For medical device studies in Chile, the protocol faces one reviewer: an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC). The Ministry of Health does not review the protocol — the single ethics gate, with published 2026 metrics showing an 8.6-day average for initial reviews against a 45-day legal ceiling, is the fastest first-in-human path in the region for devices.
Chilean law — Law 20.120 on scientific research in human beings and its regulation, Supreme Decree (Decreto Supremo) 114 of 2010 — requires every clinical study in human beings to pass ethical-scientific review by an accredited Ethical-Scientific Committee before it starts. For medical device investigations, that committee review is the protocol's only gate: the Ministry of Health does not review the device protocol itself.
Published committee metrics run well under the legal ceiling. CEC-ICLSR of IC La Serena Research — accredited 2023, re-accredited in February 2026 by the SEREMI de Salud of Coquimbo — holds ordinary sessions twice a week (98 in the year to May 2026) and publishes its review times: initial reviews average 8.6 days of committee work, 25.3 days total end-to-end; protocol amendments average 2.4 days (7.3 total). Source: CEC-ICLSR Cuenta Pública 2026.
Below is the published submission checklist of one accredited committee — CEC-ICLSR of IC La Serena Research (La Serena, accredited 2023) — as a concrete example of what the single-gate review requires; each accredited committee publishes its own list. For initial review it asks for: the protocol in English and Spanish; the current investigator's brochure; the main informed consent form; the insurance certificate; the insurance policy, or the policy number deposited with the CMF (Comisión para el Mercado Financiero); the participant study card (if applicable); the center director's authorization letter, the PI's commitment letter, and conflict-of-interest declarations on the committee's own formats; the research team roster (name, title/specialty, role); and proof of payment, which may arrive in parallel with the review. Additional consent forms and participant materials may follow after initial submission but before recruitment starts; amendments require clean and tracked-changes versions of the protocol, brochure, and consent form, plus proof of payment.