Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
Please refer to the below attached with more information.
Thank you
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
Please refer to the below attached with more information.
Thank you
Guidance on Regulatory Practices for Combination Products
Please refer to the below attached with more information.
Thank you
Guidance on Medical Device Quality Management System - Requirements for Distributors
Please refer to the below attached with more information.
Thank you
Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative
Please refer to the below attached with more information.
Thank you.
Asian Harmonization Working Party Strategic Framework Towards 2020 - “The Foreseeable Harmonization Horizon”
Please refer to the below attached with more information.
Thank you.
Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change
Please refer to the below attached with more information.
Thank you.
(WG3 here is referred to WG7 after the restructuring of work groups.)
Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative
Please refer to the below attached with more information.
Thank you.
(WG2 here is referred to WG4 after the restructuring of work groups.)
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
Please refer to the below attached with more information.
Thank you.
(WG1a here is referred to WG2 after the restructuring of work groups.)
Essential Principles of Safety and Performance of IVD Medical Devices
Please refer to the below attached with more information.
Thank you.
(WG1a here is referred to WG2 after the restructuring of work groups.)