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
|
โ
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
|
โ | 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
|
โ | โ |
| 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)
|
โ | โ |
| Resource |
IMDRFโAfrica 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)
|
โ | โ |
| 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)
|
โ | โ |
| 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)
|
โ | โ |
| 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)
|
โ | โ |
| Organization |
Tanzania Medicines and Medical Devices Authority (TMDA)
2
|
Cat: 2
|
โ | โ |
| Product |
AVIBELA_IUD 52MG (50MICROGRAM/24H) INTRA UTERINE DEVICE
|
Mfr: ODYSSEA PHARMA SA, REV DU TRAVAIL16
|
โ
MALAWI
|
APPROVED |
| Product |
AVIBELAยฎ RELEASING INTRAUTERINE DEVICE (52 MG)
|
Mfr: 1. ODYSSEA PHARMA SPRL, RUE DU TRAVAIL, 16, B-4460 GRรCE-HOLLOGNE, BELGIUM
2. STERIGENICS BELGIUM S.A., ZONING INDUSTRIEL DE PETIT-RECHAIN, AVENUE ANDRร ERNST, 21, B-4800 VERVIERS, BELGIUM
|
โ
BOTSWANA
|
APPROVED |
| Product |
ELOIRA 52MG/IUD INTRA UTERINE DEVICE
|
Mfr: PREGNA INTERNATIONAL LIMITED, 342/3, PLOT # 29, BHARAT INDUSTRIAL ESTATE
|
โ
MALAWI
|
APPROVED |
| Product |
EMILY 52MG INTRAUTERINE DEVICE
|
Mfr: HLL LIFECARE LIMITED
|
โ
MALAWI
|
APPROVED |
| Product |
ENOVA COPPER T 380 A INTRA-UTERINE DEVICE
|
Mfr: FAMY CARE LIMITED
|
โ
MALAWI
|
APPROVED |
| Product |
MIRENA 25MG IUD DEVICE
|
Mfr: BAYER OY
PANSIONTIE 47 FIN-20210 TURKU FINLAND
|
โ
BOTSWANA
|
APPROVED |
| Product |
MIRENA 52MICROGRAM INTRAUTERINE DEVICE
|
Mfr: BAYER OY
|
โ
MALAWI
|
APPROVED |
| Product |
PANBIO COVID-19 AG RAPID TEST DEVICE (NASOPHARYNGEAL)
|
โ
GERMANY
|
APPROVED | |
| Product |
PANBIOโข COVID-19 AG RAPID TEST DEVICE (NASAL)
|
โ
GERMANY
|
APPROVED | |
| Device |
Test Medical Device
General - Class I
|
Mfr: Test Manufacturer
Cat: Class I
|
โ
Kenya
|
PENDING |
| Training |
Drug and cosmetic analyst, medical devices analyst, biomedical engineers, ICT officers (In-person)
NRA
|
โ
Tanzania
|
Identified | |
| Training |
Drug and cosmetic analyst, medical devices analyst, biomedical engineers, ICT officers (In-person)
NRA
|
โ
Tanzania
|
Identified | |
| Training |
QMS staff and Medical Devices team leads (In-person)
NRA
|
โ
Uganda
|
Identified | |
| Training |
Manager,Device officers and Technicians,Laboratory assisstant (Online)
NRA
|
โ
Uganda
|
Identified | |
| Training |
Manager,Device Officers and Technicians (Hybrid)
NRA
|
โ
Uganda
|
Identified | |
| Training |
Analysts in Vaccines, Biologics & Medical Devices Laboratory services (In-person)
NRA
|
โ
Nigeria
|
Identified | |
| Training |
Analysts in Vaccines, Biologics & Medical Devices Laboratory services (In-person)
NRA
|
โ
Nigeria
|
Identified | |
| Training |
Staff of Vaccines, Biologics & Medical Devices Registration & Regulatory Affairs Directorate, Vaccines, Biologics & Medical Devices Laboratory Services Directorate and Drug Evaluation & Research Directorate (for clinical data evaluation) (In-person)
NRA
|
โ
Nigeria
|
Identified | |
| Training |
Staff of Vaccines, Biologics & Medical Devices Registration & Regulatory Affairs Directorate, Vaccines, Biologics & Medical Devices Laboratory Services Directorate and Drug Evaluation & Research Directorate (for clinical data evaluation) (In-person)
