Chile combines an established, high-quality research infrastructure with a defined regulatory pathway: ISP (Instituto de Salud Pública) authorizes medical studies and oversees medical products and investigational device import authorizations, and research on humans is governed by Law 20.120 with an accredited Ethical-Scientific Committee (Comité Ético Científico) written favorable review plus institutional authorization required before a study begins. With bioaccess®'s coordination, sponsors generate FDA-submissible data at ~30% lower cost than US/EU programs.
Chile has one of Latin America's most established and high-quality clinical research infrastructures, with a stable regulatory environment and rigorous ethics oversight. The Instituto de Salud Pública (ISP) is the national authority responsible for authorizing medical studies and overseeing medical products and investigational device import authorizations.
Research involving human subjects is governed by Law 20.120. Under this framework, an accredited Ethical-Scientific Committee (Comité Ético Científico) must issue a written favorable review and the host institution must authorize the study before it begins; the investigator then reports study progress and a final report to the committee. Chilean clinical research follows ISO 14155 and the Declaration of Helsinki.
bioaccess® coordinates ISP authorization, Ethical-Scientific Committee review, site qualification, and monitoring so sponsors get FDA-quality first-in-human data at roughly 30% lower cost than a comparable US or EU program. Chile is a strong single-country choice and a natural fit within multi-country LATAM programs.
The Instituto de Salud Pública (ISP) is Chile's national authority for authorizing medical studies. ISP oversees medical products and issues investigational device import authorizations, giving MedTech sponsors a defined regulatory pathway. bioaccess® prepares ISP submissions and manages agency correspondence.
Research on human subjects in Chile is governed by Law 20.120. Before a study begins, an accredited Ethical-Scientific Committee (Comité Ético Científico) must issue a written favorable review and the host institution must authorize the study. During the study, the investigator reports progress and a final report to the committee. bioaccess® coordinates the ethics package end-to-end.
Chile has an established, high-quality clinical research infrastructure with experienced investigators and hospitals accustomed to ISO 14155-aligned work. bioaccess® qualifies sites, trains study personnel on protocol-specific procedures, and provides on-the-ground monitoring for consistent, source-verified data.
Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from Chile for IDE submissions and marketing applications when studies are conducted under ISO 14155 with proper ISP authorization and Ethical-Scientific Committee approval. bioaccess® designs every protocol for FDA submission from day one.
| Metric | Chile 🇨🇱 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory authority | ISP (Instituto de Salud Pública) | FDA | EMA / national CAs |
| Ethics review | Ethical-Scientific Committee (Law 20.120) | Local IRBs | Per-country ECs |
| Device classification | Classes I–IV | Classes I–III | Classes I–III (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 |
| Time zone vs. US East Coast | Same / 1–2h offset | Same | +5 to +6 hours |
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 Instituto de Salud Pública (ISP) is Chile's national authority for authorizing medical studies and overseeing medical products and investigational device import authorizations.
Research on humans in Chile is governed by Law 20.120. Before a study starts, an accredited Ethical-Scientific Committee (Comité Ético Científico) must issue a written favorable review and the host institution must authorize the study, and the investigator reports progress and a final report to the committee.
Yes. Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from Chile when studies are conducted under ISO 14155 with proper ISP authorization and Ethical-Scientific Committee approval. bioaccess® designs protocols for FDA submission from the start.
Chile programs typically run ~30% lower than a comparable US or EU program. Actual cost depends on device complexity, indication, monitoring intensity, and sample size — bioaccess® scopes each program individually.
Chile combines a defined ISP pathway, risk-based device classification, rigorous Ethical-Scientific Committee review under Law 20.120, ISO 14155 alignment, and ~30% lower program cost than US/EU baselines.
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