Work Group 1
| Document No. | Description | Date | Document |
|
GHWP/WG1-WG2-WG3/F002:2023 |
Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) | 30 Nov 2023 |  Download file: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) |
| GHWP/WG2-WG1-WG3/F001:2023 | Categorisation of Changes to a Registered Medical Device | 16 Feb 2023 | Download file: Categorisation of Changes to a Registered Medical Device.pdf |
|
GHWP/WG2-WG1-WG3/F001:2021 |
Regulatory Mechanism for Medical Devices Including In Vitro Diagnostic Medical Devices and Software as Medical Devices During A Public Health Emergency | 1 Dec 2021 | Download file: Regulatory Mechanism for Medical Devices Including In Vitro Diagnostic Medical Devices and Software as Medical Devices During A Public Health Emergency.pdf |
| AHWP/WG1/F002:2020 |
Handbook for Approval of Patient-matched Medical Devices Using 3D Printers |
17 Nov 2020 |
Download file: Handbook for Approval of Patient-matched Medical Devices Using 3D Printers.pdf |
| AHWP/WG1/F001:2020 |
Guidance for Minor Change Reporting |
17 Nov 2020 |
|
|
AHWP/WG2-WG1-WG3/F001:2019 |
Categorisation of Changes to a Registered Medical Device | 3 Dec 2019 |
|
|
AHWP/WG1-WG2-WG3/F002:2019 |
Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) | 2 Dec 2019 |
|
|
AHWP/WG1-WG2/F001: 2017 |
Regulation and treatment of e-IFU and e-Label of Medical Devices-Review of International Practice | 31 Dec 2017 | |
|
AHWP/WG1/F001:2016 |
Guidance on Regulatory Practices for Combination Products | 26 Nov 2016 |
|
|
AHWP/WG2-WG1/F001:2016 |
Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device” |
26 Nov 2016 | Download file: Definition of the Terms "Medical Device" and "In Vitro Diagnostic (IVD) Medical Device".pdf |
| AHWP/WG1/F001:2015 |
Guidance for Preparation of a Common Submission Dossier Template Dossier for Genera Medical Device |
6 Nov 2015 |
|
|
AHWP/WG1/F002:2015 |
White Paper on Regulation of Combination Products - A review of International Practice |
6 Nov 2015 |
|
|
AHWP/WG2_WG1/F001:2015 |
Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device' |
6 Nov 2015 |
|
|
AHWP/WG1/F001:2014 |
White Paper on Medical Device -Software Qualification and Classification White Paper |
21 Nov 2014 | Download file:Final_GHWP_WG1_F001_ 2014.pdf |
Work Group 2
| Document No. | Description | Date | Document |
| GHWP/WG2/F001:2023 | Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices | 30 Nov 2023 | Download file: Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices |
| GHWP/WG1-WG2-WG3/F002:2023 | Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU | 30 Nov 2023 | Download file: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) |
| GHWP/WG2-WG1-WG3/F001:2023 | Categorisation of Changes to a Registered Medical Device | 16 Feb 2023 | Download file: Categorisation of Changes to a Registered Medical Device.pdf |
| GHWP/WG2 /F001:2021 | Replacement Reagent and Instrument Family Policy | 1 Dec 2021 | Download file: Replacement Reagent and Instrument Family Policy.pdf |
| GHWP/WG2-WG5/F001:2021 | Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices | 1 Dec 2021 | Download file: Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices.pdf |
| GHWP/WG2-WG1-WG3/F001:2021 | Regulatory Mechanism for Medical Devices Including In Vitro Diagnostic Medical Devices and Software as Medical Devices During A Public Health Emergency | 1 Dec 2021 | Download file: Regulatory Mechanism for Medical Devices Including In Vitro Diagnostic Medical Devices and Software as Medical Devices During A Public Health Emergency.pdf |
|
AHWP/WG2-WG1-WG3/F001:2019 |
Categorisation of Changes to a Registered Medical Device | 3 Dec 2019 |
|
|
AHWP/WG1-WG2-WG3/F002:2019 |
Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) | 2 Dec 2019 |
|
| AHWP/WG2/F001:2018 | Labelling for In Vitro Diagnostic Medical Devices | 25 Oct 2018 | Download file: Labelling for In Vitro Diagnostic Medical Devices.pdf |
|
