Search across 69,000+ products, devices, trials, documents, and organizations
| Type | Title & Description | Details | Country | Status |
|---|---|---|---|---|
| Resource |
IMDRF: Principles of Labelling for Medical Devices & IVDs (Edition 2, 2024)
International Medical Device Regulators Forum standards frequently referenced by African NRAs.
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Cat: Global Standards & IMDRF
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| Resource |
Africa Medical Devices Forum (AMDF)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
IMDRF–Africa Medical Devices Report
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
AMDF Guideline: Registration of Medical Device Establishments (English draft)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
AMDF Guideline: Importation & Exportation of Medical Devices (English draft)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
AMDF: Specific Considerations for Regulating MNCH Medical Devices (Market Authorisation)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
TMDA Public Notice – Expression of Interest: Evaluators of Medicinal Products and Medical Devices (2024)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
Medical Device Registration Guidelines (PDF, 2016)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Medical Devices Regulations (PDF, 2015)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Guidelines: Import/Export of Medical Devices incl. IVDs (PDF, 2020)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Compendium: Devices/Diagnostics/Lab Equipment (PDF, June 2024)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
TMDA: Medical Devices marketing authorisation procedures
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
AMDF Technical Committee
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
WHO Africa – AMDF COVID-19 Report
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
AMDF Guideline: Inspection of Manufacturing Sites (French draft)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
AMDF Guideline: Enregistrement des établissements (French draft)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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| Resource |
AMDF Guideline: Importation/Exportation de dispositifs médicaux (French draft)
Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and refe...
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Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
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