§ COMPARE REGULATORS

AGES vs Medsafe: Medical Device Regulatory Comparison

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

AGES

AGES — Austria Medical Device Regulatory Authority

Austria

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

CLASSES

EU MDR classes

PATHWAY

AGES 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