Category: Preparing for First-In-Human Studies

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. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 EC IRB insurance certificate to start, ethics committee certificate of insurance clinical trial, IRB trial insurance LATAM, 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.

Start-up is often blocked on one PDF: a certificate of insurance the ethics committee will file. Not a binder number on Slack. Not a broker email that says “in process.” A certificate: named insureds, territory, period, language. bioaccess® puts it in the packet. We do not issue it.

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 ethics-committee certificate as a start-up gate. 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 committee / IRB 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.

What the clerk actually stamps

Committees in Panama (CNBI-registered), Chile (Law 20.120), Colombia, Mexico, Peru, Costa Rica, and El Salvador all vary. The common pattern: the policy is reviewed before approval, not as a post-approval souvenir. Two exceptions: in Mexico, since April 2025, COFEPRIS authorizes the protocol first and the policy or financial fund is filed within 15 business days after authorization (ethics committees may still ask for it earlier); in Brazil, CEP/CONEP don’t ask for proof of insurance (CONEP manual, 2015), although individual sites may. Missing additional insureds, English-only certificates, and periods that die before follow-up are the usual resubmissions.

Certificate versus binder versus MSA

A binder is the carrier’s temporary yes. A certificate is what ethics files. An MSA is the site contract. Start-up needs the certificate in the ethics PDF, not the MSA’s indemnity paragraph. This page is the start-up gate itself.

What ethics committees and IRBs actually ask for

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. Use Clinical Trials in Costa Rica. Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews the protocol first; then the study is registered with CONIS / the Ministry of Health. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. Confirm the current calendar with qualified advisers; an NCT location row is not CONIS registration. A 3% CONIS canon on the study budget is a legal charge under Ley 9234, art. 60 — not a CRO fee and not an insurance premium.

Insurance documentation is usually in the ethics committee / IRB 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

If the master cannot produce a certificate in time for the ethics calendar, you do not have paper. If local admitted paper is slower than the CEC date, say so before you book the meeting. bioaccess® sequences the packet. The carrier prints the exhibit.

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

1. Regulatory-fit, not tourism. Do not delay the certificate until after SIV. SIV is late. Ethics is early. bioaccess® still runs trials in Colombia — INVIMA-side ethics wants the same class of exhibit.
2. Protocol, IB, ICF, and the ethics committee / IRB submission with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 is the ethics-committee certificate as a start-up gate.

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 EC/IRB insurance certificate to start, start as the operator: contact bioaccess® or book from First-in-Human CRO. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country. Operator: First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

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. For comparison, the rules in the main markets are below.

This page doesn’t set out Uruguay’s own insurance rule. Confirm it with the reviewing ethics committee and a licensed local broker before relying on this page.

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 Uruguay clinical trial coverage, buy trial insurance Uruguay device FIH, Uruguay trial liability, 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.

Uruguay is one of the countries where bioaccess® runs studies. That is enough to answer the search. Confirm current ethics and coverage rules with qualified advisers. bioaccess® is not the carrier.

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: Uruguay insurance exhibit. 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/Uruguayan ethics / national file packet, 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.

Public geography is not a rate card

See Clinical Trials in Uruguay and the countries hub. ANMAT and ANVISA have separate pages. If Uruguay is on the protocol, the liability exhibit still needs territory, period, named insureds, and a language the committee can file — the same operator logic as the hub, not a copy of Clinical Trial Insurance in Latin America.

Do not skip Colombia because someone Googled Uruguay

A Uruguay search is not a withdrawal from Colombia. bioaccess® runs first-in-human studies in Colombia now. We pick the country the device needs. A Uruguayan certificate does not replace an INVIMA exhibit. A site page is not this page.

What ethics and Uruguayan ethics / national file actually ask for

Use the live Uruguay country page. Ask the reviewing ethics body and a licensed broker what certificate they will stamp.

Insurance documentation is usually in the ethics / Uruguayan ethics / national file packet, 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

If the carrier’s master excludes Uruguay, say so before you freeze the country list. If local admitted paper is required, a manuscript certificate may fail. Get it in writing. Introduction is not a quote. No signed carrier partnership on this page.

