General country-specific regulatory information is provided on this page for medical device registration and approval in Chile.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Medical devices are regulated by the ISP (Instituto de Salud Pública or Public Health Institute).
CLASSIFICATION SYSTEM: Risk-based classification rules exist, but are not currently implemented.
TIMEFRAME: The approval process takes 2-3 months. IVD devices require local testing, which can take up to one year.
LICENSE VALIDITY: Licenses issued in Chile are valid until the expiry of the device’s first relevant certificate (FSC, IO 13485, LoA).
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
Other South American Countries: Argentina, Brazil, Colombia, Ecuador, Peru, Uruguay, Venezuela
For detailed device-specific compliance information for each market, including Chile, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
