← All regulators
§ AFRICA
SAHPRA
SAHPRA — South Africa Medical Device Regulatory Authority
South Africa
SAHPRA is the national regulatory authority responsible for medical device oversight in South Africa. It manages device registration, market surveillance, and adverse event reporting within the Africa regulatory framework.
DEVICE CLASSES
Class A, B, C, D
APPROVAL PATHWAY
SAHPRA registration
KEY REGULATORY FUNCTIONS
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
OFFICIAL WEBSITE
https://www.sahpra.org.za →MedFlux monitors SAHPRA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
MONITOR {abbr} FREE →