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

1. Regulatory-fit, not tourism. Uruguay sits on the same public LATAM map as Panama, Chile, and Colombia. Insurance territory has to match the protocol, not a 115-country brochure.
2. Protocol, IB, ICF, and the ethics / Uruguayan ethics / national file packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 Uruguay 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 Uruguay clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Uruguay operator: Clinical Trials in Uruguay. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

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:

• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 Costa Rica clinical trial coverage, CONIS trial insurance, Ley 9234 clinical trial liability, 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.

Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews first; then CONIS / the Ministry of Health registers the study. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. A 3% CONIS canon on the study budget is a legal charge, not a CRO fee, and not an insurance premium. We do not underwrite.

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: Costa Rica CONIS / Ley 9234 insurance exhibit. 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/CONIS / Ministry of Health packet, 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.

The 3% canon is not trial liability

Founders mix the CONIS budget canon with “coverage.” They are different objects. The canon is a legal charge of 3% of the study budget (Ley 9234, art. 60). Subject-injury paper is a carrier form. Paying the canon does not indemnify the participant. Filing a carrier certificate does not pay the canon. bioaccess® explains both. We sell neither.

CEC first, CONIS second, certificate in the stack

An NCT location row is not CONIS registration. A hallway conversation at a Costa Rican clinic is not that registration. ICIMED, CIMCA, and other Costa Rica site pages are campuses — not insurers. Named-insured and Spanish-language asks still belong to the carrier and the clerk.

What ethics and CONIS / Ministry of Health actually ask for

Use Clinical Trials in Costa Rica. Costa Rica’s biomedical-research stack sits under Ley N.° 9234. An accredited CEC reviews the protocol first; then the study is registered with CONIS / the Ministry of Health. Combined ethics + regulatory clocks on the live country page are typically ~30–90 days. Confirm the current calendar with qualified advisers; an NCT location row is not CONIS registration. A 3% CONIS canon on the study budget is a legal charge under Ley 9234, art. 60 — not a CRO fee and not an insurance premium.

Insurance documentation is usually in the ethics / CONIS / Ministry of Health packet, 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A master that excludes Costa Rica fails CONIS-side filing. A Costa Rica-only local policy that cannot add Colombia later is a trap if the protocol expands. bioaccess® still runs trials in Colombia.

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

1. Regulatory-fit, not tourism. We pick the country the device needs. Costa Rica is on the public countries hub. It is not a reason to skip INVIMA when Colombia is the indication.
2. Protocol, IB, ICF, and the ethics / CONIS / Ministry of Health packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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 Costa Rica CONIS / Ley 9234 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 Costa Rica clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Costa Rica operator: Clinical Trials in Costa Rica. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not insurance, legal, or regulatory advice. Confirm current CNEIS, SRS, 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:

• El Salvador: the CNEIS manual (2018) asks for the sponsor’s participant policy, specifying how it applies in El Salvador. The trial regulator, the Superintendencia de Regulación Sanitaria (SRS), checks at inspection whether trials hold policies “de acuerdo con regulación vigente” (SRS GCP inspection guide, 2025, item 4.1.8). The guide doesn’t say which regulation it means, and neither document sets a policy term or a minimum amount.

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 El Salvador clinical trial coverage, CNEIS trial insurance, buy FIH liability El Salvador, 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.

El Salvador is one of the countries where bioaccess® runs studies. Public case-study copy already names El Salvador as a study-conduct country. None of that makes bioaccess® a carrier. CNEIS-side ethics still wants paper.

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: El Salvador CNEIS/SRS insurance exhibit. 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, CNEIS and SRS 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.

Use the live El Salvador hub, not a new clock

See Clinical Trials in El Salvador and CRO in El Salvador. The insurance hub covers the CNEIS and SRS insurance checks. Neither the CNEIS manual nor the SRS inspection guide sets a policy term; agree it with the committee.

Public FIH copy is not a rate card

Public case-study copy describes placing a $10M clinical-trial insurance policy as a workstream in a multi-country first-in-human program. That is coordination, not underwriting, not a SKU, not a number we resell here. Other public copy covers regulatory/ethics approvals in El Salvador and Panama — still not a binder.

What CNEIS and the SRS actually ask for

Use the live El Salvador country page. Confirm current requirements with CNEIS, the SRS and a licensed broker.