AHWP/WG1-WG2/F001: 2017 |
Regulation and treatment of e-IFU and e-Label of Medical Devices-Review of International Practice | 31 Dec 2017 | |
|
AHWP/WG2/F001:2017 |
Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medical Devices | 4 Sep 2017 | |
|
AHWP/WG2/F001:2016 |
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | 26 Nov 2016 |
|
|
AHWP/WG2/F002:2016 |
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices |
26 Nov 2016 |
|
|
AHWP/WG2/F003:2016 |
Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices |
26 Nov 2016 |
|
|
AHWP/WG2-WG1/F001:2016 |
Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device” |
26 Nov 2016 |
|
|
AHWP/WG2_WG1/F001:2015 |
Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device' |
6 Nov 2015 |
|
|
AHWP/WG2/F001:2014 |
Comparison between CSDT and STED IVDDs |
21 Nov |
|
|
AHWP/WG2-WG8/F002:2014 |
Role of Standards in the Assessment of Medical Devices |
21 Nov 2014 |
|
|
AHWP/WG1a/F004:2013 |
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
|
6 Dec 2013 |
|
|
AHWP/WG1a/F002:2013 |
Essential Principles of Safety and Performance of IVD Medical Devices |
6 Dec 2013 |
|
|
AHWP/WG1a/F001:2013 |
GHWP Regulatory Framework for IVD Medical Devices |
6 Dec 2013 |
Work Group 3
| Document No. | Description | Date | Document |
| GHWP/WG1-WG2-WG3/F002:2023 | Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) | 30 Nov 2023 | Download file: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) |
| GHWP/WG2-WG1-WG3/F001:2023 | Categorisation of Changes to a Registered Medical Device | 16 Feb 2023 | Download file: Categorisation of Changes to a Registered Medical Device.pdf |
| GHWP/WG2-WG1-WG3/F001:2021 | Regulatory Mechanism for Medical Devices Including In Vitro Diagnostic Medical Devices and Software as Medical Devices During A Public Health Emergency | 1 Dec 2021 | Download file: Regulatory Mechanism for Medical Devices Including In Vitro Diagnostic Medical Devices and Software as Medical Devices During A Public Health Emergency.pdf |
|
AHWP/WG2-WG1-WG3/F001:2019 |
Categorisation of Changes to a Registered Medical Device | 3 Dec 2019 |
|
|
AHWP/WG1-WG2-WG3/F002:2019 |
Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU) | 2 Dec 2019 |
|
|
AHWP/WG3/F001:2016 |
Guidance document on Risk Categorisation of Software as a Medical Device |
26 Nov 2016 |
|
|
AHWP/WG3/F001:2015 |
Guidance Document on Medical Device Software - Qualification and Classification |
6 Nov 2015 | Download file:GHWP-WG3_Guidance document on Medical Device Software_FINAL.pdf |
Work Group 4
| Document No. | Description | Date | Document |
| GHWP/WG4/F001:2023 | Post Market Resource Center | 25 Nov 2023 | Download file: Post Market Resource Center |
|
AHWP/WG4/F001:2016 |
Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative |
26 Nov 2016 | Download file: Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer of its Authorized Representative.pdf |
|
AHWP/WG4/F002:2016 |
Post Market Resource Center | 26 Nov 2016 | |
|
AHWP/WG4/F003:2016
|
GHWP Safety Alert Dissemination System (SADS) | 26 Nov 2016 | Download file: FINAL_GHWP-WG4-SADS_Draft(20161117).pdf |
| AHWP/WG4/F001:2015 |
Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representatives |
6 Nov 2015 |
|
|
AHWP/WG4/F001:2014 |
Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative |
21 Nov |
|
|
AHWP/WG2/F001:2013 |
Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative |
6 Dec 2013 |
|
|
AHWP/WG2/F002:2012 |
Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions |
20 Nov 2012 |
|
|
AHWP/WG2/F001:2012 |
Medical Device Adverse Event (AE) Report Form |
20 Nov 2012 |
|
|
AHWP/WG2/SADS/002 |
Safety Alert Dissemination System: Safety Alert Dissemination |
23 January 2008 |
|
|
AHWP/WG2/SADS/001 |
Framework for GHWP Safety Alert Dissemination System (SADS) |
23 January 2008 | GHWP_WG2_SADS_001.pdf |
Work Group 5
| Document No. | Description | Date | Document |
| AHWP/WG2-WG5/F001:2021 | Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices | 1 Dec 2021 |
