Health Canada vs SAHPRA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of Health Canada (Canada) vs SAHPRA (South Africa).
Health Canada
Health Canada — Therapeutic Products Directorate
Canada
Health Canada regulates medical devices through a four-class risk-based system. Class I devices require an establishment license, while Class II-IV require pre-market review. Canada is an MDSAP partic…
Class I, II, III, IV
MDEL (Class I), MDL (Class II-IV)
- ▸Medical Device License (MDL)
- ▸MDSAP single audit program
- ▸Incident reporting via MEDDEV
- ▸Medical Device Establishment License (MDEL)
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…
Class A, B, C, D
SAHPRA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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