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