Medical Device Registration and Approval in Chile
General country-specific regulatory information is provided on this page for medical device registration and approval in Chile. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Chile, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in 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 January 22, 2018.
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