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.



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