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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.
Last updated on November 23rd, 2021.
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.
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.
Any Questions?
Please fill out your contact information so we can better assist you.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.