GHWP Joint Workshop [18-19 Nov]
- 18th GHWP TC Meeting [20 Nov]
- 19th GHWP Annual Meeting [21 Nov]
at the Sheraton Grand Walkerhill Hotel, Seoul, Republic of Korea