Medical device trials in Costa Rica run under Ley N.° 9234: accredited Comité Ético Científico review against ICH-GCP and ISO 14155, CONIS registration, a statutory 3% canon, and a sequenced import permit. bioaccess® is the device-trial CRO on that file.
Medical device clinical trials in Costa Rica are 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). Every study must be approved by an accredited scientific ethics committee — Comité Ético Científico (CEC) — registered under Ley N.° 9234, before enrollment.