Real operational lessons from executing a first-in-human medical device trial in Chile — including hidden tender blockades, site selection strategies, and FDA data bridging.
March 28, 2026
12
min read
By
BioAccess Editorial Team
In short
Chile enables first-in-human medical device trials materially faster than the US FDA IDE pathway, with Comité Ético Científico (CEC) approval on a timeline that varies by study (we confirm it per protocol) (legal limit: 45 days (Decreto 114/2010, art. 18), extendable once by 20; Decreto Supremo (DS) 114/2010, Art. 18 No. 2), and no regulator fee. Tender blockades delay 70% of startups — but with the right workarounds, Chilean FIH data is FDA-accepted under 21 CFR 812.28 when structured correctly.
**Key Takeaways**
- • Chile enables FIH device trials materially faster than the US FDA IDE pathway, with ethics approval on a timeline that varies by study (we confirm it per protocol) (legal limit: 45 days (Decreto 114/2010, art. 18), extendable once by 20)
- • No regulator fee — Chile charges none; see our sample budget and LATAM vs. US/EU cost benchmark)
- • Tender blockades delay 70% of startups — learn workarounds before submitting
- • Chilean FIH data is FDA-accepted under 21 CFR 812.28 when structured correctly
- • Santiago's hospital network offers subspecialty surgical capability for complex device studies
**Who Is This For?**
This guide is for MedTech startup CEOs, VP Clinical Affairs, and regulatory strategists considering Chile as a destination for their first-in-human or early feasibility medical device study — particularly those needing FDA-submissible clinical data at lower cost and faster timelines.
Why Choose Chile for First-in-Human Medical Device Trials?
Chile has established itself as one of Latin America's most reliable destinations for first-in-human medical device trials. The country combines political stability, strong healthcare infrastructure, and a regulatory framework that enables FIH studies without the extensive pre-market review burden found in the United States or European Union.
For MedTech startups running their first clinical study, Chile offers a compelling value proposition: materially faster timelines and lower per-patient costs than equivalent US pathways, with clinical data that FDA accepts for regulatory submissions under established foreign data acceptance guidelines.
Speed vs US Timelines: The Chile Advantage
| Parameter | Chile | United States | Advantage |
|---|---|---|---|
| Ethics Approval | Varies by study; we confirm per protocol (legal limit: 45 days (Decreto 114/2010, art. 18, https://www.bcn.cl/leychile/navegar?idNorma=1032919), extendable once by 20) | Varies by study; we confirm per protocol (IRB + FDA IDE) | Faster |
| Time to First Patient | Varies by study; we confirm per protocol | Typically longer | Faster |
| Regulatory Complexity | Moderate | Very High | Streamlined |
What Is the Timeline from Ethics Approval to First Patient Dosing?
Understanding the exact timeline for a Chile FIH device trial helps sponsors plan resources and set investor expectations. Here is the typical sequence based on bioaccess® operational experience:
The Sprint to First Patient
- Weeks 1-2: Protocol finalization, investigator brochure completion, CEC submission package preparation
- Weeks 3-11: Comité Ético Científico (CEC) review and approval — (varies by study; we confirm per protocol) depending on device complexity (legal limit: 45 days (Decreto 114/2010, art. 18, https://www.bcn.cl/leychile/navegar?idNorma=1032919), extendable once by 20; DS 114/2010, Art. 18 No. 2)
- Weeks 5-7 (parallel): Device importation permit application, clinical trial insurance procurement, site contract execution
- Weeks 8-15: Site activation, investigator and coordinator training, EDC setup and validation (varies by study; we confirm per protocol, starting once the CEC approves and ISP authorizes the investigational device under Código Sanitario Art. 111 A)
- Weeks 11-17: Patient screening initiation, first patient enrollment, first device procedure (first patient typically in weeks 13-17)
- From first patient (weeks 13-17) through week 40+: Enrollment completion, follow-up visits, data lock, and FDA submission package preparation
The critical insight is parallelization: while the CEC reviews the protocol, bioaccess® simultaneously processes device importation, site contracts, and insurance — eliminating sequential delays that add time that varies by study (we confirm it per protocol) in countries with multi-track approval processes.
How Do You Navigate Chile Tender Blockades?
