General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.
What the law says (verified 29 October 2026)
Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. The rule for this country, from the primary text:
- Chile: Código Sanitario art. 111 F requires holders of the investigational-use authorization for drugs, or for devices in the classes a decree is to set (not yet issued), to carry civil liability insurance; art. 111 E makes them liable even for unforeseeable damage, presumes causation once damage is shown and sets a ten-year limitation period from when the damage manifests. Art. 111 A makes the policy part of the ISP application. On our reading, art. 111 F makes the policy a legally required insurance, which would bring it within DFL 251 art. 4 (insurance required by law may only be bought from insurers established in Chile). We found no CMF or ISP ruling on the point, and Hospital Clínico Universidad de Chile asks industry sponsors to name their representative in Chile rather than a Chilean insurer. The opposite reading is also arguable, because the policy’s terms await a regulation that hasn’t been issued, so confirm with a Chilean broker. Separately, the regulation of Ley 20.120 (DS 114/2010, art. 25, as amended by DS 30/2012) requires every protocol for scientific research in human beings under that law to set out the insurance and guarantees that apply to foreseeable and unforeseeable adverse events. We found no published Ministry regulation or device-class decree under art. 111 F as of 29 October 2026.
Ethics-committee practice (committee rules, not law): the accredited Chilean committees whose rules we read on 29 October 2026 all ask for the policy for clinical trials, several name device trials expressly, and none sets a minimum amount. CEC Salud UC requires cover through formal closure and the last follow-up (statement, March 2025). Universidad de Chile’s CEISH asks for “la póliza y certificado de seguro” for drug and device trials (Reglamento, Res. Exenta 697 of 30 October 2024). For industry-sponsored studies, Hospital Clínico Universidad de Chile asks you to name the Chilean representative and the policy period (requirements, March 2026). Hospital del Trabajador asks for a “póliza de seguro según normativa del ISP” for drug or implant trials (committee page). Universidad Mayor asks for a Spanish-language policy for the trial in Chile, plus separate cover if investigator malpractice is excluded (committee page). The full list, with Clínica Alemana–UDD and Clínica Las Condes, is in the hub guide.
None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.
If you searched Chile ISP clinical trial insurance, buy trial coverage Chile device FIH, ISP liability policy, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.
ISP authorizes studies and investigational-device import. An Ethical-Scientific Committee under Law 20.120 still has to sit. That committee will ask who pays if the investigational device injures the participant. The answer is a carrier form, not a CRO invoice.
This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: the insurance exhibit for ISP and Chilean ethics review. Same operator: the CRO runs the trial; a carrier writes the paper.
The CRO is not the carrier
Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:
- Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
- Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
- CRO. Protocol, IB, ICF, ethics and ISP submission, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.
Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.
ISP trial authorization is not commercial registro, and neither is a binder
None of the Chilean rules we read sets an insurance minimum. Some committees ask for a Spanish-language summary.
Santiago, Temuco, Antofagasta campuses are not insurers
Dermacross, Calvo Mackenna, Estudios Reumatológicos, Vanguardia Temuco, and Psicomed Antofagasta pages on this blog are sites. Do not email them for a binder. Institutional coverage is not sponsor trial-liability. See the site insurance versus sponsor policy page if that is the search — this page is Chile ISP.
What ethics and ISP actually ask for
Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. ISP trial authorization and commercial registration are different files — do not put them on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit.
Insurance documentation is usually in the ethics and ISP submission, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):
- Territory that names every country on the protocol.
- Site and principal investigator as additional insureds when the committee requires it.
- Policy period through last-patient last-visit plus the protocol follow-up window.
- Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
- Claims-notice language that can sit next to the SAE clock, not against it.
None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. The Chilean ethics-committee rules we read don’t set an amount either. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
A master that excludes Chile is useless. A Chilean local policy that cannot later add Colombia is a one-country trap. Ask the carrier which certificate they will issue for Law 20.120 ethics, in Spanish, with the PI named. Introduction is not a quote.
A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.
What bioaccess® still owns after you have a quote
- Regulatory-fit, not tourism. Chile is not a substitute for Colombia or Panama. We pick the country the device needs. bioaccess® still runs trials in Colombia.
- Protocol, IB, ICF, and the ethics and ISP submission with insurance documents in the same stack — not a parallel founder email.
- Importer of record and device accountability. A binder does not import the investigational product.
- Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
- Introducing a specialty carrier when the founder does not already have admitted paper. An introduction is not a partnership or a quote.
The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.
Frequently asked questions
Does bioaccess® sell clinical trial insurance?
No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind.
Is this the same article as the LATAM insurance hub?
No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page covers the ISP / Chilean ethics insurance exhibit.
Can a U.S. product-liability policy cover a LATAM device FIH?
Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.
Next step
If the search that brought you here was Chile ISP clinical trial insurance, start as the operator: contact bioaccess® or book from First-in-Human CRO. Chile operator page: Clinical Trials in Chile. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.
Julio G. Martinez-Clark, CEO · bioaccess®