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§ LATIN AMERICA

ISP

ISP — Chile Medical Device Regulatory Authority

Chile

ISP is the national regulatory authority responsible for medical device oversight in Chile. It manages device registration, market surveillance, and adverse event reporting within the Latin America regulatory framework.

DEVICE CLASSES

Class I, II, III, IV

APPROVAL PATHWAY

ISP registration

KEY REGULATORY FUNCTIONS

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

OFFICIAL WEBSITE

https://www.ispch.cl

MedFlux monitors ISP regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.

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OTHER REGULATORS IN Latin America