Insurance documentation is usually in the CNEIS and SRS 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A master that excludes El Salvador fails the packet. A Salvadoran local policy that cannot later add Panama or Colombia is a protocol constraint. bioaccess® still runs trials in Colombia. We pick the country the device needs.

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

1. Regulatory-fit, not tourism. El Salvador is not a site page. Cediul and The Panama Clinic are not covered on this page.
2. Protocol, IB, ICF, and the CNEIS and SRS submission with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics timing in Panama and Colombia follows 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 El Salvador CNEIS/SRS 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 El Salvador clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. El Salvador operator: Clinical Trials in El Salvador. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

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. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 how startups buy trial liability before first site, bind clinical trial insurance before site selection FIH, 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.

Boards ask for insurance before they approve a country. Ethics asks for a named site on the certificate. Those two clocks fight. The move is not to skip paper. The move is a binder or a specimen with territory and a named-insured endorsement path, then a certificate once the site exists. bioaccess® sequences that. We do not sell the binder.

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: binding paper before site selection. 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-committee and national authority 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.

Do not wait for SIV to start the insurance workstream

The live hub already said: start insurance with protocol development, not after the protocol is frozen. This page is the startup version. You may not have a PI yet. You may still be choosing Panama versus Colombia. You still need a carrier who will write investigational-device trial liability in those countries. Specimen wording, territory, period, and additional-insured mechanics can be negotiated before the MSA. The named site goes on when the site is real.

Do not buy a site to unlock a policy

Picking an NCT campus because “they have insurance” is the wrong object. See site pages — they are not carriers. Do not sign a hospital MSA to inherit institutional coverage. Do not let a broker delay the quote until after first-patient. Country first (the device’s country), specimen second, site third, certificate fourth, SIV fifth.

What ethics committees and the national authority actually ask for

Use live hubs to pick geography first: Panama, Colombia, Chile, Mexico, Brazil. Then ask the carrier whether they can certificate that country. bioaccess® still runs trials in Colombia.

Insurance documentation is usually in the ethics-committee and national authority 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A startup can live on a master with certificates as countries and sites appear — if the carrier will actually issue them. A local-only policy in the wrong first country is wasted premium. 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

1. Regulatory-fit, not tourism. Regulatory-fit, not tourism. One campus is not a reason to bind the wrong territory.
2. Protocol, IB, ICF, and the ethics-committee and national authority submission with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 is binding paper before site selection.

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 how startups buy trial liability before the first site, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling who-writes: who writes FIH liability. Operator: First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

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. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 device FIH subject injury coverage LATAM, participant injury insurance investigational device, subject injury clinical trial Latin America, 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.

Subject injury is the sentence ethics actually cares about: who pays medical costs if the investigational device hurts the participant. That is not third-party premises liability. That is not the hospital’s malpractice. That is not product liability for a marketed widget. It is a trial form. bioaccess® does not write it.

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: subject-injury (participant) coverage for an investigational device. 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-committee and national device authority 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.

What subject-injury language has to survive

A device FIH can include a procedure, an implant, a follow-up window, and explant or revision if the protocol requires it. The form has to follow the IB, not a drug-trial template. Medical expenses for trial-related events, sometimes beyond the participant’s social security or private health cover, are the usual ask. Committees set thresholds. Confirm with the reviewing body and a licensed broker.

What subject-injury is not

It is not the site’s institutional policy. It is not the PI’s malpractice. It is not a U.S. GL policy with a silent OUS exclusion. It is not “we’re a Delaware C-corp so we self-insure” unless ethics accepted a financial guarantee in writing. Public case-study copy mentions a $10M clinical-trial insurance policy as a CRO-coordinated workstream. That is not a SKU. That is not underwriting.

What ethics committees and the national device authority actually ask for

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. Use CRO in Colombia. Colombia ethics timing depends on each committee’s meeting schedule. Published comparison already on the Panama country page: per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email is not INVIMA clearance.

Insurance documentation is usually in the ethics-committee and national device authority 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

Subject-injury can sit on a local admitted policy or on a master with a local certificate. The object has to name the country and the protocol period. A 115-country brochure does not treat a participant in Panama.