NRA
|
โ
Nigeria
|
Identified | |
| Training |
Medical device โ standards and link to product evaluation (Online)
NRA
|
โ
South Africa
|
Identified | |
| Training |
Inspection of medical devices, cosmetics or therapeutic use, hygiene products related establishments (Hybrid)
NRA
|
โ
Madagascar
|
Planning | |
| Training |
Assessment of medical devices (In-person)
NRA
|
โ
Eswatini
|
Planning | |
| Training |
Clinical trial applications for medical devices (In-person)
NRA
|
โ
Eswatini
|
Planning | |
| Training |
Pediatric drug and medical devices quality, safety and efficacy (In-person)
NRA
|
โ
Uganda
|
Planning | |
| Training |
Medical Devices Method development Verification or Validation (Online)
NRA
|
โ
Uganda
|
Planning | |
| Training |
Material Characerisation for medical Devices (Hybrid)
NRA
|
โ
Uganda
|
Planning | |
| Training |
Biocompatibility tetsting for medical devices (Hybrid)
NRA
|
โ
Uganda
|
Planning | |
| Training |
Manager training: Medical devices (Online)
NRA
|
โ
South Africa
|
Planning | |
| Training |
Medical device Regulation by different countries (Hybrid)
NRA
|
โ
South Africa
|
Planning | |
| Training |
Medical device ๏ฟฝ standards and link to product evaluation (Online)
NRA
|
โ
South Africa
|
Planning | |
| Training |
Sampling of pharmaceutical products and medical devices (Online)
NRA
|
โ
Algeria
|
Planning | |
| Training |
Manager,Device Officers and Technicians , Laboratory assisstant (Online)
NRA
|
โ
Uganda
|
Identified | |
| Resource |
TMDA Public Notice โ 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).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
โ | โ |
| Resource |
Medical Device Registration Guidelines (PDF, 2016)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) โ Country Guidance & Publications
|
โ | โ |
| Resource |
Medical Devices Regulations (PDF, 2015)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) โ Country Guidance & Publications
|
โ | โ |
| Resource |
Guidelines: Import/Export of Medical Devices incl. IVDs (PDF, 2020)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) โ Country Guidance & Publications
|
โ | โ |
| Resource |
Compendium: Devices/Diagnostics/Lab Equipment (PDF, June 2024)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) โ Country Guidance & Publications
|
โ | โ |
| Resource |
TMDA: Medical Devices marketing authorisation procedures
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) โ Country Guidance & Publications
|
โ | โ |
| Trial |
Effectiveness of a New Long-Lasting Insecticidal Net (LLIN) in Preventing Malaria in Pregnant Women in South Sudan
Device - Bill & Melinda Gates Foundation - Malaria Consortium
|
Mfr: Bill & Melinda Gates Foundation
Applicant: Malaria Consortium
Sponsor: Bill & Melinda Gates Foundation
Cat: Device
Type: Device
|
โ | Active |
| Trial |
Evaluation of a New Insecticide-Treated Net for Malaria Prevention
Device - Bill & Melinda Gates Foundation - National Malaria Control Program - Madagascar
|
Mfr: Bill & Melinda Gates Foundation
Applicant: National Malaria Control Program - Madagascar
Sponsor: Bill & Melinda Gates Foundation
Cat: Device
Type: Device
|
โ
Madagascar
|
Active |
| Pharmacovigilance |
Test
Drug - HealthCare Devices Inc - Report
