: 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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