Pure ethics committee approval in Chile and Costa Rica: zero ministry bottleneck

If you are a US or EU MedTech or biotech founder staring at the US investigational device exemption (IDE) queue, the first question is usually wrong. The question is not “which Latin American country is fastest.” The question is which archetype of startup you are buying.

I am Julio Martinez-Clark, CEO of bioaccess®. Chile and Costa Rica sit in the first archetype: pure ethics committee approval. For early-phase medical device and many biopharma programs, an accredited ethics committee (CEC / IRB) is the gate that authorizes clinical operations at research sites. The Ministry of Health does not run a sequential scientific review of the protocol the way a classic agency IND path does.

This article is Part 1 of a three-part series on Latin America’s rapid-startup archetypes (Chile, Costa Rica, Panama, El Salvador). Part 2 covers parallel review in Panama and El Salvador. Part 3 is the selection matrix. Companion corridor overview: Latin America’s fast-track FIH corridor. General information only — not legal advice. Confirm the filing-day pathway before you lock a calendar.

The archetype in one sentence

In Chile and Costa Rica, you get to first-patient-in by clearing an accredited ethics committee — not by waiting for a ministry to finish a separate protocol science queue after ethics is done.

That does not mean “no paperwork” and it does not mean “no import file.” It means the protocol’s scientific and ethical authorization lives in the CEC / IRB layer. Import and site logistics ride on that clearance instead of sitting behind a second ministry protocol evaluation.

Chile: Ley 20.120, Decreto 114, and the 45-day CEC clock

Chile’s human-research frame is Ley 20.120 and its regulation, Decreto 114. Accredited Comités Ético Científicos (CECs) evaluate protocols under a statutory clock: 45 calendar days from a complete submission, with a single founded extension of 20 days available under the regulation. That clock is the planning number sponsors should put on the Gantt chart for ethics — not a marketing estimate.

For medical devices, the early-phase path is structurally different from a pharmaceutical IND-style review at ANAMED. Device studies sit outside ANAMED’s centralized pharma investigational-product review. The Instituto de Salud Pública (ISP) role that matters for startup is the investigational-device import / provisional research-use authorization that follows CEC clearance. In practice: get the accredited CEC letter first; then work the ISP import file on the back of that clearance. Do not model Chile as “Ministry evaluates the protocol for six months, then ethics starts.”

Operator implications for Chile:

• Pick an accredited CEC early and map its meeting calendar. The statute gives you a day count; institutional agendas still decide when your file is complete enough to start the clock.
• Spanish protocol, informed consent, and investigator’s brochure quality decide whether you burn the 45-day window on questions or clear it once.
• Treat ISP as the import / research-use authority after CEC — not as a second sequential protocol science gate in the ANAMED drug sense.
• Site director authorization under the Chilean regulation is a real step. Budget it after CEC (and after ISP when your product path requires it).

For device-specific ISP investigation vs commercial registro nuance, see our live notes on Chile ISP clinical trial path for medical devices and why ISP treats device and drug trials differently.

Costa Rica: CONIS-accredited CEC as the authorization to start

Costa Rica’s Biomedical Research Law (Ley N.° 9234) and its regulations put written approval from a CONIS-accredited Comité Ético Científico at the center of trial initiation. CONIS (Consejo Nacional de Investigación en Salud), under the Ministry of Health, accredits the committees and runs the national protocol registry. That is not the same thing as MINSA running a sequential scientific review of every protocol after ethics.

For sponsors evaluating FIH / early feasibility outside the US IDE queue, the operational read is:

• A CONIS-accredited local CEC approves the protocol in writing.
• The approved project is registered with CONIS before execution activities begin.
• MINSA does not insert a second, sequential ministry protocol science review of the kind that creates 6–12 month backlogs in sequential markets.

Phase I and certain ministry-housed CEC paths exist inside the Costa Rican system — confirm filing class on day one. For most early-phase MedTech and biotech founders comparing corridors, the archetype still holds: ethics accreditation is the authorization layer; CONIS registration is the national bookkeeping layer; you are not buying a ministry-after-ethics science queue.

Operator implications for Costa Rica:

• Confirm the CEC is CONIS-accredited before you translate a dossier for the wrong committee.
• Build the Spanish file to ICH-GCP and, for devices, ISO 14155 expectations the committee actually uses.
• Register with CONIS after CEC approval. Registration is not a substitute for the CEC letter.
• Model hospital / site institutional authorization separately from the CEC decision.

See also: Costa Rica FIH activation calendar (CEC, CONIS, canon) and the Costa Rica clinical trials hub.

What “zero ministry bottleneck” does and does not mean

Sponsors hear “only ethics” and invent two false stories. Correct both before you brief your board.

False story 1: There is no government involvement at all.
Reality: Chile still has ISP import / provisional research-use mechanics after CEC. Costa Rica still has CONIS accreditation and registration under the Ministry of Health structure. “Zero ministry bottleneck” means the ministry is not the sequential protocol-science gate that holds first-patient-in for half a year.

False story 2: Ethics is a rubber stamp.
Reality: Accredited CECs in both countries review risk-benefit, consent, insurance, investigator fitness, and protocol science. Incomplete Spanish files restart the clock. Pure-ethics archetypes are fast when the file is complete. They are not shortcuts around subject protection.

Who this archetype fits

US/EU MedTech and biotech founders evaluating FIH / early feasibility outside the US IDE queue usually fit Chile or Costa Rica when:

• You want a clear ethics clock you can put in a financing deck (Chile’s 45-calendar-day CEC frame is the cleanest statutory example).
• You accept that import / registry steps follow ethics instead of preceding a ministry protocol evaluation.
• Your program benefits from strong data-rigor perception (Chile) or solid Central American infrastructure with English-friendly operations (Costa Rica), without needing a ministry scientific co-signature on the protocol itself.

If your board or notified body specifically wants a national regulator’s concurrent protocol evaluation on the docket, look at Part 2 — Panama and El Salvador’s parallel-review archetype — not at stretching Chile or Costa Rica into something they are not.

Practical startup sequence (both countries)

1. Freeze the English protocol and IB; commission Spanish translations that a CEC can read without guessing.
2. Select the accredited CEC (Chile) or CONIS-accredited CEC (Costa Rica) and obtain the current submission checklist and meeting calendar.
3. Submit a complete ethics package: protocol, IB, informed consent, insurance, investigator CVs, site letters.
4. Track the statutory or committee clock from the complete-file date, not from the first email.
5. On favorable CEC decision, open the import / research-use file (Chile ISP) or CONIS registration (Costa Rica) without waiting for a ministry protocol science second pass that this archetype does not require.
6. Close site contracts, pharmacy / device custody, and screening only after the country-specific start conditions are documented.

How bioaccess® runs this archetype

bioaccess® has been the First-in-Human CRO for medical devices in Latin America since 2010. On Chile and Costa Rica files we treat the CEC package as the critical path, keep ISP import or CONIS registration on a parallel logistics track after ethics, and refuse to sell you a sequential ministry fantasy that is not in the statute. When Global Trial Accelerators™ or a country hub on bioaccessla.com already covers a filing detail, we link it rather than invent a new clock.

Next in this series: Parallel review models in Panama and El Salvador. Then the four-country selection matrix.

Talk with bioaccess® when you need a Chile or Costa Rica FIH dossier built for the ethics clock you actually have — not the US IDE queue you are trying to step around.