The 2nd African Regulatory Forum on Medical Diagnostics
  1. To review the vision of PAHWP with major stakeholders and industry
  2. To present progress and achievements of PAHWP technical working groups
  3. To identify gaps and challenges
  4. To discuss the way forward
  5. 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

PAHWP Infrastructure

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

Recommendations for review from 1st Forum

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Improving Access to Affordable Diagnostics