§ COMPARE REGULATORS

Medsafe vs SAHPRA: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of Medsafe (New Zealand) vs SAHPRA (South Africa).

Medsafe

Medsafe — New Zealand Medical Device Regulatory Authority

New Zealand

Medsafe is the national regulatory authority responsible for medical device oversight in New Zealand. It manages device registration, market surveillance, and adverse event reporting within the Asia-P

CLASSES

Class I, IIa, IIb, III

PATHWAY

Medsafe registration

KEY FUNCTIONS
  • 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

CLASSES

Class A, B, C, D

PATHWAY

SAHPRA registration

KEY FUNCTIONS
  • Device registration
  • Market surveillance
  • Adverse event reporting
  • Import/export control

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§ OTHER COMPARISONS