Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
Costa Rica's clinical-research authority is CONIS (Consejo Nacional de Investigación en Salud), an organ of the Ministry of Health (Ministerio de Salud). Trials are governed by the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234), require approval from an accredited scientific ethics committee (Comité Ético Científico, CEC), and are conducted under ICH-GCP / ISO 14155. bioaccess® runs Costa Rica as part of a multi-country FIH platform — not a single-country shop — anchored in U.S. FDA regulatory strategy.
Costa Rica pairs a mature MedTech manufacturing ecosystem with a well-defined clinical-research pathway administered by CONIS (Consejo Nacional de Investigación en Salud), an organ of the Ministry of Health (Ministerio de Salud). The framework is codified in the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234), which sets out sponsor, investigator, ethics-committee, and participant-protection obligations.
First-in-human device programs are conducted under ICH-GCP and ISO 14155 (the FDA-recognized GCP standard for medical device investigations), with ethics-committee review by an accredited Comité Ético Científico (CEC) before enrollment. Typical ethics and regulatory approval runs in the ~30–90 day range, and approved studies pay a statutory 3% CONIS canon (levy) on the study budget.
bioaccess® coordinates the full stack — CONIS submission and interactions, CEC ethics review, site qualification and monitoring, and import of the investigational device — so sponsors get FDA-anchored first-in-human data with a documented multi-country platform, rather than depending on a single-country shop.
CONIS (Consejo Nacional de Investigación en Salud) is the national clinical-research authority and operates as an organ of the Ministry of Health (Ministerio de Salud). All biomedical research in Costa Rica is governed by the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234), which defines sponsor obligations, investigator responsibilities, informed consent, ethics-committee accreditation, and inspection powers. bioaccess® prepares the full CONIS regulatory dossier and coordinates directly with CONIS through study start-up.
Before enrollment, every study must be approved by an accredited scientific ethics committee — Comité Ético Científico (CEC) — registered under Ley N.° 9234. Ethics review is conducted against ICH-GCP and, for medical devices, ISO 14155, with review of protocol, investigator brochure, informed consent, insurance coverage, and site qualifications. Typical combined ethics-plus-regulatory approval runs in the ~30–90 day range depending on device risk classification and dossier completeness.
Under Ley N.° 9234, approved biomedical research pays a statutory 3% CONIS canon (levy) on the study budget. bioaccess® builds this into sponsor budgets from the outset so there are no surprises at approval, and coordinates the required financial disclosures with CONIS.
Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from Costa Rica when studies are conducted under ISO 14155 with proper CONIS / Ministry of Health authorization and accredited-CEC ethics approval. bioaccess® designs Costa Rica protocols to FDA submission requirements from day one, so the resulting dataset supports Pre-Sub, IDE, 510(k), De Novo, PMA, and HDE pathways.
| Metric | Costa Rica 🇨🇷 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory authority | CONIS (Ministry of Health) | FDA | EMA / national CAs |
| Governing law | Ley N.° 9234 (Biomedical Research Regulatory Law) | 21 CFR | EU MDR / national frameworks |
| Ethics review | Accredited CEC (Comité Ético Científico) | Local IRBs | Per-country ECs |
| Study standards | ICH-GCP / ISO 14155 + Declaration of Helsinki | 21 CFR / ICH-GCP | ICH-GCP / EU MDR |
| Typical ethics + regulatory approval | ~30–90 days | 6–12 months (IDE + IRB) | 3–6 months (per-country CA + EC) |
| Statutory research levy | 3% CONIS canon on approved study budget | None equivalent | Varies by country |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
Regulatory details reflect Costa Rica's published national framework (Ley N.° 9234). Timelines vary by device complexity, therapeutic area, and dossier completeness. bioaccess® confirms the current pathway for each program.
Costa Rica-only specialist CROs are a good fit when Costa Rica is already the settled jurisdiction for your device, patient population, and FDA plan. They offer deep local focus and direct CONIS / CEC relationships.
bioaccess® runs your Costa Rica trial as part of a multi-country FIH platform — Costa Rica plus 9+ other Latin American markets, U.S. FDA regulatory anchoring (Pre-Sub, IDE, 510(k), De Novo, PMA, HDE, IND), and a documented FIH-to-Fortune-500 track record. If country choice is part of the strategy, that optionality de-risks site selection and enrollment.
See the full bioaccess® vs First In Humans comparison.
CONIS (Consejo Nacional de Investigación en Salud), an organ of the Ministry of Health (Ministerio de Salud), is Costa Rica's national clinical-research authority. All biomedical research is governed by the Biomedical Research Regulatory Law (Ley Reguladora de Investigación Biomédica, Ley N.° 9234).
Every study must be approved by an accredited scientific ethics committee — Comité Ético Científico (CEC) — registered under Ley N.° 9234. Ethics review is conducted against ICH-GCP and, for medical devices, ISO 14155.
Typical ethics-plus-regulatory approval in Costa Rica runs in the ~30–90 day range, depending on device risk classification and dossier completeness. bioaccess® manages the CONIS submission and CEC review in parallel to keep the critical path short.
Under Ley N.° 9234, approved biomedical research pays a statutory 3% CONIS canon (levy) on the study budget. bioaccess® builds this into sponsor budgets from the outset.
Studies are conducted under ICH-GCP and, for medical device investigations, ISO 14155 — the FDA-recognized GCP standard for devices — together with the Declaration of Helsinki.
Yes. Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from Costa Rica when studies are conducted under ISO 14155 with proper CONIS / Ministry of Health authorization and accredited-CEC ethics approval. (Eligibility for FDA submission and review — not a guarantee of clearance or approval.)
It depends on how settled your country choice is. If Costa Rica is clearly right for your device, patient population, and FDA plan, a Costa Rica-focused specialist with CONIS/CEC experience is a natural fit. If country choice is still part of the strategy — Costa Rica plus Panama, Colombia, Mexico, Chile, and other LATAM markets — bioaccess® gives you a documented multi-country platform with U.S. FDA regulatory anchoring under one FIH-only partner.
Last reviewed: July 2026
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