bioaccess® runs first-in-human device trials in Panama. Decreto Ejecutivo 21 of 23 April 2026 put hard clocks on ethics review, MINSA runs its technical evaluation in parallel for higher-risk protocols, and a dedicated device-trial channel sits inside the Dirección Nacional de Dispositivos Médicos. The pathway is proven: a first-in-human implant trial was recently authorized at The Panama Clinic.
bioaccess® is the First-in-Human CRO for Panama: Miami headquarters, in-country operations, and the MINSA file. Panama's clinical-investigation framework is Ley 84 of 14 May 2019, and Decreto Ejecutivo 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) is its first implementing regulation — the country's first hard clocks on ethics review, with accredited Type II committees, RESEGIS registration, and MINSA technical evaluation running in parallel with ethics review for higher-risk protocols.