DOCUMENTS

Work Group 1

Work Group 2

Work Group 3

Work Group 4

Work Group 5

Work Group 6

Work Group 7

Work Group 8

Work Group 9

Secretariat

Capacity Building

Others

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AHWP House Rules (Final)@30Nov2010.pdf

AHWP STGLE002-AHWP Adm Services Ltd _Final Document_.pdf

AHWP TOR Amendment 1(Final)@30Nov2010.pdf

AHWP_LEADERSHIP_001_2Mar2010_Final.pdf

AHWP_STGLE_001.pdf

AHWP-STG_Guidance for Medical Device Naming Rule_FINAL.pdf

AHWP-STGLE-001A@30Nov2010(Final).pdf

AHWP-WG1_Regulation of Combination Products – a Review of International Practice_FINAL.pdf

AHWP-WG1-CSDT Guidance_FINAL.pdf

AHWP-WG3_Guidance document on Medical Device Software_FINAL.pdf

AHWP-WG4-AE Reporting-FINAL.pdf

AHWP-WG5_Clinical Evaluation_FINAL.pdf

AHWP-WG5_Clinical Evidence for IVD medical devices-Key Definitions and Concepts_FINAL.pdf

AHWP-WG5_Clinical Evidence for IVD medical devices-Scientific Validity Determination_FINAL.pdf

AHWP-WG5_Clinical Evidence for Medical Devices-Key Definitions and Concepts_FINAL.pdf

AHWP-WG6_Auditing Checklist_FINAL.pdf

AHWP-WG6_Guidance on Regulatory Auditing of QMS of MD Distributors – Auditing Strategy_FINAL.pdf

AHWP-WG6_Regulatory Audit Report Guidance Document_FINAL.pdf

Amendent 1 to AHWP House Rules_FINAL_20Nov2012.pdf

Amendment 2 to AHWP&TC TOR_FINAL_20Nov2012.pdf

Final_AHWP_Secretariat_F002_2013.pdf

FINAL_AHWP-WG4-SADS_Draft(20161117).pdf

FINAL_Document_Official Observer_TOR_ver2_20170127.pdf

FINAL_Document_Technical Documents Endorsement Procedures_House Rules_rev2.pdf

FINAL_Document_Technical Documents Endorsement Procedures_TOR_rev2.pdf

FINAL_Document_Vision & Mission_TOR_rev2.pdf

FINAL_imdrf-tech-140918-assessment-decision-process-141013.pdf

Final_Secretariat_F001_2014.pdf

FINAL_WG1_Regulation and treatment of e-IFU and e-Label of Medical Devices – Review of International Practice_2.pdf

FINAL_WG2_Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medi.pdf

FINAL__Labelling for In Vitro Diagnostic Medical Devices.pdf

Final_Guidance_for_Minor_Change_Reporting.pdf

Final_Guidance_Handbook_for_approval_of_patient-matched_MD_using_3D Printers.pdf

Guidance Documents

Quality Management System-Medical Devices Requirements for Distributors, Importers and Authorized Representatives

Submitted by admin on Wed, 02/01/2017 – 12:00

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MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

Submitted by admin on Wed, 02/01/2017 – 11:59

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Competence and Training Requirements for Auditing Organizations

Submitted by admin on Wed, 02/01/2017 – 11:58

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

Submitted by admin on Wed, 02/01/2017 – 11:57

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MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

Submitted by admin on Wed, 02/01/2017 – 11:55

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Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative

Submitted by admin on Wed, 02/01/2017 – 11:53

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AHWP Safety Alert Dissemination System (SADS)

Submitted by admin on Wed, 02/01/2017 – 11:51

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Guidance document on Risk Categorisation of Software as a Medical Device

Submitted by admin on Wed, 02/01/2017 – 11:49

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Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device”

Submitted by admin on Wed, 02/01/2017 – 11:47

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Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices

Submitted by admin on Wed, 02/01/2017 – 11:45

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Guidance Documents

Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices

Submitted by admin on Wed, 02/01/2017 – 11:42

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Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Submitted by admin on Wed, 02/01/2017 – 11:40

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Guidance on Regulatory Practices for Combination Products

Submitted by admin on Wed, 02/01/2017 – 11:37

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Guidance on Medical Device Quality Management System – Requirements for Distributors

Submitted by admin on Tue, 12/02/2014 – 12:52

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Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative

Submitted by admin on Tue, 12/02/2014 – 12:50

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Asian Harmonization Working Party Strategic Framework Towards 2020 – “The Foreseeable Harmonization Horizon”

Submitted by admin on Fri, 05/09/2014 – 10:36

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Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change

Submitted by admin on Fri, 05/09/2014 – 10:28

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(WG3 here is referred to WG7 after the restructuring of work groups.)

