COFEPRIS vs Medsafe: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of COFEPRIS (Mexico) vs Medsafe (New Zealand).
COFEPRIS
Federal Commission for Protection against Health Risks (Mexico)
Mexico
COFEPRIS regulates medical devices in Mexico under the General Health Law. Mexico uses a three-class system (I, II, III). A sanitary registration (registro sanitario) is required for Class II and III …
Class I, II, III
COFEPRIS sanitary registration
- ▸Sanitary registration
- ▸FDA/EU recognition pathway
- ▸GMP compliance
- ▸Import permits
- ▸Vigilance reporting
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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