FDA vs Medsafe: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of FDA (United States) vs Medsafe (New Zealand).
FDA
U.S. Food and Drug Administration
United States
The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enfo…
Class I, II, III
510(k), PMA, De Novo, HDE
- ▸510(k) clearance and PMA approval
- ▸MAUDE adverse event database
- ▸FDA Enforcement Reports and recalls
- ▸De Novo classification
- ▸Breakthrough Device Designation
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…
Class I, IIa, IIb, III
Medsafe registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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