SAHPRA
SAHPRA — South Africa Medical Device Regulatory Authority
South Africa
Last reviewed 2026-06-21
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 →§ FAQ
What is SAHPRA in South Africa?
SAHPRA (South African Health Products Regulatory Authority) is South Africa's regulatory authority for medical devices, replacing the former Medicines Control Council (MCC). SAHPRA uses a four-class risk-based system (A, B, C, D) aligned with IMDRF recommendations and requires device establishment registration and product listing for market access in South Africa.
MedFlux monitors SAHPRA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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