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Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative

Submitted by admin on Fri, 05/09/2014 – 10:26

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(WG2 here is referred to WG4 after the restructuring of work groups.)

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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

Submitted by admin on Fri, 05/09/2014 – 10:23

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(WG1a here is referred to WG2 after the restructuring of work groups.)

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Essential Principles of Safety and Performance of IVD Medical Devices

Submitted by admin on Fri, 05/09/2014 – 10:21

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(WG1a here is referred to WG2 after the restructuring of work groups.)

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Guidance Documents

AHWP Regulatory Framework for IVD Medical Devices

Submitted by admin on Fri, 05/09/2014 – 10:19

Please refer to the below attached with more information.

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(WG1a here is referred to WG2 after the restructuring of work groups.)

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Amendment 1 to the GUIDANCE for Member Economy Hosting the Meetings of AHWP or its Technical Committees

Submitted by admin on Fri, 05/09/2014 – 10:14

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GUIDANCE for Member Economy hosting the Annual Meetings of AHWP or its Technical Committees

Submitted by admin on Fri, 12/06/2013 – 16:20

1. The host organization of the Member Economy will normally be the national authority for the regulation of medical devices.

2. The host organization of the Member Economy will work together with its local industry association to promote the event locally. The host organization will be asked to provide a

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Adoption of “Medical Device Adverse Event (AE) Report Form”

Submitted by admin on Fri, 11/23/2012 – 19:37

During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of “Medical Device Adverse Event (AE) Report Form”.

Please refer to the below attached with more information.

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(WG2 is referred to WG4 after the restructuring of work groups.)

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Adoption of “Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions”

Submitted by admin on Fri, 11/23/2012 – 19:35

During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of “Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions”.

Please refer to the below attached with more information.

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Adoption of “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1 – 5)”

Submitted by admin on Fri, 11/23/2012 – 19:29

During the 17th GHWP Meeting in Chinese Taipei, it has been agreed the adaption of “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers (Part 1-5)”.

Please refer to the below attached with more information.

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(WG4 is referred to WG6 after the restructuring of work groups.)

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Adoption of “Quality Management System – Medical Devices – Guidance on corrective action and preventive action and related QMS processes”

Submitted by admin on Wed, 11/02/2011 – 16:36

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Adoption of “The Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers”

Submitted by admin on Wed, 11/02/2011 – 16:35

During the 15th GHWP Meeting in Riyadh, it has been agreed the adaption of “The Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers”.

Please refer to the below attached with more information.

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Final Documents on Safety Alert Dissemination System (SADS) and Survey Post Market Surveillance System

Submitted by admin on Sun, 11/02/2008 – 15:40

The GHWP TC WG02 has finalized two documents on SADS, namely the GHWP/WG2/SADS/001: Framework for GHWP Safety Alert Dissemination System and GHWP/WG2/SADS/002: Safety Alert Dissemination Criteria, Procedures and Form, to be used for disseminating safety alerts amongst GHWP Member Economies.

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Premarket Harmonization: Developing A Common Premarket Submission Dossier

Submitted by admin on Fri, 11/24/2006 – 22:04

To download the document, please click the document link below.

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Pagination

Subscribe to Guidance Documents

Reference Document

Submitted by admin on Thu, 08/09/2012 – 12:25

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Final_Guidance_for_Minor_Change_Reporting24112016.pdf

FINAL_Post market resource center.pdf

Medical Device Software Qualification and Classification White Paper – FINAL DOCUMENT.pdf

Comparison between CSDT and STED_IVDDs_Final.pdf

Role of Standards in the Assessment of Medical Devices_Final.pdf

AHWP REFERENCE DOCUMENT_Mapping of CSDT to STED.pdf

AHWP-WG4-PMS Survey Report 20171208 Final Document.pdf

Forms

Application to Join/Update of Record in GHWP

Submitted by admin on Fri, 07/29/2022 – 06:13

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GHWP New Document Request/ New Work Item Proposal Form

