REGULATORY AUTHORITY:
Medical devices and in vitro diagnostic devices (IVDs) are regulated by the Ministry of Health (Ministerio de Salud), which is the competent authority responsible for registration, control, surveillance, and enforcement of biomedical equipment and materials (EMB) in Costa Rica.
CLASSIFICATION SYSTEM:
- Medical devices: Class I, Class II, Class III, and Class IV
- IVDs: Class I, Class II, Class III, and Class IV
TIMEFRAME:
- Medical devices & IVDs:
-Official timeline (Phase 2): ~2–4 months
-Actual timeline: ~6–8 months on average
Review timelines depend on the risk class, completeness of the dossier, and response time to authority queries.
LICENSE VALIDITY:
Licenses (Registro Sanitario) issued in Costa Rica are valid for 5 years for all classes of medical devices and IVDs.
LOCAL FEES (New Application):
- Medical devices & IVDs:
– Class I: USD 10
– Class II: USD 25
-Class III: USD 50
-Class IV: USD 50
(Fees are fixed by regulation and apply equally to medical devices and IVDs.)
LICENSE TRANSFER:
License transfer is permitted and is considered a license amendment. Prior approval from the Ministry of Health is required before implementation of the transfer.
AUTHORIZED REPRESENTATIVE:
A Local Authorized Representative (AR) is mandatory.
Foreign manufacturers must appoint a legal representative located in Costa Rica, who acts as the license holder and is responsible for the registration process and regulatory compliance.
ADDITIONAL INFORMATION:
- Class I biomedical equipment and materials (EMBs) no longer require sanitary registration for commercialization and use under Decree No. 403902-S (effective September 9, 2023); however, they remain subject to import, labeling, advertising, surveillance, and control requirements.
- Class II, III, and IV devices require sanitary registration.
- Local clinical studies are not required (local), but clinical evidence may be required for higher-risk devices unless an equivalency pathway applies.although clinical data may be requested for higher-risk devices.
- Costa Rica operates an equivalency program with the US FDA for Class III and IV devices, allowing reduced requirements and shorter review timelines for FDA-cleared/approved products.
- A mandatory admissibility stage (Resolution MS-DM-4164-2025) applies to new registrations, renewals, and amendments, ensuring formal completeness before technical review.
Other Central America and the Caribbean Countries: Belize, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama
