Medical Device Registration and Approval in Costa Rica
ANSWERED ON THIS PAGE:
- How are medical devices classified in Costa Rica?
- What are the Costa Rica medical device registration requirements?
- Do we need in-country representation as a foreign device company?
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 classification system are the first steps for market entry. With a presence in San Jose, Emergo is equipped to assist with all aspects of the medical device registration process in Costa Rica.
Device registration requirements in Costa Rica
Costa Rica has a four-tiered classification system 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, Class II and IV devices that are listed, cleared, or approved with the US FDA are eligible for the simplified registration process, which is similar to the Class I and II requirements). Once approved, registrations are valid for five years.
Costa Rica in-country representation for foreign device manufacturers
Manufacturers without a location in Costa Rica are required to appoint a Registration Holder, a local entity to submit and hold their registration certificates. This certificate is issued in the entity’s name, and they will in essence “own” the approval on the market. Importers/distributors must be explicitly identified on the registrations in order to be able to import.
Emergo’s team in San Jose can assist with medical device registration in Costa Rica
Emergo can fully support your registration effort in Costa Rica. We can determine medical device classification and registration requirements put forth by the Ministry of Health as they apply to your product as well as ensure a cost-effective and efficient path to market for your product in Costa Rica.
Common Costa Rica registration questions
My Class III or IV device has approval in Mexico, and/or I have a medical device license from Health Canada. Does that mean my device qualifies for the simplified review process in Costa Rica?
Unfortunately, no. Even though the Costa Rica system leverages the Health Canada classification rules, the only way for your Class III or IV devices to qualify for the simplified registration process in Costa Rica is: listing, clearance or approval with the US FDA.