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 on 25 February 2026 (Resolución Exenta N° 2504571679) for a three-year term through February 2029 — holds ordinary sessions on Tuesdays and Thursdays, year-round, including February, skipping only Chilean public holidays (98 ordinary sessions in the year to May 2026). Ordinary sessions sit with full quorum. Extraordinary sessions run two to three times a week (currently Monday, Wednesday and Friday) with a reduced quorum, and are used for later filings after the initial review, such as data-monitoring or other safety notifications. Submissions are handled on the committee's digital platform, Ekomite®. Published 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 Memoria Anual / Cuenta Pública 2026 (https://iclaserenaresearch.cl/wp-content/uploads/2026/07/MEMORIA-ANUAL-CEC-ICLSR-2026.pdf).
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 document review but is required before the final opinion letter is released. Team credentials can be uploaded to the committee's Ekomite® platform. Every document, especially patient-facing materials, should carry a version and a date. An English investigator's brochure is acceptable at first submission, with the Spanish version to follow. Additional consent forms and participant materials may follow after initial submission but before recruitment starts; the opinion letter may note that those items are still awaited. Amendments require clean and tracked-changes versions of the protocol, brochure, and consent form, plus proof of payment. A complete informed consent that already contains the required minimums is what typically allows a direct approval. Under the committee's published rules, three consecutive unsatisfactory answers to the same objection or document can lead to administrative rejection, and continuing review uses a six-monthly progress report (CEC-ICLSR Memoria Anual 2026).
Beyond the document list, a first-in-human or interventional device file should already answer the questions an accredited Chilean CEC typically walks through before it sits: post-procedure nutrition and activity; what the participant should do in a low or high blood-sugar event, or the indication's equivalent safety events; concomitant and over-the-counter medicines; lifestyle restrictions written in the informed consent; clear first-in-human language; and whether the investigator's brochure contains the preclinical results the protocol relies on.
Last reviewed: 10 November 2026.