African Medical Devices Forum
Forum News
The 3rd African Regulatory Forum on Medical Diagnostics was held on 30th November 2014 in Cape Town. Click here to view their recommendations.
Partner News
Dr Tsehaynesh Messele is due to step down from her position as CEO of the African Society for Laboratory Medicine in April 2015 after 4 successful years. For further details visit the ASLM website.
WORKING GROUP FOR THE REVISION AND UPDATE OF THE WHO GLOBAL MODEL REGULATORY FRAMEWORK FOR MEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTIC MEDICAL DEVICES
WHO is currently updating the WHO Global Model Regulatory Framework for medical devices including IVDS https://apps.who.int/iris/handle/10665/255177 to capture advances
in the medical devices innovations. The objectives of this exercise are to:
1. Revise and update the GMRF as deemed appropriate
2. Keep the focus on the National Regulatory Authorities including the role of the
National Reference Laboratories
3. Expand the contents on specific topics
4. Developing guidance on specific topics
5. Proposal for implementation workshops
WHO has thus established two groups to revise and update the GMRF: a WHO Steering group consisting of WHO/HQ staff members and a Working Group (WG) GMRF consisting of regulatory experts to oversee the revision and update of the GMRF. The revision and update
of the GMRF will be conducted between July 2021 and January 2022 through a number of online meetings and concluded through a final meeting in January 2022. There usually two
sessions in one specified day in a week which happen at two weeks intervals.
you are not participating and wish to be included, kindly write to Ms Agnes Kijo kijoa@who.int
The proceeding of the meeting are reported regularly at the WHO MEdNET platform
https://mednet-communities.net/$root
AMDF Technical committee meeting report and the presentations
- Africa Medical Devices Forum Strategic Plan
- AMDF 2021 Activities Report
- AMDF 2022 Planned Activities
- AMDF Report 2019-2021
- AMDF report to AMRC assembly
- AMDRF TC Meeting report
- Final AMDF Technical Committe Program 24 Nov 2021
- Technical Update EU Medical Device Regulation
- Update on WHO support for medical devices
- WHO MD Nomenclature
Post market Surveillance Workshop
WHO workshop on Post Market Surveillance 15-18 November 2021
Day 1
- Reviewing Medical Devices Incidents
- Introduction and workshop objectives
- Post-market and market surveillance guidance - Link with other WHO tools
- SFDA Implementation of incident reporting
Day 2
- Ghana country Experience FSCA
- Reviewing CAPA for Medical Devices
- Reviewing FSCA.
- SFDA Implementation of Field Safety Notices including corrective and preventive action plans
- South Africa experience on FSCA
Day 3
- Medical device experience - Uganda
- SFDA Experiences on falsified medical devices
- SFDA Experiences In Monitoring The Quality And Safety Of Medical Devices
- SFDA Implementation of Field Safety Notices including corrective and preventive action plans
- Prevent-Detect-Respond-SF-medical products_PBE
Day 4
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Improving Access to Affordable Diagnostics