Our Certifications
MedyAfrica maintains strict compliance with both local and international healthcare standards. We ensure all medical equipment delivered to hospitals and labs is fully certified, safe, and calibrated.
Quality Assurance Certificates
All equipment we import and distribute is backed by accredited international certifications and local health clearances.
ISO 13485:2016
International Quality Standards
Scope: Quality Management Systems for Medical Devices
The global gold standard for medical devices. Our partner manufacturing centers operate strictly under ISO 13485, ensuring consistency in product design, development, production, and distribution.
CE Conformity
European Economic Area Standards
Scope: Safety, Health, and Environmental Protection
CE marking certifies that our diagnostic devices and ICU equipment comply with strict European directives, guaranteeing safety and performance for both clinical staff and patients.
FDA Clearance
US Food and Drug Administration
Scope: United States Medical Grade Standards
Many of our diagnostic systems and critical care patient monitors carry FDA 510(k) clearances, representing compliance with the most rigorous verification and validation audits in the world.
OCC Conformity
Office Congolais de Contrôle
Scope: Democratic Republic of Congo Import Standard
MedyAfrica complies fully with the import standards of the DR Congo. All medical devices are pre-inspected and certified for use inside Congolese healthcare facilities.
DRC Ministry of Health
Secrétariat Général à la Santé
Scope: National Healthcare Supplier Authorization
Fully licensed by the local ministry of health to import, sell, install, and service medical and laboratory instruments across all provinces of the Democratic Republic of Congo.
How We Guarantee Quality
Our strict protocols ensure that hospitals receive devices ready for clinical operation immediately upon delivery.
Supplier Verification
We audit and select partner brands that have active ISO and CE certifications, validating their clinical performance track records.
Import Inspections
All equipment batches go through rigorous import conformity checks by standard inspection bodies like OCC to guarantee authenticity.
Pre-Installation Testing
Before delivery, our biomedical engineers inspect, calibrate, and double-check each equipment unit in our Kinshasa facility.
On-Site Calibration
Once installed, the system undergoes standard clinical checks on-site. We train staff and provide authorized certificates of installation.
Patient Safety is Our Priority
Do you require detailed declaration certificates, test reports, or specific compliance documentation for a procurement tender? Get in touch with our regulatory compliance unit.