Every early-stage MedTech founder I meet has a slide that shows the “fastest” first-in-human destination in Latin America. The number on that slide is almost never the number that decides whether the study finishes. The number that decides it is whether the ethics clock, the import path, the investigator calendar and the patient pipeline all clear in the same month. When they do not, paper speed becomes calendar debt.
I’m Julio Martinez-Clark, CEO of bioaccess®. We have run first-in-human and early-feasibility device programs across Latin America since 2010. This article is about the trade-off founders actually face once the destination shortlist is on the board: absolute clock speed versus regulatory and operational certainty. It is not another tour of country gates. We already published that comparison as the LATAM rapid-startup archetypes series (Chile and Costa Rica pure-ethics; Panama and El Salvador parallel review). Here the question is different: what has to be true before you trust any of those clocks.
The trap of paper feasibility
Paper feasibility looks clean. A regulatory summary quotes a statutory ethics window. A site replies “we can start in 60 days.” A distributor says the import license is routine. The board hears a single number and treats it as a plan.
What breaks that plan in real programs is rarely the statute. It is the stack behind the statute:
- Hospital or site contracts that sit in a legal queue after ethics has already cleared.
- Import licenses and customs pathways for a custom or single-use delivery system that has never entered that country before.
- Competing protocol queues at the investigator’s procedure rooms, so your “activated” site has no open slots for first procedures.
- Incomplete Spanish packages that burn the first ethics cycle on queries instead of on a decision.
I have watched sponsors move to a secondary destination because the slide promised a shorter clearance, then lose a quarter waiting on an import annex or a site that had no eligible patients in the indication. The ethics letter arrived on time. First patient in did not. That is paper feasibility: a clock that only measures one desk.
If your feasibility pack does not name the ethics body, the import path, the investigator bandwidth and a concrete patient source for the protocol, you do not have a startup plan. You have a slogan.
What regulatory certainty actually means
Certainty is not the same thing as “slow.” Certainty means the review clocks are statutory or institutional, the roles of ethics and the health authority are published, and the file that leaves your team maps to those roles without improvisation.
In the fast corridor we already mapped, that looks like:
- Chile: Ley 20.120 and Decreto 114 put protocol evaluation in an accredited Comité Ético Científico (CEC) with a 45-calendar-day report clock (extendable once by 20 days for founded reasons). ISP’s role for investigational devices sits after that ethics clearance under Código Sanitario Article 111 A for provisional use authorization and import logistics — not as a second sequential ministry science queue on the protocol itself.
- Costa Rica: a CONIS-accredited CEC authorizes the biomedical research protocol under Ley 9234 and its reglamento; CONIS registration (and the statutory 3% research-budget canon) follows. There is no sequential ministry protocol-science gate in front of study start the way a classic IND path works. Costa Rica is also the Latin American country whose biomedical-research framework applies that statutory levy on the study budget; Chile’s pathway does not charge an equivalent regulator levy of that kind.
- Panama: Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) implements Titles III and IV of Ley 84 of 2019. High-risk clinical trials run ethics and MINSA evaluation in parallel through CNBI-accredited Type II committees and RESEGIS registration. Art. 102 calls for good laboratory practice (GLP) when preclinical studies are needed. Whether that covers preclinical work done abroad for a device has not been tested, so plan for GLP or a documented GLP gap analysis.
- El Salvador: SRS regulatory authorization and CNEIS ethics review operate through the coordinated SRS–CNEIS-ES submission path, so sponsors clear both desks without inventing a local process from scratch.
Those are certainty features: you can point to a published instrument and a known desk. They are not a promise that every incomplete file finishes in 30 days. Certainty is what lets you plan the non-regulatory work — contracts, import, enrollment — on the same calendar as the review.
Audit-ready data under 21 CFR 812.28 and ISO 14155
Speed is worthless if the dataset cannot support the next U.S. or European filing. For devices, FDA’s acceptance of foreign clinical investigations is framed in 21 CFR 812.28: the investigation must be well designed and well conducted, must follow good clinical practice, and FDA must be able to validate the data through an on-site inspection if needed. GCP in that rule includes independent ethics review and documented informed consent. ISO 14155 is the clinical-investigation standard most device sponsors already use to design that GCP layer.
What that means for destination choice:
- Pick sites and investigators who can produce monitoring, source, and adverse-event records that survive an FDA or Notified Body look-back.
- Do not treat a fast ethics letter as a substitute for a monitoring plan, a translation-controlled protocol package, or a data-management setup that matches the pivotal plan.
- If the FIH is meant to support an IDE, 510(k), De Novo or CE clinical evaluation, write that intended use of the data into the protocol and the quality plan before first procedure — not after the last follow-up visit.
We have written separately about whether Panama or El Salvador FIH data can support an FDA IDE, 510(k), De Novo or PMA. The short operator version: foreign data can help, but only when the investigation was built to 812.28 and ISO 14155 standards from day one.
The sequencing matrix: early speed and later depth
Most founders do not need one country to do every job. They need a sequence.
- Early feasibility or FIH in a corridor country where ethics and authority roles are published and startup can run without a multi-quarter sequential backlog — the archetypes above.
- Pivotal or larger confirmatory work planned in parallel for a market with depth of sites and a registration path you already intend to use commercially — often Brazil (ANVISA) or Colombia (INVIMA), sometimes Mexico (COFEPRIS).
- Import and quality continuity so the investigational units, labeling and device accountability rules stay coherent across both stages.
That is the same design logic as a two-country FIH strategy: one market buys a clean early clock; another buys redundancy and scale. The matrix fails when the early country was chosen only for a slide number and the pivotal country was never staffed for dossier work until the FIH was already behind.
On pricing: bioaccess® does not publish fixed public FIH prices. Any budget we show on bioaccessla.com is a sample budget for a typical first-in-human trial in Latin America, not a fixed-price offer. Your protocol, risk class, sites and import path set the real number.
A practical checklist before you lock a destination
Before the board votes on a country, make someone answer these in writing:
- Which accredited ethics body will review, and what is the published clock for a complete file?
- What does the national authority review for this protocol — product/import only, parallel protocol evaluation, or something else — and where is that written?
- Who holds the import license path for this specific device configuration, and has that path cleared a comparable shipment before?
- Which investigator has open procedure capacity in the next two quarters, and where do eligible patients come from (practice panel, hospital census, referral — named, not assumed)?
- Will the monitoring, consent and data package meet 21 CFR 812.28 / ISO 14155 expectations if FDA or a Notified Body asks later?
- If preclinical evidence is part of the Panama file, is it GLP, or do you have a documented gap analysis written against Decreto Ejecutivo 21 Art. 102?
If any answer is “we will figure it out after ethics,” you are buying paper speed.
How we run the conversation at bioaccess®
When a founder comes to us with a destination already chosen, we stress-test the file against that checklist. When the destination is still open, we map the protocol to the corridor archetypes, then to the sequencing matrix for the next filing. The podcast Global Trial Accelerators™ is where I walk founders through the same trade-offs in public. The private work is the feasibility memo: clocks, desks, import, enrollment and data use — on one page the board can read.
Fastest clock and most certain framework are not opposites when the framework is published and the operations behind it are real. They become opposites when the clock is the only thing you measured. Measure the stack. Then pick the country.
Evaluate your trial timeline against regional benchmarks and early-phase feasibility services at bioaccessla.com, or bring the protocol to a Global Trial Accelerators™ planning conversation and we will map the sequence with you.