Costa Rica medical device & IVD approval process

Medical device registration in Costa Rica

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Medical 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 below 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 or IVD* 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 except Class I, 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 except Class I, obtain a Certificate of Free Sale (CFS) or a Certificate to Foreign Government (CFG) from the country of origin. This must be apostilled 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 except Class I, 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 except Class I, 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
Class I devices may be marketing in Costa Rica. For Class II-IV devices, 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.

© 2019 Emergo by UL
Chart updated: 08/2019

* The Ministry of Health will not authorize for public sale certain IVDs classified under Articles 4.3.12.4 and 4.4.10 of Decree 34482, including IVDs intended to detect HIV, Hepatitis B/C/D, HTLV, or other sexually transmitted or infectious agents in cerebrospinal fluid or blood. These products can still be registered and commercialized within Costa Rica, but cannot be sold for home or lay use.

** Class I devices do not require registration prior to import or commercialization per Decree 41387-S. Class I devices must still fulfill the minimum safety and efficacy requirements set forth in Decree 39342-S, including post-market vigilance and adverse event reporting.

*** Legal documents requiring apostille or consularization also require a certificate from a local Notary Public declaring the digital versions to be true and accurate copies of the original documents. See Article 10 of Regulation No. 37988-S.

**** Although Class I products do not require registration, foreign manufacturers of Class I products must still declare an import partner to facilitate importation and clearance through Customs.

***** 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.