🇨🇷Costa Rica Medical Device Regulations

Admissibility Procedure for Medical Device Registration Applications

Defines the Ministry of Health admissibility and deficiency-prevention procedure for registration submissions covering medicines and biomedical equipment and materials.

Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance

Core Costa Rican technical regulation covering medical device classification, registration, importation, labeling, advertising, vigilance, and market control, including medical software and mobile applications.

Medical Device Registration Renewal by Notification

Establishes the notification procedure used to renew sanitary registrations for Class 2, 3, and 4 biomedical equipment and materials.