African Medical Devices Forum
The 2nd African Regulatory Forum on Medical Diagnostics
- To review the vision of PAHWP with major stakeholders and industry
- To present progress and achievements of PAHWP technical working groups
- To identify gaps and challenges
- To discuss the way forward
- To discuss expansion of the PAHWP
Summary of Recommendations from the 2nd African Regulatory Forum on Medical Diagnostics
The meeting was primarily a Forum for discussion and sharing of ideas, view the meeting's agenda for an overview as well as the Forum Report for a full breakdown of the points discussed and the agreements reached. A pre-forum workshop was held.
Pre-Forum Workshop
Landscape of regulation of IVD: Why harmonize, and why now? Rosanna Peeling
PAHWP history, mission and structure Isaac Kadowa
Harmonization priority topics - Clinical Evidence Sarvashni Moodliar
Harmonization priority topics - Post Marketing Surveillance Agnes Kijo
WHO Pre-qualification Training Programme WHO and Tanzania Food & Drug Authority
Global Medical Device Nomenclature Agency (GMDN) Mark Wasmuth
International Medical Device Regulators Forum (IMDRF) Single Audit Programme Ruth McNerney
Risk Classification: Briefing document
Risk Classification: IVD Classification Rules Rosanna Peeling and Agnes Kijo
Common Registration File and Good Review Practice Elliot Cowan
Avoiding duplication in clinical performance studies Rosanna Peeling/Maurine Murtagh/Ben Cheng
Post market surveillance Patience Dabula
2nd Regulatory Forum
Global Medical Device Nomenclature (GMDN) Mark Wasmuth
IVD Regulatory FRamework Benny Ons
Update on WHO Pre-qualification Program Willy Urassa
Update from Latin America Rosanna Peeling
IMDRF Single Audit Program Ruth McNerney
ISO Standards Benny Ons
Clinical evaluation studies Maurine Murtagh
Expanding PAHWP Tsehaynesh Messele
Post Market Surveillance - next steps Patience Dabula
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Improving Access to Affordable Diagnostics