In order to register your medical device for sale in Costa Rica, you must first obtain approval for your product from the Costa Rican Ministry of Health.
Appointing an in-country representative and properly classifying your device according to the Ministry of Health’s four-tier classification system are the first steps for market entry in Costa Rica.
Device Classification in Costa Rica
Costa Rica has a four tiered classification system which is based on Health Canada’s classification rules. The Costa Rican Ministry of Health also leverages Health Canada’s grouping criteria. Class I and II medical devices in Costa Rica have a simplified registration process, while Class III and IV devices will have higher requirements, such as clinical studies performed for the device. However, if you have listing, clearance or approval with the US FDA for your device, then your Class III or IV device is eligible for the simplified registration process (similar to the Class I and II requirements).
Once approved, registrations are valid for five years.
From our office in San Jose, Emergo can fully support your registration effort in Costa Rica. We can fully address medical device classification and registration requirements put forth by the Ministry of Health and ensure a cost-effective and efficient path to market for your product in Costa Rica.