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: The Ministry of Health is the competent authority for medical and in-vitro diagnostic devices in Costa Rica.
Medical devices are divided into four classes (I, IIa, IIb and III) depending on the risk level.
Medical devices are registered in Costa Rica within a period of 6-8 months. Review timelines depend on the class of the device.
Licenses issued in Costa Rica expire after five years.
An authorized representative is required.
Last updated on February 9 2015.
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