bioaccess® runs medical device clinical trials in Venezuela — first-in-human, early feasibility, and traditional feasibility programs. We are the first CRO to establish clinical trial operations in the country. Two files, two authorities: INHRR (Instituto Nacional de Higiene “Rafael Rangel”), under the Ministry of Popular Power for Health (MPPS), authorizes the clinical investigation; SACS (Servicio Autónomo de Contraloría Sanitaria) handles commercial device registration at about 20 business days — a second, separate file. Institutional ethics review runs 6–10 weeks on early-phase studies. We run trials there — designed with FDA submission in mind under 21 CFR 812.28.
bioaccess® runs medical device clinical trials in Venezuela: Miami headquarters, in-country operations, the first CRO to establish clinical trial operations in the country. Device work here means two files with two authorities — and sponsors get in trouble when they confuse them.