|
Mfr: HealthCare Devices Inc
Cat: Drug
Type: Drug
Source: Report
|
โ | APPROVED |
| Device |
Boston Scientific Cardiac Pacemaker Accolade MRI
Implantable Devices - Class D - Cardiac Pacemaker
|
Mfr: Boston Scientific
Cat: Class D
|
โ
Botswana
|
PENDING |
| Device |
BreatheEasy Nebulizer
Respiratory devices - Class B - Nebulizer, compressed gas-powered
|
Mfr: Respiratory Care Kenya
Cat: Class B
|
โ
Kenya
|
PENDING |
| Device |
CardioCheck Plus
Cardiovascular Diagnostic Devices - Class C - Blood glucose monitoring system, portable
|
Mfr: MedTech Innovations SA
Cat: Class C
|
โ
South Africa
|
PENDING |
| Device |
DermaScan Imaging System
Dermatology Imaging Devices - Class B - Skin imaging system
|
Mfr: Dermatology Imaging Inc
Cat: Class B
|
โ
Ghana
|
PENDING |
| Device |
Disposable Finger Splint
Immobilization Devices - Class A - Finger splint, disposable
|
Mfr: OrthoFlex Supplies
Cat: Class A
|
โ
South Africa
|
PENDING |
| Device |
Disposable Urine Bag
Urinary Collection Devices - Class A - Urine collection bag
|
Mfr: UroCare Medical
Cat: Class A
|
โ
Algeria
|
PENDING |
| Device |
FlexiCast Wrist Support
Orthopedic devices - Class A - Wrist orthosis, prefabricated
|
Mfr: OrthoPro Kenya
Cat: Class A
|
โ
Kenya
|
PENDING |
| Device |
GlucoCheck Monitor
In Vitro Diagnostic Devices - Class B - Blood Glucose Monitoring System
|
Mfr: Diabetes Care Solutions
Cat: Class B
|
โ
Tanzania
|
PENDING |
| Device |
HemoControl System
Blood Collection Devices - Class C - Blood collection set
|
Mfr: HaemaTech Ltd
Cat: Class C
|
โ
South Africa
|
PENDING |
| Device |
MamaCare Ultrasound
Obstetric/Gynecologic Devices - Class B - Obstetric Ultrasound Scanner
|
Mfr: Obstetric Imaging Solutions
Cat: Class B
|
โ
Rwanda
|
PENDING |
| Device |
Medical Ice Pack
Therapy Devices - Class A - Ice pack, medical
|
Mfr: ColdTherapy Medical
Cat: Class A
|
โ
Algeria
|
PENDING |
| Device |
NeuroMonitor 5000
Neurological Monitoring Devices - Class C - Electroencephalograph
|
Mfr: NeuroDynamics Inc
Cat: Class C
|
โ
Nigeria
|
PENDING |
| Device |
SafeBirth Fetal Doppler
Obstetric and gynecologic devices - Class A - Fetal ultrasonic monitor, handheld
|
Mfr: Maternal Health Devices Ltd
Cat: Class A
|
โ
Kenya
|
PENDING |
| Device |
Stryker Trauma Orthopedic Implant System
Implantable Devices - Class D - Orthopedic Bone Plate
|
Mfr: Stryker Corporation
Cat: Class D
|
โ
Zimbabwe
|
PENDING |
| Device |
Suction Catheter
Chest Drainage Device - Class B - 1
|
Mfr: GUANGDONG MEDICINES AND HEALTH PRODUCTS IMP. & EXP. CO., LTD.
Cat: Class B
|
โ
Ethiopia
|
PENDING |
| Device |
SuperOrtho Ankle Support
OneTouch Delica Plus Lancing device - Class B - 1
|
Mfr: RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD
Cat: Class B
|
โ
Senegal
|
PENDING |
| Device |
SuperOrtho Knee Support
OneTouch Delica Plus Lancing device - Class D - 1
|
Mfr: LINEAR CHEMICALS S.L.U
Cat: Class D
|
โ
Ghana
|
PENDING |
| Device |
SuperOrtho Magnetic Back Brace/ Posture Brace
OneTouch Delica Plus Lancing device - Class D - 1
|
Mfr: SENSA CORE MEDICAL INSTRUMENTATION PVT. LTD
Cat: Class D
|
โ
Namibia
|
PENDING |
| Device |
SureTest HIV Rapid Test Kit
In vitro diagnostic devices - Class B - Test kit, human immunodeficiency virus (HIV)
|
Mfr: Diagnostic Solutions Inc.
