Resources

African Medical Devices Forum

Resources

A list of resources you may find useful are listed below. Please feel free to use and disseminate them however please If you have a suggestion for other resources that would be useful to PAHWP members please do not hesitate to contact Chris Sanders to recommend them.

New publication:

Regulation of medical diagnostics and medical devices in the East African Community partner states. Rugera et al BMC Health Services Research 2014, 14:524 http://www.biomedcentral.com/1472-6963/14/524

Links to organisations and key documents relevant to harmonization of regulation for medical devices and IVD:

Regulatory Updates

AMDF Guidelines

AMDF is glad to share four guidelines in English and French that have been approved by the African Medicine Harmonization Secretariat. The guidelines are ready to be used to improve available national guidelines (adaption) or used as they are (adoption) by those NRA which do not have such guidelines. Word versions of the guidelines can be obtained by writing to WHO (Ms Agnes Kijo kijoa@who.int). AMDF will be organising a dissemination workshop soon to further support the utilization of the guidelines

March 2022
- Guidelines for Registration of Medical Devices Establishments
- Guidelines for Inspection of Manufacturing Site for Assessment of the QMS Medical Devices
- Lignes directrices relatives à l’enregistrement des établissements
- Lignes directrices relatives à l’importation et à l’ex- portation de dispositifs médicaux
- Lignes directrices relatives aux exigences réglementaires de délivrance d’une autorisation
- Guidelines for Importation and Exportation of Medical Devices
- Guidelines on Regulatory Requirements for issuance of Market Authorisation
- Guidelines for Importation and Exportation of Medical Devices
- Annex 3 MD reporting form v2
- Annex 4 SOP AMDF SF Reporting FR
- Annex 4 guidance document on donations WG4 20200415
- French_Forumulaire de Signalement de Plaintes concernant des dipositifs medicaux
- French Orientations pour l'evaluation des dispositifs medicaux
- AMDF Newsletters
  - AMRH: Q1 & Q2 2021 Newsletter
- Other important resource/link
  - AHWP PLAYBOOK for implementation of medical device regulatory frameworks
  - Glossary of terms used at PAHWP meetings
  - Clinical and Laboratory Standards Institute (CLSI) Harmonized Terminology Database
  - Global Harmonization Task Force GHTF
  - GHTF Archived Documents
  - International Medical Device Regulators Forum IMDRF
  - AHWP Work Group 1a IVD Medical Devices
  - The Latin American Alliance for the Development of In Vitro Diagnostics
  - African Medicines Regulatory Harmonization Programme AMRH
  - Southern African Laboratory Diagnostics Association SALDA
  - International Diagnostics Centre
  - A Model Regulatory Program for Medical Devices published by WHO/PAHO 2009
  - Definition of medical device and IVD medical device published by GHTF 2011
  - Principles of In Vitro Diagnostic (IVD) Medical Devices Classification published by GHTF 2007
  - Essential Principles of Safety and Performance of Medical Devices published by GHFT 2007
  - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices published by GHFT 2011
  - Guidance on Mapping of STED to CSDT published by AHWP Technical Committee Working Group 2012
  - Proposal for a regulation of the European Parliament and of the council on IVD European Union 2012
  - ISO13485 Medical Device Standard Translated Into Plain English Praxiom Research Group Ltd

Improving Access to Affordable Diagnostics

African Medical Devices Forum

Resources

New publication:

Links to organisations and key documents relevant to harmonization of regulation for medical devices and IVD:

March 2022

2021