§ COMPARE REGULATORS

AIFA vs Medsafe: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of AIFA (Italy) vs Medsafe (New Zealand).

AIFA

AIFA — Italy Medical Device Regulatory Authority

Italy

AIFA is the national regulatory authority responsible for medical device oversight in Italy. It manages device registration, market surveillance, and adverse event reporting within the Europe regulato

CLASSES

EU MDR classes

PATHWAY

AIFA registration

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

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

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§ OTHER COMPARISONS