Final Documents

Submitted by admin on Tue, 12/02/2014 - 16:02

Work Group 1

Document No. Description                    Date Document

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/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/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/WG1/F002:2016

Guidance for Minor Change Reporting 26 Nov 2016

 Download file: Guidance for Minor Change Reporting.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: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/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

 

Work Group 2

Document No. Description                    Date Document

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/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

 Download file: Regulation and treatment of e-IFU and e-Label of Medical Devices-Review of International Practice.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 Medical Devices.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/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
2014

 Download file:Final_AHWP_WG2_
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/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

 

Work Group 3

Document No. Description                    Date Document

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 Documetn on MEdical Device Software - Qualification and Classification

6 Nov 2015  Download file:AHWP-WG3_Guidance document on Medical Device Software_FINAL.pdf

 

Work Group 4

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

 

AHWP Safety Alert Dissemination System (SADS) 26 Nov 2016  Download file: FINAL_AHWP-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:AHWP-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_AHWP_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_AHWP_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: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/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

 

Work Group 5

Document No. Description                    Date Document

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: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

 

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

 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/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

 

Work Group 7

Document No. Description                    Date Document

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/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/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

 

Work Group 8

Document No. Description                    Date Document
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

 

Work Group 9

Document No. Description                    Date Document

AHWP/WG9/F001:2019

Challenges and Recommendations for the Implementation of a Globally Coordinated UDI system 2 Dec 2019

 Download file: Challenges and Recommendations for the Implementation of a Globally Coordinated UDI system.pdf

 

Secretariat

Document No. Description                    Date Document

AHWP/SECRETARIAT/
F002:2019 

Amendment 6 to the Asian Harmonization Working Party House Rules 22 Nov 2019

 Download file:
Amendment 6 to AHWP House Rules.pdf

AHWP/SECRETARIAT/
F001:2019

Amendment 7 to the Asian Harmonization Working Party (AHWP) & AHWP Technical Committee (AHWPTC) Terms of Reference (TOR)

22 Nov 2019

 Download file:
Amendment 7 to AHWP and AHWPTC TOR.pdf

AHWP/SECRETARIAT/
F002:2017

Amendment 5 to the Asian Harmonization Working Party House Rules 6 Dec 2017

 Download file:
Amendment 5 to AHWP 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 AHWP and AHWPTC TOR.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/Secretariat/
F001:2014

Amendment 3 to the Asian Harmonization Working Party House Rules

21 Nov
2014 

 Download file: Final_Secretariat_
F001_2014.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/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
 

 

Capacity Building

Document No. Description                    Date Document

AHWP/AHWP-APACMED-DELOITTE/F001:2019

White paper on Competency Framework for Medical Technology Regulators 22 Nov 2019

 Download file: White paper on Competency Framework for Medical Technology Regulators.pdf

 

Others

Document No. Description                    Date Document
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/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)
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

 

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