International Classification for Standards (ICS) code 67.080

RTCR 405:2007 Reglamento para Registro, Clasificación, Importación, y Control de Equipo y Material Biomédico (Costa Rican Technical Regulation (RTCR) No. 405:2007 "Regulations for the Registration, Classification, Importation and Inspection of Biomedical Equipment and Material") (19 pages, in Spanish)

The purpose of this technical regulation is to establish the requirements and processes necessary for the classification, registration, importation and inspection of biomedical equipment and material intended for human use. It applies to biomedical equipment and material and their accessories, as well as to mobile device software and applications (apps) for medical use, that are produced, imported or marketed in Costa Rican territory.