bioaccess® runs first-in-human device trials in Costa Rica under Ley N.° 9234: an accredited Comité Ético Científico (CEC) must approve the protocol in writing, the project is then registered with CONIS, and the statutory 3% canon is budgeted from the outset. Two gates, one file, ~30–90 days.
bioaccess® is the First-in-Human CRO for Costa Rica: Miami headquarters, in-country operations, and the CONIS/CEC file. All biomedical research in Costa Rica is governed by the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234). The national clinical-research authority is CONIS (Consejo Nacional de Investigación en Salud), an organ of the Ministry of Health (Ministerio de Salud).