Chile
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.

Last updated on April 6, 2017.



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For​ more information on registration in Chile, check out the following articles on our blog:
Country at a Glance: Chile
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