Medical device trials in El Salvador run under the SRS with centralized CNEIS ethics — and an operative good-clinical-practice inspection guide that expressly applies to device trials under ISO 14155. bioaccess® is the device-trial CRO on that file, on an honest 3–5 month clock.
Medical device clinical trials in El Salvador sit under the Superintendencia de Regulación Sanitaria (SRS), the autonomous national regulatory authority since August 2024 (successor to the Dirección Nacional de Medicamentos, DNM). Ethics review is centralized at the Comité Nacional de Ética de la Investigación en Salud (CNEIS), with SRS and CNEIS submissions running in parallel.