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.

Other South American Countries:

Argentina, Brazil, Colombia, Ecuador, Peru, Uruguay, Venezuela

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