Costa Rica FIH Activation Calendar: CEC, CONIS Registration, and the 3% Canon

Most first-in-human (FIH) calendars I see for Costa Rica start on the wrong clock. Teams treat CONIS as a single “ministry approval” and then wonder why first-patient week slips after ethics is already in the file. Costa Rica is a two-gate country: a CONIS-accredited Comité Ético Científico (CEC) must give written approval before an interventional protocol can start, and the approved project is then registered with the Consejo Nacional de Investigación en Salud (CONIS). Those are different legal acts. If you collapse them, you are not planning activation — you are hoping.

This is an activation calendar, not another “how to run a trial in Costa Rica” tour. It is written for the RA lead who has to put first-patient-in (FPI) on a board that finance and the FDA pre-sub team will actually use. Ranges below are practitioner planning ranges for 2026 device programs. They are not CONIS service-level agreements.

The legal stack you actually file against

The statute is Ley N.° 9234, Ley Reguladora de Investigación Biomédica (in force 25 April 2014; SCIJ current text). Article 1 covers biomedical research with human beings in public and private settings. The law creates CONIS as an independent ethical, technical and scientific body attached to the Ministerio de Salud, with maximum deconcentration. Article 46 lets a public or private entity that hosts research constitute a CEC, provided CONIS accredits it. The same article requires the Ministry of Health to constitute a CEC that is responsible for approving Phase I clinical trials nationally, and for protocols from investigators or entities that do not have their own accredited CEC.

CONIS’s own CEC page repeats those points and cites the implementing reglamento, Decreto Ejecutivo N.° 39061-S, plus the reform Decreto N.° 39533-S. CONIS’s legislation index also lists the organic reglamento of CONIS (Decreto N.° 40884-S), the 22 September 2020 Gaceta repeal of Article 18 of Ley 9234, the CCSS biomedical-research reglamento for Caja sites, and — on the international list — the ICH E6 addendum, CIOMS, Helsinki, and related instruments. For a medical-device FIH, treat ISO 14155 as the device GCP you will later defend to FDA under 21 CFR 812.28; do not assume a drug ICH E6 binder substitutes for a device investigator brochure and risk-management file.

Ley 9234 is explicit that a protocol needs written approval from an accredited CEC before it starts, and that if the site is a public health institution the corresponding institutional authority must also authorize the work. No public or private authority may waive that sequence. That is why “we already have a U.S. IRB letter” does not start screening in San José.

What “Phase I” means for a device FIH

Decreto 39061-S defines Phase I in drug language: first introduction of a medicine into humans. Device sponsors still get caught by the institutional rule in Ley 9234 Article 46: the Ministry of Health CEC is the national Phase I committee. If your protocol is truly first-in-human — novel energy, a first implant, a first intra-cardiac or CNS contact — plan the ethics path as the Ministry CEC unless CONIS or the accredited committee you asked has confirmed in writing that a site CEC may take it. Guessing here is how a four-week ethics slot becomes a resubmission.

Independent investigators and entities without a CEC may submit to any CONIS-accredited CEC. Site CECs must be independent of the host and resourced to do the job. CONIS publishes the accredited-CEC list; if your chosen committee is not on it, you do not have an ethics clock.

The sequential activation calendar

Build the critical path as gates, not as a single “Costa Rica 60–90 days” slogan. The following is a 14–20 week FPI plan for a complete Spanish dossier at a private site that already has an accredited CEC. Public / CCSS sites add an institutional-authorization lane.

Weeks 0–3 — lock the Spanish file before anyone books a CEC slot. Protocol, investigator brochure, informed-consent forms, insurance certificate, investigational-device description and risk analysis, manufacturing / sterility story, PI CV and GCP training, site feasibility, and the signed budget that will later support the CONIS canon. Ley 9234 requires the CEC to send CONIS a copy of the signed contract when the project is registered. If the budget in the ethics pack and the budget used for the 3% canon do not match, registration stalls after you thought you were approved.

Weeks 3–8 — CEC review. Decreto 39061-S Article 44 requires a defined submission package before any experimental, clinical or interventional study starts. Subsequent reforms to that reglamento have treated the CEC pronouncement window as one calendar month counted from the business day after a complete filing. Treat “one month” as the first-cycle target only if the file is complete and the committee does not issue queries. Device FIH files that arrive with an English brochure, an unsigned insurance binder, or a consent that does not match the protocol lose that month. Practitioner planning for a first-in-human implant is 4–8 weeks of ethics time including one query cycle — still faster than a U.S. IDE, still not automatic.