Cat: Class B
|
โ
Malawi
|
PENDING |
| Device |
Surgical Stapler AutoClose
Surgical Staplers - Class B - Surgical Stapling Device
|
Mfr: Surgical Innovations Inc
Cat: Class B
|
โ
Nigeria
|
PENDING |
| Device |
Ventura Advanced
Respiratory Therapy Devices - Class C - Ventilator, intensive care
|
Mfr: RespiraCare Inc
Cat: Class C
|
โ
South Africa
|
PENDING |
| Trial |
A Randomized Controlled Trial of a New Hemostatic Dressing for Trauma Wounds in Conflict-Affected Settings in South Sudan
Device - U.S. Army Medical Research and Development Command - Mรฉdecins Sans Frontiรจres (MSF)
|
Mfr: U.S. Army Medical Research and Development Command
Applicant: Mรฉdecins Sans Frontiรจres (MSF)
Sponsor: U.S. Army Medical Research and Development Command
Cat: Device
Type: Device
|
โ | Not yet recruiting |
| Trial |
A Randomized Controlled Trial of a New Wound Dressing for Conflict-Related Injuries
Device - Mรฉdecins Sans Frontiรจres Operational Center Brussels - Mรฉdecins Sans Frontiรจres (MSF) Somalia
|
Mfr: Mรฉdecins Sans Frontiรจres Operational Center Brussels
Applicant: Mรฉdecins Sans Frontiรจres (MSF) Somalia
Sponsor: Mรฉdecins Sans Frontiรจres Operational Center Brussels
Cat: Device
Type: Device
|
โ
Somalia
|
Recruiting |
| Trial |
Clinical Evaluation of a Point-of-Care Test for Hepatitis B Surface Antigen (HBsAg) in Antenatal Clinics in South Sudan
Device - Clinton Health Access Initiative (CHAI) - South Sudan AIDS Commission
|
Mfr: Clinton Health Access Initiative (CHAI)
Applicant: South Sudan AIDS Commission
Sponsor: Clinton Health Access Initiative (CHAI)
Cat: Device
Type: Device
|
โ | Recruiting |
| Trial |
Community-Based Randomized Trial of a New Water Purification Solution for the Prevention of Diarrheal Diseases
Device - Centers for Disease Control and Prevention (CDC) - Oxfam
|
Mfr: Centers for Disease Control and Prevention (CDC)
Applicant: Oxfam
Sponsor: Centers for Disease Control and Prevention (CDC)
Cat: Device
Type: Device
|
โ | Recruiting |
| Trial |
Evaluation of a New Rapid Diagnostic Test for Tuberculosis in Bujumbura
Device - University of Burundi, EDCTP - University of Burundi
|
Mfr: University of Burundi, EDCTP
Applicant: University of Burundi
Sponsor: University of Burundi, EDCTP
Cat: Device
Type: Device
|
โ | Active, not recruiting |
| Trial |
Evaluation of a Rapid Diagnostic Test for Tuberculosis in Primary Health Care Centers
Device - International Union Against Tuberculosis and Lung Disease, Somaliland Ministry of Health - Hargeisa Health Research Center
|
Mfr: International Union Against Tuberculosis and Lung Disease, Somaliland Ministry of Health
Applicant: Hargeisa Health Research Center
Sponsor: International Union Against Tuberculosis and Lung Disease, Somaliland Ministry of Health
Cat: Device
Type: Device
|
โ
Somalia
|
Recruiting |
| Trial |
Evaluation of a Rapid Diagnostic Test for Visceral Leishmaniasis in Primary Health Care Settings in South Sudan
Device - Foundation for Innovative New Diagnostics (FIND) - World Health Organization
|
Mfr: Foundation for Innovative New Diagnostics (FIND)
Applicant: World Health Organization
Sponsor: Foundation for Innovative New Diagnostics (FIND)
Cat: Device
Type: Device
|
โ | Active, not recruiting |
| Trial |
Point-of-Care Viral Load Testing to Improve HIV Treatment Outcomes in Malawi (POC-MW)
Device - Elizabeth Glaser Pediatric AIDS Foundation - Baylor College of Medicine Children's Foundation Malawi
|
Mfr: Elizabeth Glaser Pediatric AIDS Foundation
Applicant: Baylor College of Medicine Children's Foundation Malawi
Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Cat: Device
Type: Device
|
โ | Recruiting |
| Pharmacovigilance |
Implantable Defibrillator Inappropriate Shocks
Device - HeartGuard Technologies - Consumer
|
Mfr: HeartGuard Technologies
Cat: Device
Type: Device
Source: Consumer
|
โ
South Africa
|
PENDING |
| Pharmacovigilance |
Faulty Surgical Stapler Causing Postoperative Leak
Device - SurgiTech International - Healthcare Professional
|
Mfr: SurgiTech International
