An early feasibility study in Costa Rica runs as a first-in-human device investigation under Ley N.° 9234: accredited CEC written approval, CONIS registration, the 3% canon in the budget, and the import permit sequenced. bioaccess® builds the EFS for the FDA conversation from day one.
An early feasibility study (EFS) in Costa Rica is a first-in-human device investigation conducted under the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234). The authorization sequence: an accredited Comité Ético Científico (CEC) must approve the protocol in writing before enrollment, and the approved project is then registered with CONIS (Consejo Nacional de Investigación en Salud), the national clinical-research authority and an organ of the Ministry of Health.