Call for Comments

CALL FOR COMMENTS on the PROPOSED document "Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices”

CALL FOR COMMENTS on the PROPOSED document "Comparison between the GHTF Summary Technical Documentation (STED) formats for Medical Devices and In Vitro Diagnostic Medical Devices and the Common Submission Dossier Template (CSDT) format”

CALL FOR COMMENTS on the PROPOSED document "Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative"

News!!!!!! CALL FOR COMMENTS on the PROPOSED document "Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange"

News!!!!!! CALL FOR COMMENTS on the PROPOSED document "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1 - 5)"

News!!!!!! CALL FOR COMMENTS on the PROPOSED document "Amendment 1 to the Asian Harmonization Working Party House Rules"

News!!!!!! CALL FOR COMMENTS on the PROPOSED document "Amendment 2 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference"