Costa Rica pairs a mature MedTech manufacturing ecosystem with a defined Ministry of Health (Ministerio de Salud) / CONIS clinical-research pathway. bioaccess® designs FIH device programs to ISO 14155 and generates data eligible for FDA submission under 21 CFR 812.28 — at roughly 30% lower cost than a comparable US or EU program.
Costa Rica hosts one of Latin America's most advanced MedTech manufacturing clusters and a defined clinical-research pathway administered by the Ministry of Health (Ministerio de Salud) with oversight from the National Council of Health Research (CONIS).
First-in-human device programs run under ISO 14155 (the FDA-recognized GCP standard for medical device investigations) and the Declaration of Helsinki, with ethics-committee review by an accredited CEC before enrollment.
bioaccess® coordinates Ministry of Health/CONIS interactions, ethics review, site qualification, monitoring, and import of the investigational device so sponsors get FDA-quality first-in-human data at roughly 30% lower cost than a comparable US or EU program.
The Ministerio de Salud and the Consejo Nacional de Investigación en Salud (CONIS) authorize clinical studies in Costa Rica. bioaccess® prepares complete regulatory dossiers and coordinates directly with the agencies through study start-up.
Every study must be approved by an accredited ethics committee (CEC) before enrollment can begin. Ethics review follows ISO 14155 and the Declaration of Helsinki.
Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from Costa Rica for IDE submissions and marketing applications when studies are conducted under ISO 14155 with proper Ministry of Health/CONIS authorization and ethics approval.
| Metric | Costa Rica 🇨🇷 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory authority | Ministry of Health / CONIS | FDA | EMA / national CAs |
| Ethics review | Accredited CEC | Local IRBs | Per-country ECs |
| Standards followed | ISO 14155 + Declaration of Helsinki | 21 CFR / ICH-GCP | ICH-GCP / EU MDR |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
| Cost vs. US program | ~30% lower | Baseline | ~15–25% lower |
Regulatory details reflect published national frameworks; timelines and costs vary by device complexity, therapeutic area, and monitoring requirements. bioaccess® confirms the current pathway for each program.
The Ministry of Health (Ministerio de Salud), with oversight from the National Council of Health Research (CONIS), is Costa Rica's national authority for clinical research.
Every study must be approved by an accredited ethics committee (CEC) before enrollment begins. Ethics review follows ISO 14155 and 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 Ministry of Health/CONIS authorization and ethics approval.
Costa Rica programs typically run ~30% lower than a comparable US or EU program. Actual cost depends on device complexity, indication, monitoring intensity, and sample size.
Costa Rica combines a mature MedTech ecosystem, a defined Ministry of Health/CONIS pathway, ISO 14155-aligned ethics review, and ~30% lower program cost than US/EU baselines.
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