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Nigeria
|
PENDING |
| Pharmacovigilance |
Ventilator Circuit Contamination
Device - Philips Respironics - Healthcare Professional
|
Mfr: Philips Respironics
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Egypt
|
PENDING |
| Pharmacovigilance |
Prosthetic Heart Valve Thrombosis
Device - CardioVascular Implants Ltd - Healthcare Professional
|
Mfr: CardioVascular Implants Ltd
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Nigeria
|
PENDING |
| Pharmacovigilance |
Implantable Defibrillator Battery Premature Depletion
Device - Boston Scientific - Medical Device Safety Officer
|
Mfr: Boston Scientific
Cat: Device
Type: Device
Source: Medical Device Safety Officer
|
โ
Kenya
|
PENDING |
| Pharmacovigilance |
Hip Prosthesis Early Loosening
Device - Zimmer Biomet - Healthcare Professional
|
Mfr: Zimmer Biomet
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Kenya
|
PENDING |
| Pharmacovigilance |
Insulin Pump Failure Resulting in Severe Hyperglycemia
Device - DiaCare Solutions - Consumer
|
Mfr: DiaCare Solutions
Cat: Device
Type: Device
Source: Consumer
|
โ
Ghana
|
PENDING |
| Pharmacovigilance |
Insulin Pump Software Failure
Device - Insulet Corporation - Consumer
|
Mfr: Insulet Corporation
Cat: Device
Type: Device
Source: Consumer
|
โ
South Africa
|
PENDING |
| Pharmacovigilance |
Allergic Contact Dermatitis from Transdermal Patch
Device - Mylan - Dermatologist
|
Mfr: Mylan
Cat: Device
Type: Device
Source: Dermatologist
|
โ
Ghana
|
PENDING |
| Pharmacovigilance |
Cardiac Pacemaker Malfunction
Device - Medtronic - Healthcare Professional
|
Mfr: Medtronic
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Egypt
|
PENDING |
| Pharmacovigilance |
Cardiac Pacemaker Malfunction Leading to Syncope
Device - CardioTech Global - Consumer
|
Mfr: CardioTech Global
Cat: Device
Type: Device
Source: Consumer
|
โ
South Africa
|
PENDING |
| Pharmacovigilance |
Malfunction of infusion pump leading to overdose
Device - Becton Dickinson - Hospital
|
Mfr: Becton Dickinson
Cat: Device
Type: Device
Source: Hospital
|
โ
South Africa
|
PENDING |
| Pharmacovigilance |
Catheter fracture during removal procedure
Device - BD - Healthcare Professional
|
Mfr: BD
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Ghana
|
PENDING |
| Pharmacovigilance |
Pacemaker lead dislodgement
Device - Abbott - Healthcare Professional
|
Mfr: Abbott
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Kenya
|
PENDING |
| Pharmacovigilance |
Surgical mesh erosion through vaginal wall
Device - Johnson & Johnson - Healthcare Professional
|
Mfr: Johnson & Johnson
Cat: Device
Type: Device
Source: Healthcare Professional
|
โ
Kenya
|
PENDING |
| Resource |
AMDF Technical Committee
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)
|
โ | โ |
| Resource |
WHO Africa โ AMDF COVID-19 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)
|
โ | โ |
| 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...
|
Cat: Medical Devices & Diagnostics Regulation (AMDF and related)
|
โ | โ |
| Resource |
AMDF Guideline: Enregistrement des รฉtablissements (French 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)
|
โ | โ |
| Resource |
AMDF Guideline: Importation/Exportation de dispositifs mรฉdicaux (French 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)
|
โ | โ |
| Product |
BALFEN 400MG TABLETS BP
|
Mfr: 1.BAL PHARMA LIMITED,
21&22 BOMMASANDRA INDUSTRIAL AREA,
BANGALORE, INDIA 560099
2.MDB PHARMA (PTY) LTD, PLOT 1104, SEKOLWANA INDUSTRIAL, TLOKWENG, P.O BOX 1708, MOLEPOLOLE (PRIMARY PACKAGING SITE)
|
โ
BOTSWANA
|
APPROVED |
| Product |
EXAPINE
|
Mfr: WADI EL NEEL BENTA FOR PHARMACEUTICALS AND MEDICAL DEVICES (WNB)
|
โ
ZIMBABWE
|
APPROVED |
| Product |
MDB-CLO C 1% W/W USP CREAM
|
Mfr: AKRITI PHARMACEUTICALS PVT LTD., PLOT NO. D-10, D-11, M.I.D.C. INDUSTRIAL ESTATE, JEJURI-NIRA ROAD, TAL PURANDHAR (SASWAD), DIST PUNE 412303, MAHARASHTRA, INDIA
|
โ
BOTSWANA
|
APPROVED |
| Product |
MDB-CLOT 100 VAGINAL UNCOATED TABLETS USP 100MG
|
Mfr: AKRITI PHARMACEUTICALS PVT LTD.
