Final Documents

Document No. Description                    Date Document
AHWP/WG1/F001:2017 Handbook for Approval of Patient-matched Medical Devices Using 3D Printers 21 Nov 2017    Download file: Handbook for Approval of Patient-matched Medical Devices Using 3D Printers.pdf
AHWP/WG2/F001:2017 Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medical Devices 4 Sep 2017    Download file: Guidance for Additional Considerations to support Conformity Assessment of Companion In vitro Diagnostic Medi.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/SECRETARIAT/
F002:2017
Amendment 5 to the Asian Harmonization Working Party House Rules 6 Dec 2017

  Download file: Amendment 5 to the Asian Harmonization Working Party House Rules.pdf

AHWP/SECRETARIAT/
F001:2017

 

 

Amendment 6 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference (TOR) 20 Nov 2017

  Download file: Amendment 6 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference (TOR).pdf

AHWP/WG1/F002:2016

 

 

Guidance for Minor Change Reporting 26 Nov 2016

  Download file: Guidance for Minor Change Reporting .pdf

AHWP/WG2/F001:2016

 

 

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification 26 Nov 2016   Download file: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification .pdf

AHWP/WG2/F002:2016

 

 

Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices 26 Nov 2016   Download file: Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices.pdf

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   Download file: Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices.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/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/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

 

 

AHWP Safety Alert Dissemination System (SADS) 26 Nov 2016   Download file: FINAL_AHWP-WG4-SADS_Draft(20161117).pdf

AHWP/WG6/F001:2016

 

 

MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization 26 Nov 2016   Download file: FINAL_imdrf-tech-140918-assessment-decision-process-141013.pdf

AHWP/WG6/F002:2016

 

 

MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes 26 Nov 2016   Download file: FINAL_imdrf-proc-140918-decision-related-processes.pdf

AHWP/WG6/F003:2016

 

 

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition 26 Nov 2016   Download file: FINAL_imdrf-tech-131209-auditing-requirements-140901.pdf

AHWP/WG6/F004:2016

 

 

Competence and Training Requirements for Auditing Organizations 26 Nov 2016   Download file: FINAL_imdrf-tech-131209-competence-and-training-requirements-140901.pdf

AHWP/WG7/F001:2016

 

 

Quality Management System-Medical Devices Requirements for Distributors, Importers and Authorized Representatives 26 Nov 2016   Download file: AHWP WG7 F001 2014 rev ISO 13485 2016  final (1)_R2.pdf

AHWP/SECRETARIAT/

F001:2016

 

 

AHWP Vision & Mission 26 Nov 2016   Download file: FINAL_Document_Vision & Mission_TOR_rev2.pdf

AHWP/SECRETARIAT/

F002:2016

 

 

Working Group Technical Document Endorsement Mechanism 26 Nov 2016   Download file:FINAL_Document_Technical Documents Endorsement Procedures_TOR_rev2.pdf

AHWP/SECRETARIAT/

F003:2016

 

 

Working Group Technical Document Endorsement Mechanism 26 Nov 2016   Download file:FINAL_Document_Technical Documents Endorsement Procedures_House Rules_rev2.pdf

AHWP/SECRETARIAT/

F004:2016

Official Observer 26 Nov 2016   Download file:FINAL_Document_Official Observer_TOR_ver2_20170127.pdf
AHWP/WG1/F001:2015 Guidance for Preparation of a Common Submission Dossier Template Dossier for Genera Medical Device 6 Nov 2015   Download file:AHWP-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:AHWP-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  
AHWP/WG3/F001:2015 Guidance Documetn on MEdical Device Software - Qualification and Classification 6 Nov 2015   Download file:AHWP-WG3_Guidance document on Medical Device Software_FINAL.pdf
AHWP/WG4/F001:2015 Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representatives 6 Nov 2015    Download file:AHWP-WG4-AE Reporting-FINAL.pdf
AHWP/WG5/F001:2015 Clinical Evaluation 6 Nov 2015    Download file:AHWP-WG5_Clinical Evaluation_FINAL.pdf
AHWP/WG5/F002:2015 Clinical Evidence for Medical Device - Key Definitions and Concepts 6 Nov 2015    Download file:AHWP-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:AHWP-WG5_Clinical Evidence for IVD medical devices-Key Definitions and Concepts_FINAL.pdf
AHWP/WG5/F004:2015 Clinical Evidence for IVD - Scientifnic Validity Determination and Performance Evaluation 6 Nov 2015    Download file:AHWP-WG5_Clinical Evidence for IVD medical devices-Scientific Validity Determination_FINAL.pdf
AHWP/WG6/F001:2015 Distributor Auditing Checklist 6 Nov 2015    Download file:AHWP-WG6_Auditing Checklist_FINAL.pdf
AHWP/WG6/F002:2015 Guidance onRegulatory Auditing of Quality Management System of Medical Device Distributions: Auditing Strategies 6 Nov 2015    Download file:AHWP-WG6_Guidance on Regulatory Auditing of QMS of MD Distributors - Auditing Strategy_FINAL.pdf
AHWP/WG6/F003:2015 Regulatory Audit Report Guidance Document 6 Nov 2015    Download file:AHWP-WG6_Regulatory Audit Report Guidance Document_FINAL.pdf
AHWP/STG/F001:2015 Guidance for Medical Device Naming Rule 6 Nov 2015    Download file:AHWP-STG_Guidance for Medical Device Naming Rule_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_AHWP_WG4_
F001_2014.pdf