Weeks 5–10 (parallel, not after CEC). Translate and legalize what CONIS will need to register the approved project. Open the insurance policy to Costa Rican law and local claim service. Start site contracts and the investigational-device import / customs file. Costa Rica does not give you a U.S.-style IDE number that magically clears every carton. Label units as investigational, limit quantity to the protocol, and keep the importer of record aligned with the sponsor entity that will appear on the CONIS register.

Weeks 8–12 — CONIS registration and the 3% canon. Ley 9234 requires the principal investigator, when registering an approved biomedical-research project, to pay CONIS a sum equal to 3% of the total research budget. Decreto 39061-S (canon provisions, as reformed) makes CONIS responsible for verifying that payment and depositing it to the CONIS collection account. Independent, non-commercial research can be treated differently; a sponsored device FIH is not that case. Do not treat the canon as a “CRO fee.” It is a statutory levy on the study budget at registration of the approved project. Build it into the budget before you sign the site. Registration is not a substitute for CEC approval, and CEC approval is not a substitute for registration.

Weeks 10–14 — institutional green light and site activation. If the site is CCSS or another public provider, Ley 9234’s institutional-authorization requirement is a real gate. The CCSS biomedical-research reglamento sits on CONIS’s legislation list for a reason. Private sites still need the legal representative of the institution to authorize the study — Resolución-style “IRB only” thinking is incomplete. Then SIV, device accountability, EDC, and the first screening visit.

Weeks 14–20 — FPI. First procedure only after CEC written approval, CONIS registration (and canon), institutional authorization, and release of investigational units. If any one of those four is missing, you do not have an activation date. You have a slide.

What actually belongs in the CEC package

Decreto 39061-S Article 44 is the index, not your U.S. IDE table of contents. In practice a device FIH package that survives first review contains:

• Spanish protocol with a Costa Rican PI who can defend first-human risk, stopping rules, and follow-up.
• Investigator brochure and IFU that define expected adverse device effects in the same language the consent uses.
• Informed consent that a CONIS-accredited CEC can read as Ley 9234-compliant, not a translated U.S. IRB form with the letterhead swapped.
• Insurance that names the Costa Rican site and participants, not only the Delaware sponsor.
• Device identification (model, lot/serial logic, sterility, remaining risks) consistent with ISO 14155 investigational labeling.
• Signed budget / contract copy the CEC can forward to CONIS for the canon calculation.
• Evidence the chosen CEC is CONIS-accredited — or a written path to the Ministry of Health CEC for Phase I.

CONIS’s international list includes ICH E6. That does not mean a drug monitoring plan is enough for an implant. If you later want FDA to look at the file under 21 CFR 812.28, the study must be scientifically valid, conducted under GCP, and inspectable. Build source documents and device accountability as if an FDA investigator will ask for them. Costa Rica’s law does not forbid that discipline. Sloppy EDC does.

What slips FPI after “ethics is approved”

Three failures repeat. First, the sponsor pays the 3% canon on a draft budget and then amends the contract up; CONIS has a different number than the CEC. Second, the site is public and nobody owned the institutional letter. Third, investigational units arrive with commercial labeling or a quantity that does not match the registered protocol. None of those are CONIS “delays.” They are activation defects.

A fourth defect is quieter: treating Costa Rica as a one-country shop and then changing the intended purpose so the same device can be registered later under RTCR 505:2022. Registration and FIH are different files. If the indication you implant is not the indication you will later put on a Costa Rica Registration Holder dossier, say so now. Do not let the activation calendar inherit a commercial story you have not written.

A one-page gate before you book travel

Write eight lines with an owner and a document ID. Do not announce FPI week until each line is true.

1. Intended purpose in Spanish that will appear in the protocol, brochure, and consent.
2. Phase I / first-in-human call: Ministry of Health CEC versus a named CONIS-accredited site CEC, in writing.
3. Complete Article 44 package, in Spanish, with insurance and budget attached.
4. CEC written approval (and query closure).
5. Institutional authorization if the site is public or otherwise requires it under Ley 9234.
6. CONIS registration of the approved project.
7. 3% canon paid on the same budget the CEC forwarded.
8. Investigational units released against the registered protocol, labeled as investigational.

If those eight lines cannot be signed in one sitting, you do not have a Costa Rica activation calendar. You have a hope that “LATAM is faster.” The statute is faster than a U.S. IDE when the file is complete. It is not faster than a missing CEC letter.