Costa Rica medical device approval process

Download the Chart on the Medical Device Approval Process in Costa RicaMedical 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.

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 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.

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 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 import partner will be named in your registration dossier, so you will need to complete this step before you can submit your application and dossier to the Ministry of Health.

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, overview of the manufacturer’s vigilance program, summary of published clinical trials including reference literature, test reports, risk assessment studies and reports for use, safety and efficacy. However, if you are a US-based manufacturer and your device has FDA 510(k) clearance or PMA approval it qualifies for an expedited approval process, and instead of the above documentation you may submit your CFG.

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 (as noted above). Ministry officials may request additional information before issuing a decision. Your prompt and complete response to their request(s) will affect the overall approval timeline.

Step 8
If approval is granted 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.

© 2014 Emergo Group.
Chart updated: 08/07/2014