|
|
AHWP/WG5/F002:2017 |
Post Market Clinical Follow-Up Studies | 6 Dec 2017 | |
|
AHWP/WG5/F001:2017 |
Clinical Investigation | 6 Dec 2017 | |
| AHWP/WG5/F001:2015 | Clinical Evaluation | 6 Nov 2015 | |
| AHWP/WG5/F002:2015 |
Clinical Evidence for Medical Device - Key Definitions and Concepts |
6 Nov 2015 |
|
|
AHWP/WG5/F003:2015 |
Clinical Evidence for IVD Medical Device - Key Definitions and Concepts |
6 Nov 2015 |
|
|
AHWP/WG5/F004:2015 |
Clinical Evidence for IVD Medical Devices- Scientific Validity Determination and Performance Evaluation |
6 Nov 2015 | Download file:GHWP-WG5_Clinical Evidence for IVD medical devices-Scientific Validity Determination_FINAL.pdf |
Work Group 6
| Document No. | Description | Date | Document |
|
AHWP/WG6/F001:2016 |
MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization |
26 Nov 2016 |
|
|
AHWP/WG6/F002:2016 |
MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes |
26 Nov 2016 |
|
|
AHWP/WG6/F003:2016 |
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition |
26 Nov 2016 |
|
|
AHWP/WG6/F004:2016 |
Competence and Training Requirements for Auditing Organizations |
26 Nov 2016 |
|
|
AHWP/WG6/F001:2015 |
Distributor Auditing Checklist |
6 Nov 2015 |
|
|
AHWP/WG6/F002:2015 |
Guidance on Regulatory Auditing of Quality Management System of Medical Device Distributions: Auditing Strategies |
6 Nov 2015 |
|
|
AHWP/WG6/F003:2015 |
Regulatory Audit Report Guidance Document |
6 Nov 2015 |
|
Work Group 7
| Document No. | Description | Date | Document |
| GHWP/WG7/F004:2023 | Guidance Document on the Risk-Based Approach to Quality Management System Aspects: ISO13485:2016 | 25 Nov 2023 | Download file: Guidance Document on the Risk-Based Approach to Quality Management System Aspects: ISO13485:2016 |
| GHWP/WG7/F003:2023 | Guidance for Audit Supplier to Medical Device Manufacturers | 30 Nov 2023 | Download file: Guidance for Audit Supplier to Medical Device Manufacturers |
| GHWP/WG7/F002:2023 | A Guide to Understanding Presently Available Audit Duration Determination Systems | 25 Nov 2023 | Download file: A Guide to Understanding Presently Available Audit Duration Determination Systems |
| GHWP/WG7/F001:2023 | A Guide to Understanding Best Practices in Audit Life Cycle Management | 30 Nov 2023 | Download file: A Guide to Understanding Best Practices in Audit Life Cycle Management |
|
AHWP/WG7/F001:2016 |
Quality Management System-Medical Devices Requirements for Distributors, Importers and Authorized Representatives |
26 Nov 2016 |
|
|
AHWP/WG7/F001:2014 |
Guidance on Medical Device Quality Management System - Requirements for Distributors |
21 Nov 2014 |
|
|
AHWP/WG3/F001:2013 |
Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change |
6 Dec 2013 | Download file: Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change |
Work Group 8
| Document No. | Description | Date | Document |
| GHWP/WG8/F001:2023 | Medical Gas System – Essential Principles of Safety and Performance – Standards for Demonstrating Compliance | 16 Feb 2023 | Download file: Medical Gas System – Essential Principles of Safety and Performance – Standards for Demonstrating Compliance.pdf |
| AHWP/WG2-WG8/F002:2014 |
Role of Standards in the Assessment of Medical Devices |
21 Nov 2014 | Download file:Final_GHWP_WG2_WG8_ F002_2014.pdf |
Work Group 9
| Document No. | Description | Date | Document |
| GHWP/WG9/F001:2023 | GHWP UDI Rule | 30 Nov 2023 | Download file: GHWP UDI Rule.pdf |
| AHWP/WG9/F001:2019 | AHWP UDI White Paper | 14 Dec 2019 | Download file: AHWP UDI White Paper |
|
AHWP/WG9/F001:2019 |
Challenges and Recommendations for the Implementation of a Globally Coordinated UDI system | 2 Dec 2019 |
|
Secretariat
| Document No. | Description | Date | Document |
| GHWP/SECRETARIAT/F001:2023 | Amendment 8 to the Global Harmonization Working Party House Rules | 16 Feb 2023 | Download file: Amendment 8 to the Global Harmonization Working Party House Rules.pdf |
