South Africa
South Africa is the reference market for medical devices on the African continent, with a diverse and growing healthcare system.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the South African Health Products Regulatory Authority (SAHPRA).
Device Classification:
- Class A: Low risk
- Class B: Moderate risk
- Class C: High risk
- Class D: Critical risk
Specific Local Requirements
| Language | Documentation in English. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | CE marking, FDA approval, or ISO 13485 certification is preferred. |
Challenges and Operational Advice
- Complex process: Timelines vary depending on the device’s risk class.
- Surveillance: Stringent post-market monitoring.
Why Choose ISEMED
- Africa Expertise
Targeted support for emerging markets. - Complete Management
Assistance with technical dossier and communication with SAHPRA.
FAQ
- Is a local representative required? Yes.
- Documentation language? English.
- License duration? 5 years.