DKMA vs SAHPRA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of DKMA (Denmark) vs SAHPRA (South Africa).
DKMA
DKMA — Denmark Medical Device Regulatory Authority
Denmark
DKMA is the national regulatory authority responsible for medical device oversight in Denmark. It manages device registration, market surveillance, and adverse event reporting within the Europe regula…
EU MDR classes
DKMA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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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