Annoucement: AHWPTC Work Group Training Session will be held on 19 Nov 2014

Announcement: Latest Agenda for the AHC-AHWP Joint Workshop, the 18th AHWPTC Meeting and the 19th AHWP Annual Meeting, 18-21 Nov 2014

For endorsement at the 19th AHWP Meeting-PROPOSED FINAL document on "Comparison between the Common Submission Dossier Template (CSDT) format and the GHTF Summary Technical Documentation (STED) formats for In Vitro Diagnostic Medical Devices"

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

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"

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

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