Medical and in vitro diagnostic (IVD) device manufacturers who want to enter the Costa Rican market need to register their products with the Costa Rican Ministry of Health (MOH). Low-risk devices are not subject to registration but must still fulfill the minimum safety and effectiveness requirements defined by the MOH.
The Costa Rican medical device approval process explained
The chart illustrates the MOH approval process per device classification in Costa Rica and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.
Step 1
Determine the classification of your device using the MOH’s classification rules.
Step 2
For all except low-risk devices, appoint a local company to act as your Costa Rica Registration Holder. For all devices — including low-risk — designate an importer in Costa Rica.
Step 3
Obtain a Certificate of Free Sale (CFS) or a Certificate to Foreign Government (CFG) from the country of origin.
Step 4
Prepare the application and registration dossier for submission to the MOH.
Step 5
Pay the application fee. The MOH reviews the application and may request additional information.
Step 6
Upon approval, the MOH issues the registration certificate for your device.
Log in to RAMS to view the chart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for Costa Rica when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.
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