Medical Device Registration and Approval in Costa Rica

General country-specific regulatory information is provided on this page for medical device registration and approval in Costa Rica. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Costa Rica, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Costa Rica

 REGULATORY AUTHORITY: The Ministry of Health is the competent authority for medical and in-vitro diagnostic devices in Costa Rica.

CLASSIFICATION SYSTEM: Medical devices are divided into four classes (I, IIa, IIb and III) depending on the risk level.

TIMEFRAME: Medical devices are registered in Costa Rica within a period of 6-8 months. Review timelines depend on the class of the device.

LICENSE VALIDITY: Licenses issued in Costa Rica expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last updated on February 9 2015.

Other Central America and the Caribbean Countries:

Belize, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama

 

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