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Medical devices are regulated by the ISP (Instituto de Salud Pública
or Public Health Institute).
Risk-based classification rules exist, but are not currently implemented.
The approval process takes 2-3 months. IVD devices require local testing, which can take up to one year.
Licenses issued in Chile are valid until the expiry of the device’s first relevant certificate (FSC, IO 13485, LoA).
An authorized representative is required.
Last updated on January 22, 2018.
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For more information on registration in Chile, check out the following articles on our blog:
Country at a Glance: Chile