The single biggest operational pitfall that delays 70% of startups attempting FIH trials in Chile's public hospital system is the tender blockade (licitación). Chile's public hospitals procure medical supplies and equipment through a centralized tender system. Investigational devices that aren't on existing tender lists face procurement delays of 2-6 months.
**Critical Pitfall: Public Hospital Tender System**
If your investigational device requires components, accessories, or disposables not already on a public hospital's approved procurement list, you may face a study-specific delay while the hospital initiates a new tender process. This is the #1 reason FIH timelines slip in Chile.
Proven workarounds:
- Route through private hospital networks (Clínica Las Condes, Clínica Alemana, Clínica Santa María) that have independent procurement authority
- Map your device's components to existing tender categories — many devices can be classified under existing procurement codes
- Obtain emergency-use or research-use exceptions from hospital procurement offices with CEC approval documentation
- Pre-negotiate device supply agreements with hospital administrators before CEC submission
- Use bioaccess®'s established site relationships to identify tender-friendly procurement pathways
How Should You Select Sites and Recruit Patients in Santiago?
Santiago's metropolitan area (~7 million population) hosts Chile's most capable clinical research sites. Site selection for FIH device trials requires evaluating surgical capability, investigator experience, and procurement flexibility:
- Clínica Las Condes: Private hospital with US-standard facilities, established clinical research department, and independent procurement — ideal for avoiding tender blockades
- Hospital Clínico Universidad de Chile: Academic medical center with strong research culture and subspecialty surgical capability
- Clínica Alemana de Santiago: Private hospital with international patient experience and advanced imaging/surgical infrastructure
- Hospital del Salvador: Public hospital with experienced clinical research coordinators and ethics committee
- Instituto Nacional del Tórax: Specialized thoracic/cardiovascular center for cardiology device studies
Recruitment acceleration tip: Chile's patient referral networks are physician-driven rather than advertising-driven. bioaccess® leverages established KOL relationships to accelerate patient identification through specialist referral chains — achieving recruitment rates faster than cold recruitment approaches.
How Do You Bridge Chilean FIH Data to FDA Submissions?
Chilean FIH data is accepted by FDA under 21 CFR 812.28 (acceptance of foreign clinical data) — see our FDA acceptance guide for Latin American clinical data. The key requirements for FDA acceptance are:
- Study conducted under GCP (ISO 14155) with documented quality management system
- Data is scientifically valid — appropriate study design, endpoints, and statistical analysis plan
- Subject rights and safety were adequately protected — informed consent, ethics committee oversight, adverse event reporting
- FDA can validate the data through inspection if needed — complete audit trail, source documents, monitoring records
bioaccess® structures all Chilean studies to produce FDA-submissible data packages including — for the full framework, read our FDA acceptance guide for Latin American FIH studies:
- 21 CFR Part 11-compliant EDC with complete audit trails
- Source data verification documentation for 100% of critical data points
- Statistical analysis using FDA-accepted methodologies
- Clinical study report (CSR) formatted per ICH E3 guidelines
- Regulatory submission package suitable for IDE, 510(k), De Novo, or PMA pathways
**FDA Bridging Checklist**
Before starting your Chile FIH, confirm: (1) your protocol includes FDA-required endpoints, (2) your EDC meets 21 CFR Part 11, (3) your monitoring plan includes source data verification, (4) your statistical plan aligns with the planned US regulatory pathway, and (5) your informed consent process meets both Chilean CEC and US FDA requirements.
Frequently Asked Questions
BA
bioaccess® · A CRO purpose-built exclusively for first-in-human clinical trials across Latin America. 50 companies accelerated since 2010.
Ready to Start Your First-in-Human Device Trial in Chile?
Chile's combination of regulatory speed, cost efficiency, surgical infrastructure, and FDA data acceptance makes it one of Latin America's top destinations for FIH medical device trials. With the right operational partner, you can avoid tender blockades, accelerate recruitment, and generate FDA-submissible clinical data in under 12 months.
Related resources:
- First-in-Human CRO Services — /first-in-human-cro
- Early Feasibility Studies — /early-feasibility-studies
- Clinical Trial Calculator — /clinical-trial-calculator
- INVIMA Approval Process Colombia — /blog/invima-clinical-trial-approval-process-colombia
- EFS CRO Latin America — /blog/early-feasibility-study-cro-latin-america