First-in-Human Medical Device Trial in Chile: Operational Timeline and Pitfalls from Real-World Execution

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

Chile

first-in-human

medical devices

clinical trials

FDA

ISP

Latin America

**Key Takeaways**

• • Chile enables FIH device trials materially faster than the US FDA IDE pathway, with ethics approval in 4-8 weeks
• • Total costs are 30-40% lower — $12K-$22K per patient vs $25K-$50K+ in the US
• • 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 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 Costs: The Chile Advantage

Step-by-Step Timeline: Ethics 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 12-Week Sprint to First Patient

• Weeks 1-2: Protocol finalization, investigator brochure completion, CEC submission package preparation
• Weeks 3-6: Comité Ético Científico (CEC) review and approval — typically 4-8 weeks depending on device complexity
• Weeks 5-7 (parallel): Device importation permit application, clinical trial insurance procurement, site contract execution
• Weeks 7-10: Site activation, investigator and coordinator training, EDC setup and validation
• Weeks 10-12: Patient screening initiation, first patient enrollment, first device procedure
• Weeks 12-40+: 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 2-3 months in countries with multi-track approval processes.

Navigating Chile Tender Blockades: Real Lessons

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 2-6 month 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

Site Selection and Recruitment Hacks 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 2x faster than cold recruitment approaches.

Bridging Chilean FIH Data to FDA Submissions

Chilean FIH data is accepted by FDA under 21 CFR 812.28 (acceptance of foreign 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:

• 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.

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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.

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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