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"

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

CALL FOR COMMENTS on the PROPOSED document "Amendment 3 to the Asian Harmonization Working Party House Rules"