Background
The Africa Centres for Disease Control and Prevention (Africa CDC) in collaboration with AUDA NEPAD through the Center for Laboratory Diagnostics and systems (CLDS) are working to support the African Medicine Agency (AMA) in the implementation of the continental process of diagnostic regulation. As part of this mechanism, the CLDS has established the Diagnostic Advisory Committee (DAC) and one of the priorities is to support the local manufacturing. To ensure manufacturers understand and comply with regulatory requirements, Africa CDC, in collaboration with the AMRH programme of AUDA NEPAD, are organizing a 5-day workshop to train the local manufacturers on the key components of the continental process such as dossiers review and clinical performance evaluation of diagnostics.
Objective of the Training
- Strengthen the technical capacity of local manufacturers in navigating the continental regulatory landscape.
- Train local manufacturers on the components of dossiers review according to the continental requirements.
- Train local manufacturers on the analytical and clinical performance evaluation process by the DAC.
Target Audience
Manufacturers of in vitro diagnostics (IVDs) in Africa.
Technical Expertise
The training will be conducted by experts from the MDA-Tc, AMDF and the DAC.
Training Scope
The training will cover:
- Overview of Africa’s regulatory landscape: AMA, RECs, and national regulatory authorities.
- Harmonized regulatory frameworks and mutual recognition mechanisms.
- Good Manufacturing Practices (GMP) and ISO 13485.
- Clinical evaluation requirements in Africa (process, protocols for analytical and clinical studies).
- Practical steps for regulatory submission and approval.
Format, Dates, Venue
- Format: in-person workshop.
- Dates: 24 to 28 November 2025.
- Venue: Kigali, Rwanda.
Registration
Interested manufacturers are invited to register by completing the application form available at https://forms.gle/4PnjBV6Qpb9ZHjB38 or by email at Saidh@africacdc.org before 24 October 2025.
Selection Criteria
- Demonstrated interest in accessing or expanding within the African market.
- Commitment to comply with African regulatory frameworks.
- Priority will be given to manufacturers submitting IVDs for priority diseases in Africa.
Costs
- Africa CDC will cover round trip tickets and conference packages for up to 15 local manufacturers.
- Participants are expected to cover their accommodation costs only.
Contact Information
For further inquiries, please contact: Halifa SAID at Saidh@africacdc.org