| GHWP/SECRETARIAT/F001:2021 | Amendment 8 to the Global Harmonization Working Party (GHWP) & GHWP Technical Committee (GHWPTC) Terms of Reference (TOR) |
1 Dec 2021 | Download file: Amendment 8 to the Global Harmonization Working Party (GHWP) & GHWP Technical Committee (GHWPTC) Terms of Reference (TOR).pdf |
| GHWP/SECRETARIAT/F002:2021 | Amendment 7 to the Global Harmonization Working Party House Rules |
1 Dec 2021 | Download file: Amendment 7 to the Global Harmonization Working Party House Rules.pdf |
|
AHWP/SECRETARIAT/ |
Amendment 6 to the Global Harmonization Working Party House Rules | 22 Nov 2019 | |
|
AHWP/SECRETARIAT/ |
Amendment 7 to the Asian Harmonization Working Party (GHWP) & AHWP Technical Committee (GHWPTC) Terms of Reference (TOR) |
22 Nov 2019 | |
|
AHWP/SECRETARIAT/ |
Amendment 5 to the Asian Harmonization Working Party House Rules | 6 Dec 2017 | |
|
AHWP/SECRETARIAT/ |
Amendment 6 to the Global Harmonization Working Party (GHWP) & GHWP Technical Committee (GHWPTC) Terms of Reference (TOR) |
20 Nov 2017 | |
|
AHWP/SECRETARIAT/ |
GHWP Vision & Mission | 26 Nov 2016 | Download file: FINAL_Document_Vision & Mission_TOR_rev2.pdf |
|
AHWP/SECRETARIAT/ |
Working Group Technical Document Endorsement Mechanism | 26 Nov 2016 |
|
|
AHWP/SECRETARIAT/ |
Working Group Technical Document Endorsement Mechanism |
26 Nov 2016 |
|
|
AHWP/SECRETARIAT/ |
Official Observer |
26 Nov 2016 |
|
| AHWP/Secretariat/ F001:2014 |
Amendment 3 to the Global Harmonization Working Party House Rules |
21 Nov |
|
|
AHWP/SECRETARIAT |
Amendment 2 to the Global Harmonization Working Party House Rules |
6 Dec 2013 |
|
|
AHWP/SECRETARIAT |
Amendment 1 to the GUIDANCE for Member Economy Hosting the Meetings of GHWP or its Technical Committees |
6 Dec 2013 |
|
|
AHWP/SECRETARIAT/ |
Amendment 1 to the Global Harmonization Working Party House Rules |
20 Nov 2012 |
|
|
AHWP/SECRETARIAT/ |
Amendment 2 to the Global Harmonization Working Party (GHWP) & Global Harmonization Working Party Technical Committee (GHWPTC) Terms of Reference |
20 Nov 2012 |
|
|
AHWP/SECRETARIAT/001 |
The Global Harmonization Working Party House Rules |
30 Nov 2010 | Download file: AHWP House Rules (Final) @30Nov2010.pdf |
| AHWP/SECRETARIAT/002 |
Amendment 1 to the Global Harmonization Working Party (GHWP) & Global Harmonization Working Party Technical Committee (GHWPTC) Terms of Reference |
30 Nov 2010 | Download file: AHWP TOR Amendment 1 (Final)@30Nov2010.pdf |
Capacity Building
| Document No. | Description | Date | Document |
| Training Curriculum For Medical Technology Regulatory Authorities |
16 Feb 2023 | Download file: Global Harmonization Working Party Strategic Framework towards 2026.pdf |
|
|
AHWP/AHWP-APACMED-DELOITTE/F001:2019 |
White paper on Competency Framework for Medical Technology Regulators | 22 Nov 2019 |
|
Others
| Document No. | Description | Date | Document |
| GHWP/OB/F001:2023 | Global Harmonization Working Party Strategic Framework towards 2026 | 16 Feb 2023 | Download file: Gobal Harmonization Working Party Strategic Framework towards 2026.pdf |
| AHWP/STG/F001:2015 | Guidance for Medical Device Naming Rule | 6 Nov 2015 |
|
|
AHWP/OB/F001:2013 |
Asian Harmonization Working Party Strategic Framework Towards 2020 - “The Foreseeable Harmonization Horizon” |
6 Dec 2013 | Download file:AHWP DOCUMENT_SFW _FINAL_r.pdf |
| AHWP/STG(LE)/001A |
Asian Harmonization Working Party (AHWP) & Asian Harmonization Working Party Technical Committee (AHWPTC) |
30 Nov 2010 |
|
|
AHWP/STG(LE)/002 |
Memorandum and Articles of Association of AHWP ASL |
7 June 2010 |
|
|
AHWP/TC/LEADERSHIP/001 |
Requirements of Medical Device Nomenclature System for the Asian Harmonization Working Party |
2 March 2010 |
|
|
AHWP/STG(LE)/001 |
Asian Harmonization Working Party (GHWP) & Asian Harmonization Working Party Technical Committee (AHWPTC) Terms of Reference |
6 November 2009 | AHWP_STGLE_001.pdf |