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

1. Regulatory-fit, not tourism. If the protocol adds Colombia, the exhibit has to name Colombia. bioaccess® still runs trials there.
2. Protocol, IB, ICF, and the ethics-committee and national device authority submission with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 is subject-injury (participant) coverage for an investigational device.

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 device FIH subject-injury coverage in Latin America, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: international device trial liability. Hub: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

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. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 ISO trial policy vs local admitted, Crowe clinical trial insurance, ISO form clinical trial liability LATAM, 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.

Founders search “ISO trial policy” and “Crowe” because a broker slide used those words. ISO here is an insurance-manuscript problem, not ISO 14155. Crowe is a name people type for international placement. Neither is a bioaccess® product. We do not name a signed broker or carrier partnership on this page. We run the trial. A licensed broker places paper. A carrier binds it.

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: manuscript/ISO-style international form versus local admitted exhibit. 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-committee and national authority 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.

ISO 14155 is the quality system. ISO-style paper is a different object

bioaccess® device protocols run under ISO 14155. That is monitoring, TMF, SAE, and the 21 CFR 812.28 narrative. It is not a liability form. An “ISO” trial policy in broker slang is usually a manuscript written on an international program. Local admitted paper is what some Latin American clerks will actually stamp. Do not mix the acronyms on a board slide.

Admitted vs manuscript is not master vs local

The local-vs-controlled-master page has its own page. This page is the form language: a non-admitted or freedom-to-contract manuscript versus a locally admitted policy in the country of the ethics committee. Some countries will file a certificate from a manuscript. Some will not. Ask the clerk and the broker.

What ethics committees and the national authority actually ask for

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance. Use Clinical Trials in Brazil. In Brazil a CEP reviews ethics under Lei 14.874/2024 and ANVISA reviews device trials under RDC 837/2023. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Trial authorization and later market registration are separate workstreams.

Insurance documentation is usually in the ethics-committee and national authority 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

If the committee wants admitted local paper, a foreign manuscript without a local certificate is a resubmission. If the committee will file a certificate from a master, do not buy a second local policy just because a slide said “admitted.” Get the requirement in writing. bioaccess® can introduce a specialty carrier or broker. Introduction is not a quote and not a partnership announcement.

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

1. Regulatory-fit, not tourism. Paper has to follow the protocol’s countries, including Colombia if Colombia is on the map. bioaccess® still runs trials in Colombia.
2. Protocol, IB, ICF, and the ethics-committee and national authority submission with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 is manuscript/ISO-style international form versus local admitted 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 ISO-style trial policy vs local admitted paper, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related page: local vs controlled master.

Julio G. Martinez-Clark, CEO · bioaccess®

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. Recent rule changes and the primary-law rules that matter most for this topic:

• Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
• Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
• Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
• Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.

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 investigator vs sponsor policy OUS, PI malpractice clinical trial insurance, investigator indemnification FIH, 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.

Investigators have malpractice. Sponsors need trial-liability. Ethics wants the sponsor form, often with the PI named as additional insured. Filing the PI’s malpractice certificate as if it were the trial form is how you lose a calendar month. This is not the site-MSA page. That page is hospital institutional coverage. This page is the investigator’s own policy.

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: investigator malpractice versus sponsor trial form. 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-committee and national authority 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.

What malpractice is built to do

Malpractice covers the clinician’s professional acts in ordinary care. It is not written for an investigational device that has never been in a human, a protocol-defined follow-up window, or a Delaware sponsor who imported the product. Some policies explicitly exclude research. Read the exclusion. Do not improvise a workaround with the PI.

What the sponsor form has to add for the PI

Additional-insured status when the committee requires it. Indemnity in the clinical trial agreement that matches the policy. A claims-notice path that can sit next to the SAE clock. Territory that names the country. The CRO coordinates that stack. The carrier issues the endorsement. bioaccess® does not underwrite the PI and does not sell a PI rider.

What ethics committees and the national authority actually ask for

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. 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-committee and national authority 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

Do not let a master “cover investigators” in a brochure replace the additional-insured endorsement the clerk asked for. Do not let the PI’s local malpractice replace the sponsor form. Both objects can exist. One does not eat the other.

