*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.
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.
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 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.
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.
| 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 |
*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.
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.
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 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.
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.
