Medical Device Registration and Approval in Costa Rica

General country-specific regulatory information is provided on this page for medical device registration and approval in Costa Rica.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in 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.

SPECIAL REQUIREMENTS: Foreign Manufacture on-site audit, local test, or local clinical study is not required.

LOCAL FEES (New Application):

Class I – 10$ USD

Class II – 25$ USD

Class III & IV – 50$ USD

LOCAL FEES (Manufacture): N/A

LICENSE VALIDITY: Licenses issued in Costa Rica expire after five years.

LICENSE TRANSFER: License transfer is possible and will be considered as an  amendment.

AUTHORIZED REPRESENTATIVE: Foreign manufactures must appoint a legal authorized representative (AR) that is located in Costa Rica, and will be responsible for the registration process.

Other Central America and the Caribbean Countries: Belize, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama

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For detailed device-specific compliance information for each market, including Costa Rica, to expedite the preparation of your medical device or IVD registration application.

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Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.

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