Regulatory approval of medical devices in Costa Rica

Regulatory approval of medical devices in Costa Rica

Medical device registration in Peru

*If your medical 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.

MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Costa Rica.

Medical device classification in Costa Rica

Determining the proper classification for your medical device is critical to ensuring a smooth registration process in Costa Rica. We have many years' experience with medical device classification and will be happy to assist you.

Costa Rica medical device market

Interested in Costa Rica medical device market? Let's go even deeper into the topic.

Finding Costa Rica Registration Holder

Companies without an establishment in Costa Rica are required to appoint an authorized representative (Costa Rica Registration Holder) as an in-country representative and liaison with the Ministry of Health of Costa Rica. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Costa Rica. We will help you find a reliable Registration Holder.

Registration dossier preparation for submission in Costa Rica acc. to articles 7, 8 and 9 of the Reglamento para el registro, clasificación, importación y control de equipo y material biomédico N° 34482-S

Registration dossier provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance with the Regulation 34482-S that sets out regulatory requirements for the registration documentation for different classes of medical devices. We will also advise you on device labeling requirements and IFU in accordance with regulations of Costa Rica.

Medical distributor qualification in Costa Rica

While your registration is being finalized, our distribution specialists can help you find and evaluate medical device distributors in Costa Rica. This will increase the chances of finding a partner who is qualified and able to effectively market your products in the country.

Additional information

Validity 5 years
Language Documents and Labeling must be in Spanish
Postmarket Surveillance Must report adverse events and device recalls.
Expected Time 6-8 months
Medical device registration in Peru

*If your medical 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.

MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Costa Rica.

Medical device classification in Costa Rica

Determining the proper classification for your medical device is critical to ensuring a smooth registration process in Costa Rica. We have many years' experience with medical device classification and will be happy to assist you.

Costa Rica medical device market

Interested in Costa Rica medical device market? Let's go even deeper into the topic.

Finding Costa Rica Registration Holder

Companies without an establishment in Costa Rica are required to appoint an authorized representative (Costa Rica Registration Holder) as an in-country representative and liaison with the Ministry of Health of Costa Rica. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Costa Rica. We will help you find a reliable Registration Holder.

Registration dossier preparation for submission in Costa Rica acc. to articles 7, 8 and 9 of the Reglamento para el registro, clasificación, importación y control de equipo y material biomédico N° 34482-S

Registration dossier provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance with the Regulation 34482-S that sets out regulatory requirements for the registration documentation for different classes of medical devices. We will also advise you on device labeling requirements and IFU in accordance with regulations of Costa Rica.

Medical distributor qualification in Costa Rica

While your registration is being finalized, our distribution specialists can help you find and evaluate medical device distributors in Costa Rica. This will increase the chances of finding a partner who is qualified and able to effectively market your products in the country.

Interested in market of Costa Rica?

Contact us!