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Costa Rica medical device approval process

Download the free chart: Costa Rican Regulatory Approval Process for Medical DevicesMedical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a few pathways to approval, and documentation requirements are different depending on your device's class. To see the differences between the classes, and to find out more about the medical device approval process with the Costa Rica Ministry of Health, please see or download the chart shown.

The Costa Rican medical device approval process explained

The chart shown illustrates a simplified version of the Costa Rican approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

Step 1
Determine the classification of your medical device using chapter II of Regulation No. 34482-S as published by the Costa Rican Ministry of Health. Typically the classification of your device matches the classification rules used in Canada: Classes I*, II, III, and IV

Step 2
For all devices, if you have no local presence in the country you will need to appoint a local company to act as your Costa Rica Registration Holder.

Step 3
For all devices, obtain a Certificate of Free Sale (CFS) or a Certificate to Foreign Government (CFG) from the country of origin. This must be Apostiled or consularized by the consulate of Costa Rica and be accompanied by an official translation in Spanish, completed by a certified translator located in Costa Rica.

Step 4
For all devices, designate an import partner, if different than your Registration Holder. Your partner will be named in your registration dossier.

Step 5
For all devices, prepare the application and registration dossier. This includes: technical and medical specifications, CFS and designation of import partner.

Step 6
For Class III and IV devices, a registration dossier should also include: a list of countries where the device is marketed, an overview of the manufacturer’s vigilance program, test reports, risk analysis, and summaries of clinical trial data. For Class IV devices, the clinical trial data must be published.
– OR –
If your Class III or IV device has FDA 510(k) clearance or premarket approval, and you can obtain a CFG from the FDA, your device will qualify for an abbreviated registration process.**

Step 7
For all classes, submit application and registration dossier to Ministry of Health for review and pay associated fees. All documents plus the IFU must be translated into Spanish. Ministry officials may request additional information before issuing a decision.

Step 8
The registration certificate will be sent to your Registration Holder. Registrations are valid for 5 years. You may now begin marketing your device in Costa Rica.

© 2017 Emergo Group.
Chart updated: 20/03/2017

* Some Class I devices do not require registration and may be imported immediately, but an optional registration exemption certificate may streamline the process and prevent Customs delays. See page 25 of Regulation No. 34482-S for a list of exempt devices.

** Costa Rica has an equivalency program with the US FDA. Under this program, manufacturers with FDA clearance or approval do not need to meet standard clinical trial requirements, and can submit a simplified registration dossier. These applications also qualify for an abbreviated review, generally cutting standard review times in half. In most cases, this process is only available to US-based manufacturers because the FDA only issues CFGs to companies exporting from the US.

This is a simplified overview of the process. The Ministry of Health may choose to audit your submission and request more documents, which will add time to your approval.