Pilot and feasibility studies are where device designs get their first human answers — and Chile is built for exactly that. For medical device studies, an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) is the only protocol gate, with a 45-day decision clock: small, iterative, learning-focused studies move without a ministry queue.
A pilot study asks narrow questions — does the device deploy as designed, what does first human use reveal, which design iteration comes next — and it needs a regulatory path proportionate to those questions. Chile's device path is exactly that: for medical device studies, the protocol goes to one reviewer, an accredited Ethical-Scientific Committee, and the Ministry of Health does not review the protocol. The committee decides within 45 days of submission, extendable once by 20 days (Decreto 114/2010, art. 18, https://www.bcn.cl/leychile/navegar?idNorma=1032919) for founded reasons (Supreme Decree 114 of 2010).