PLOT NO. D-10, D-11, M.I.D.C. INDUSTRIAL ESTATE, JEJURI-NIRA ROAD, TAL PURANDHAR (SASWAD), DIST PUNE 412303, MAHARASHTRA, INDIA
|
โ
BOTSWANA
|
APPROVED |
| Product |
MDB-FOL 5 MG UNCOATED TABLETS
|
Mfr: 1.AKRITI PHARMACEUTICALS PVT. LTD.
D -10, AND D-11, M.I.D.C. JEJURI-NIRA ROAD, JEJURI, TALUKA PURANDHAR (SASWAD), DIST. PUNE 412303, MAHARASHTRA STATE, INDIA
2.MDB PHARMA
PLOT 1104, SEKOLWANA INDUSTRIAL, TLOKWENG, BOTSWANA (SECONDARY PACKAGING SITE)
|
โ
BOTSWANA
|
APPROVED |
| Product |
MDB-FOL 5 MG UNCOATED TABLETS
|
Mfr: 1.AKRITI PHARMACEUTICALS PVT. LTD.
D -10, AND D-11, M.I.D.C. JEJURI-NIRA ROAD, JEJURI, TALUKA PURANDHAR (SASWAD), DIST. PUNE 412303, MAHARASHTRA STATE, INDIA
2.MDB PHARMA
PLOT 1104, SEKOLWANA INDUSTRIAL, TLOKWENG, BOTSWANA (SECONDARY PACKAGING SITE)
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โ
BOTSWANA
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APPROVED |
| Product |
NOVA-T 380
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โ | APPROVED | |
| Product |
TRUST STRAWBERRY STUDDED CONDOMS
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Mfr: TTK HEALTHCARE LIMITED โ PROTECTIVE DEVICES DIVISION
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SOUTH AFRICA
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APPROVED |
| Product |
WOMASTIN
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Mfr: KHANDELWAL LABORATORIES PVT LIMITED
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โ
UGANDA
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APPROVED |
| Product |
WOMASTIN
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Mfr: KHANDELWAL LABORATORIES PVT LIMITED
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โ
UGANDA
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APPROVED |
| Device |
Blood Pressure Monitor
Monitoring Equipment - Class IIa - Sphygmomanometer
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Mfr: HealthCare Devices Inc
Cat: Class IIa
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โ
Uganda
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APPROVED |
| Device |
Bandage Roll
Wound Dressings - Class A - Bandage, elastic
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Mfr: Algiers Medical Devices
Cat: Class A
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Algeria
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PENDING |
| Device |
CardioCheck ECG Monitor
Cardiac monitoring equipment - Class B - Electrocardiograph (ECG) monitor
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Mfr: CardioScan Devices
Cat: Class B
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โ
Malawi
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PENDING |
| Device |
CathFlex PTCA Catheter
Cardiovascular Catheters - Class D - PTCA catheter
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Mfr: Vascular Devices Co.
Cat: Class D
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โ
South Africa
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PENDING |
| Device |
DermaLight PDT
Phototherapy Equipment - Class B - Light source, photodynamic therapy
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Mfr: Dermatology Devices Corp
Cat: Class B
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โ
South Africa
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PENDING |
| Device |
Pacemaker HeartSync
Cardiac Pacemakers - Class D - Implantable Pacemaker
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Mfr: Cardiac Devices Inc
Cat: Class D
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โ
South Africa
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PENDING |
| Training |
Computational modelling and Simulation (Hybrid)
NRA
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โ
Uganda
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Planning | |
| Training |
Biostatistics (Online)
NRA
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โ
Uganda
|
Planning | |
| Training |
IVD pannel characterisation (In-person)
NRA
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โ
Uganda
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Planning |