Search across 69,000+ products, devices, trials, documents, and organizations
| Type | Title & Description | Details | Country | Status |
|---|---|---|---|---|
| Trial |
Clinical Performance Evaluation of a Point-of-Care Device for Hemoglobin Measurement
Device - University of Antananarivo - University of Antananarivo, Medical School
|
Mfr: University of Antananarivo
Applicant: University of Antananarivo, Medical School
Sponsor: University of Antananarivo
Cat: Device
Type: Device
|
●
Madagascar
|
Recruiting |
| Trial |
Evaluation of a New Point-of-Care Device for HIV Viral Load Monitoring
Device - Clinton Health Access Initiative, Unitaid - Clinton Health Access Initiative
|
Mfr: Clinton Health Access Initiative, Unitaid
Applicant: Clinton Health Access Initiative
Sponsor: Clinton Health Access Initiative, Unitaid
Cat: Device
Type: Device
|
— | Active, not recruiting |
| Resource |
IMDRF: Principles of Labelling for Medical Devices & IVDs (Edition 2, 2024)
International Medical Device Regulators Forum standards frequently referenced by African NRAs.
|
Cat: Global Standards & IMDRF
|
— | — |
| 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...
|
Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
|
— | — |
| 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...
|
Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
|
— | — |
| 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...
|
Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
|
— | — |
| 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...
|
Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
|
— | — |
| 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...
|
Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
|
— | — |
| Organization |
Tanzania Medicines and Medical Devices Authority (TMDA)
2
|
Cat: 2
|
— | — |
| Product |
AVIBELA_IUD 52MG (50MICROGRAM/24H) INTRA UTERINE DEVICE
|
Mfr: ODYSSEA PHARMA SA, REV DU TRAVAIL16
|
●
MALAWI
|
APPROVED |
| Product |
AVIBELA® RELEASING INTRAUTERINE DEVICE (52 MG)
|
Mfr: 1. ODYSSEA PHARMA SPRL, RUE DU TRAVAIL, 16, B-4460 GRÂCE-HOLLOGNE, BELGIUM
2. STERIGENICS BELGIUM S.A., ZONING INDUSTRIEL DE PETIT-RECHAIN, AVENUE ANDRÉ ERNST, 21, B-4800 VERVIERS, BELGIUM
|
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BOTSWANA
|
APPROVED |
| Product |
ELOIRA 52MG/IUD INTRA UTERINE DEVICE
|
Mfr: PREGNA INTERNATIONAL LIMITED, 342/3, PLOT # 29, BHARAT INDUSTRIAL ESTATE
|
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MALAWI
|
APPROVED |
| Product |
EMILY 52MG INTRAUTERINE DEVICE
|
Mfr: HLL LIFECARE LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ENOVA COPPER T 380 A INTRA-UTERINE DEVICE
|
Mfr: FAMY CARE LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
MIRENA 25MG IUD DEVICE
|
Mfr: BAYER OY
PANSIONTIE 47 FIN-20210 TURKU FINLAND
|
●
BOTSWANA
|
APPROVED |
| Product |
MIRENA 52MICROGRAM INTRAUTERINE DEVICE
|
Mfr: BAYER OY
|
●
MALAWI
|
APPROVED |
| Product |
PANBIO COVID-19 AG RAPID TEST DEVICE (NASOPHARYNGEAL)
|
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GERMANY
|
APPROVED | |
| Product |
PANBIO™ COVID-19 AG RAPID TEST DEVICE (NASAL)
|
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GERMANY
|
APPROVED | |
| Device |
Test Medical Device
General - Class I
|
Mfr: Test Manufacturer
Cat: Class I
|
●
Kenya
|
PENDING |
| Training |
Drug and cosmetic analyst, medical devices analyst, biomedical engineers, ICT officers (In-person)
NRA
|
●
Tanzania
|
Identified |