Submitted by admin on Fri, 07/29/2022 – 03:35

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GHWP Form: Application to Join the Global Harmonization Working Party Work Group(GHWP WG)

Submitted by admin on Tue, 01/25/2022 – 09:56

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Application Form for Joining the Safety Alert Dissemination System (SADS)

Submitted by admin on Tue, 09/10/2013 – 12:48

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Document No.	Description	Date	Document
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	Download file: Guidance for Minor Change Reporting.pdf
AHWP/WG2-WG1-WG3/F001:2019	Categorisation of Changes to a Registered Medical Device	3 Dec 2019	Download file: Categorisation of Changes to a Registered Medical Device.pdf
AHWP/WG1-WG2-WG3/F002:2019	Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)	2 Dec 2019	Download file: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU).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	Download file: Regulation and treatment of e-IFU and e-Label of Medical Devices-Review of International Practice.pdf
AHWP/WG1/F001:2016	Guidance on Regulatory Practices for Combination Products	26 Nov 2016	Download file: Guidance on Regulatory Practices for Combination Products.pdf
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	Download file:GHWP-WG1-CSDT Guidance_FINAL.pdf
AHWP/WG1/F002:2015	White Paper on Regulation of Combination Products – A review of International Practice	6 Nov 2015	Download file:GHWP-WG1_Regulation of Combination Products – a Review of International Practice_FINAL.pdf
AHWP/WG2_WG1/F001:2015	Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’	6 Nov 2015	Download file:Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’.pdf
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

Document No.	Description	Date	Document
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	Download file: Categorisation of Changes to a Registered Medical Device.pdf
AHWP/WG1-WG2-WG3/F002:2019	Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)	2 Dec 2019	Download file: Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU).pdf
AHWP/WG3/F001:2016	Guidance document on Risk Categorisation of Software as a Medical Device	26 Nov 2016	Download file: Guidance Document on Risk Categorisation of Software as a Medical Device.pdf
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

Document No.	Description	Date	Document
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	Download file: Post Market Resource Center.pdf
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	Download file:GHWP-WG4-AE Reporting-FINAL.pdf
AHWP/WG4/F001:2014	Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative	21 Nov 2014	Download file:Final_GHWP_WG4_ F001_2014.pdf
AHWP/WG2/F001:2013 (now restructured to WG4)	Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative	6 Dec 2013	Download file:Final_GHWP_WG2_ F001_2013.pdf
AHWP/WG2/F002:2012 (now restructured to WG4)	Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions	20 Nov 2012	Download file:GHWP-WG2-PMS-003_FINAL.pdf
AHWP/WG2/F001:2012 (now restructured to WG4)	Medical Device Adverse Event (AE) Report Form	20 Nov 2012	Download file:GHWP-WG2-PMS-002_FINAL.pdf
AHWP/WG2/SADS/002 (now restructured to WG4)	Safety Alert Dissemination System: Safety Alert Dissemination Criteria, Procedures and Form	23 January 2008	GHWP_WG2_SADS_002.pdf
AHWP/WG2/SADS/001 (now restructured to WG4)	Framework for GHWP Safety Alert Dissemination System (SADS)	23 January 2008	GHWP_WG2_SADS_001.pdf

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	Download file: Clinical Evidence for IVD Medical Devices – Clinical Performance Studies for In Vitro Diagnostic Medical Devices .pdf
AHWP/WG5/F002:2017	Post Market Clinical Follow-Up Studies	6 Dec 2017	Download file: Post Market Clinical Follow-Up Studies.pdf
AHWP/WG5/F001:2017	Clinical Investigation	6 Dec 2017	Download file: Clinical Investigation.pdf
AHWP/WG5/F001:2015	Clinical Evaluation	6 Nov 2015	Download file:GHWP-WG5_Clinical Evaluation_FINAL.pdf
AHWP/WG5/F002:2015	Clinical Evidence for Medical Device – Key Definitions and Concepts	6 Nov 2015	Download file:GHWP-WG5_Clinical Evidence for Medical Devices-Key Definitions and Concepts_FINAL.pdf
AHWP/WG5/F003:2015	Clinical Evidence for IVD Medical Device – Key Definitions and Concepts	6 Nov 2015	Download file:GHWP-WG5_Clinical Evidence for IVD medical devices-Key Definitions and Concepts_FINAL.pdf
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