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

1. Regulatory-fit, not tourism. Going direct to a PI to “use their insurance” is how you confirm interest and still fail ethics. Contract the CRO. Introduce a carrier for the sponsor form.
2. Protocol, IB, ICF, and the ethics-committee and national authority submission with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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 is investigator malpractice versus sponsor trial form.

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 investigator vs sponsor policy for OUS FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related page: site vs sponsor policy.

Julio G. Martinez-Clark, CEO · bioaccess®

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:

• Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.

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 Panama clinical trial insurance FIH, CNBI trial liability, buy trial coverage Panama device, 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.

Panama ethics typically 3–5 weeks; with bioaccess® coordination, protocol to first-patient averages 6–8 weeks on the live hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. Those are start-up and visit-cost figures, not premiums. CNBI-registered ethics still wants paper in the packet.

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: Panama MINSA/CNBI insurance exhibit. 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/MINSA / CNBI packet, 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.

Early-feasibility in Panama is ethics-committee-driven

Live Panama blogs already say early-feasibility is ethics-committee-driven — not an INVIMA/ANVISA-style second national device step. Insurance documentation gaps are a common resubmission on the insurance hub. This page does not repeat that hub. It answers “Panama FIH insurance” so a founder does not treat bioaccess® as the carrier.

The Panama Clinic and other campuses are not insurers

Cediul is not covered on this page. The Panama Clinic is not this page. A hallway conversation at a Panama hospital is not MINSA clearance and it is not a binder. Named-insured requests for the PI and site are common. A U.S. certificate in English only is a delay. Ask for Spanish when the committee asks for Spanish.

What ethics and MINSA / CNBI actually ask for

Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

Insurance documentation is usually in the ethics / MINSA / CNBI packet, 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A master that cannot issue a Panama certificate is decoration. A Panama-only local policy that cannot later add Colombia is a one-country trap if the protocol expands. bioaccess® still runs trials in Colombia. We pick the country the device needs.

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

1. Regulatory-fit, not tourism. Panama is often a first FIH country on this platform. Insurance is in the same stack as import and ISO 14155 — not a founder WhatsApp after SIV is booked.
2. Protocol, IB, ICF, and the ethics / MINSA / CNBI packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 Panama MINSA/CNBI 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 Panama FIH trial insurance, start as the operator: contact bioaccess® or book from First-in-Human CRO. Panama operator page: Clinical Trials in Panama. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

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:

• Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.

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 Peru DIGEMID clinical trial coverage, INS trial insurance Peru device, buy trial liability Lima, 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.

INS (under DS 021-2017-SA) authorizes trials. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. None of those three objects is a liability binder. We do not underwrite.

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: INS / DIGEMID Peruvian insurance exhibit. 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/INS / DIGEMID packet, 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.

Do not confuse DIGEMID import with trial liability

A published statutory target on the Peru hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. The hub already cites experience-based cost on the order of ~30% lower versus the US — that is a country-page figure, not a campus quote and not a premium.

Lima and Arequipa sites are not carriers

Goyeneche Arequipa, Rebagliati, Clínica Internacional, and other Peru site pages are campuses. INEN Lima has its own page and is not an insurance exhibit. A hallway conversation in Lima is not INS clearance and it is not a binder.

What ethics and INS / DIGEMID actually ask for

Use Clinical Trials in Peru. INS (under DS 021-2017-SA) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru country page cites experience-based costs about ~30% lower than in the US.

Insurance documentation is usually in the ethics / INS / DIGEMID packet, 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. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A U.S. master that excludes Peru fails ethics. A Peruvian local policy that cannot add Colombia later is a protocol constraint. Tell the CRO before you freeze the country list. bioaccess® still runs trials in Colombia.

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

1. Regulatory-fit, not tourism. We pick the country the device needs. Peru is not Panama. A DIGEMID import permit is not a trial-liability form. See importer of record for clinical trial devices in Latin America.
2. Protocol, IB, ICF, and the ethics / INS / DIGEMID packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. 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. Ethics review in both Panama and Colombia runs 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 INS / DIGEMID Peruvian 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 Peru DIGEMID trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Peru operator page: Clinical Trials in Peru. Sibling: Goyeneche is a site, not a policy.

Julio G. Martinez-Clark, CEO · bioaccess®