AHWP/WG2/F001:2014 Comparison between CSDT and STED IVDDs 21 Nov
2014
  Download file:Final_AHWP_WG2_
F001_2014.pdf
AHWP/WG7/F001:2014 Guidance on Medical Device Quality Management System - Requirements for Distributors 21 Nov 2014    Download file:Final_AHWP_WG7_
F001_2014.pdf
AHWP/WG1/F001:2014 White Paper on Medical Device -Software Qualification and Classification White Paper 21 Nov 2014    Download file:Final_AHWP_WG1_F001_
2014.pdf
AHWP/WG2-WG8/F002:2014 Role of Standards in the Assessment of Medical Devices 21 Nov 2014    Download file:Final_AHWP_WG2_WG8_
F002_2014.pdf
AHWP/Secretariat/
F001:2014
Amendment 3 to the Asian Harmonization Working Party House Rules 21 Nov
2014 
  Download file:Final_Secretariat_F001_
2014.pdf

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/WG3/F001:2013
(now restructured to WG7)
Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Ex-change 6 Dec 2013   Download file:Final_AHWP_WG3_
F001_2013.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_AHWP_WG2_
F001_2013.pdf
AHWP/WG1a/F004:2013
(now restructured to WG2)
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   Download file:Final_AHWP_WG1a_
F004_2013.pdf
 AHWP/WG1a/F002:2013
(now restructured to WG2)
Essential Principles of Safety and Performance of IVD Medical Devices 6 Dec 2013   Download file:Final_AHWP_WG1a
_F002_2013.pdf
AHWP/WG1a/F001:2013
(now restructured to WG2)
AHWP Regulatory Framework for IVD Medical Devices 6 Dec 2013   Download file:Final_AHWP_WG1a_
F001_2013.pdf
AHWP/SECRETARIAT
/F002:2013
Amendment 2 to the Asian Harmonization Working Party House Rules 6 Dec 2013   Download file:Final_AHWP_Secretariat_
F002_2013.pdf

AHWP/SECRETARIAT
/F001:2013

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

6 Dec 2013   Download file:Final_AHWP_Secretariat
_F001_2013.pdf

AHWP/SECRETARIAT

/F002:2012

Amendment 1 to the Asian Harmonization Working Party House Rules 20 Nov 2012   Download file:Amendent 1 to AHWP House Rules_FINAL_20Nov2012.pdf

AHWP/SECRETARIAT

/F001:2012

Amendment 2 to the Asian Harmonization Working Party (AHWP) &
Asian Harmonization Working Party Technical Committee
(AHWPTC) Terms of Reference
20 Nov 2012   Download file:Amendment 2 to AHWP&TC TOR_FINAL_20Nov2012.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:AHWP-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:AHWP-WG2-PMS-002_FINAL.pdf
AHWP/SECRETARIAT/001 The Asian Harmonization Working Party House Rules 30 Nov 2010  Download file:AHWP
House Rules (Final)
@30Nov2010.pdf
AHWP/SECRETARIAT/002 Amendment 1 to the Asian Harmonization Working Party (AHWP) &
Asian Harmonization Working Party Technical Committee
(AHWPTC) Terms of Reference
30 Nov 2010   Download file:AHWP
TOR Amendment 1
(Final)@30Nov2010
.pdf

 
AHWP/STG(LE)/001A Asian Harmonization Working Party (AHWP) & Asian
Harmonization Working Party Technical Committee (AHWPTC)
Terms of Reference (Amendment 1)
30 Nov 2010   Download file:AHWP-STGLE-1A@30Nov2010(Final).pdf
AHWP/STG(LE)/002 AHWP STGLE002-AHWP Adm Services Ltd (Proposed Final Document) 7 June 2010  Download file:AHWP STGLE002-AHWP Adm
Services Ltd _Final
Document_.pdf
AHWP/TC/LEADERSHIP/001 Requirements of Medical Device Nomenclature System for the Asian Harmonization Working Party 2 March 2010  Download file:AHWP_LEADERSHIP_
001_2Mar2010_Final.pdf
AHWP/STG(LE)/001 Asian Harmonization Working Party (AHWP) & Asian
Harmonization Working Party Technical Committee (AHWPTC)
Terms of Reference
6 November 2009  AHWP_STGLE_001.pdf

AHWP/WG2/SADS/002
(now restructured to WG4)

Safety Alert Dissemination System: Safety Alert Dissemination
Criteria, Procedures and Form
23 January 2008  AHWP_WG2_SADS_002.pdf
AHWP/WG2/SADS/001
(now restructured to WG4)
Framework for AHWP Safety Alert Dissemination System (SADS) 23 January 2008  AHWP_WG2_SADS_001.pdf