Category: First-in-Human

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®

General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.

What the law says (verified 29 October 2026)

Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. The rule for this country, from the primary text:

• Chile: Código Sanitario art. 111 F requires holders of the investigational-use authorization for drugs, or for devices in the classes a decree is to set (not yet issued), to carry civil liability insurance; art. 111 E makes them liable even for unforeseeable damage, presumes causation once damage is shown and sets a ten-year limitation period from when the damage manifests. Art. 111 A makes the policy part of the ISP application. On our reading, art. 111 F makes the policy a legally required insurance, which would bring it within DFL 251 art. 4 (insurance required by law may only be bought from insurers established in Chile). We found no CMF or ISP ruling on the point, and Hospital Clínico Universidad de Chile asks industry sponsors to name their representative in Chile rather than a Chilean insurer. The opposite reading is also arguable, because the policy’s terms await a regulation that hasn’t been issued, so confirm with a Chilean broker. Separately, the regulation of Ley 20.120 (DS 114/2010, art. 25, as amended by DS 30/2012) requires every protocol for scientific research in human beings under that law to set out the insurance and guarantees that apply to foreseeable and unforeseeable adverse events. We found no published Ministry regulation or device-class decree under art. 111 F as of 29 October 2026.

Ethics-committee practice (committee rules, not law): the accredited Chilean committees whose rules we read on 29 October 2026 all ask for the policy for clinical trials, several name device trials expressly, and none sets a minimum amount. CEC Salud UC requires cover through formal closure and the last follow-up (statement, March 2025). Universidad de Chile’s CEISH asks for “la póliza y certificado de seguro” for drug and device trials (Reglamento, Res. Exenta 697 of 30 October 2024). For industry-sponsored studies, Hospital Clínico Universidad de Chile asks you to name the Chilean representative and the policy period (requirements, March 2026). Hospital del Trabajador asks for a “póliza de seguro según normativa del ISP” for drug or implant trials (committee page). Universidad Mayor asks for a Spanish-language policy for the trial in Chile, plus separate cover if investigator malpractice is excluded (committee page). The full list, with Clínica Alemana–UDD and Clínica Las Condes, is in the hub guide.

None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.

If you searched Chile ISP clinical trial insurance, buy trial coverage Chile device FIH, ISP liability policy, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.

ISP authorizes studies and investigational-device import. An Ethical-Scientific Committee under Law 20.120 still has to sit. That committee will ask who pays if the investigational device injures the participant. The answer is a carrier form, not a CRO invoice.

This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: the insurance exhibit for ISP and Chilean ethics review. Same operator: the CRO runs the trial; a carrier writes the paper.

The CRO is not the carrier

Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:

• Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
• Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
• CRO. Protocol, IB, ICF, ethics and ISP submission, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.

Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.

ISP trial authorization is not commercial registro, and neither is a binder

None of the Chilean rules we read sets an insurance minimum. Some committees ask for a Spanish-language summary.

Santiago, Temuco, Antofagasta campuses are not insurers

Dermacross, Calvo Mackenna, Estudios Reumatológicos, Vanguardia Temuco, and Psicomed Antofagasta pages on this blog are sites. Do not email them for a binder. Institutional coverage is not sponsor trial-liability. See the site insurance versus sponsor policy page if that is the search — this page is Chile ISP.

What ethics and ISP actually ask for

Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. ISP trial authorization and commercial registration are different files — do not put them on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit.

Insurance documentation is usually in the ethics and ISP submission, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):

• Territory that names every country on the protocol.
• Site and principal investigator as additional insureds when the committee requires it.
• Policy period through last-patient last-visit plus the protocol follow-up window.
• Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
• Claims-notice language that can sit next to the SAE clock, not against it.

None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. The Chilean ethics-committee rules we read don’t set an amount either. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

A master that excludes Chile is useless. A Chilean local policy that cannot later add Colombia is a one-country trap. Ask the carrier which certificate they will issue for Law 20.120 ethics, in Spanish, with the PI named. Introduction is not a quote.

A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.

What bioaccess® still owns after you have a quote

1. Regulatory-fit, not tourism. Chile is not a substitute for Colombia or Panama. We pick the country the device needs. bioaccess® still runs trials in Colombia.
2. Protocol, IB, ICF, and the ethics and ISP 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 covers the ISP / Chilean ethics insurance exhibit.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Next step

If the search that brought you here was Chile ISP clinical trial insurance, start as the operator: contact bioaccess® or book from First-in-Human CRO. Chile operator page: Clinical Trials in Chile. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

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:

• 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).

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 Argentina ANMAT clinical trial liability, buy trial insurance Argentina device FIH, ANMAT trial coverage, 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.

Argentina is a real device-trial geography. ANMAT trial authorization is a petition. Commercial registro is a different petition. Neither petition is a liability binder. bioaccess® files the operator stack. A carrier writes the 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: ANMAT / Argentine ethics 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/ANMAT 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 put trial authorization and registro on one insurance Gantt

A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs. That is a start-up clock, not a premium. Ethics still wants financial responsibility for participant injury in the packet with the protocol and ICF. A Buenos Aires hospital MSA is not that exhibit. Site pages on this blog (Favaloro, Argerich, Finochietto, Independencia Munro) are campuses, not carriers.

Spanish certificate, named PI, named site

Argentine ethics will read Spanish. They will look for the sponsor, the investigator, and the site. They will look for a period that covers follow-up. A U.S. product-liability rider that excludes OUS research is a rejection waiting for a clerk. A master that cannot issue an Argentine certificate is a slide. Ask which object you are buying. bioaccess® can introduce a specialty carrier. We do not bind ANMAT risk. We do not name a signed partnership here.

What ethics and ANMAT actually ask for

Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

Insurance documentation is usually in the ethics / ANMAT 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 local admitted Argentine policy can satisfy one committee and still fail if the protocol later adds Colombia or Panama. A master can sit behind certificates if the carrier will actually print them. For local policy versus a controlled master, see OUS FIH: Local Policy vs Controlled Master; this page is Argentina-only.

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 Argentina is the wrong first country for this device, say so early. bioaccess® still runs trials in Colombia and the rest of the platform. Insurance territory has to match that map.
2. Protocol, IB, ICF, and the ethics / ANMAT 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 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 ANMAT / Argentine ethics insurance exhibit.

Can a U.S. product-liability policy cover a LATAM device FIH?

Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.

Next step

If the search that brought you here was Argentina ANMAT trial liability, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling: who writes FIH liability.

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 115-country clinical trial coverage, 115 country trial insurance device startup, multinational 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.

Some specialty carriers market multinational clinical-trial liability with a large country count. Founders type that number because a slide or an ad used it. bioaccess® does not confirm or sell that number. We are not the carrier. If your protocol is one Latin American country this year, you do not need a poster of 115 flags. You need a certificate ethics will file.

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: multinational-territory search. 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 buy a country-count. Buy the exhibit for this protocol

A device FIH in Panama, Colombia, Chile, Mexico, or Brazil is a named-territory problem. A brochure that lists a three-digit country count is marketing. It is useful only if the carrier will actually issue a local certificate for the countries on your protocol, in the right language, with the PI and site named, through follow-up. If they will not, the number is decoration.

What a startup actually needs in year one of FIH

One or two countries, ISO 14155, importer of record, an ethics packet, and paper that matches those countries. Plus a path to add a country without rebuilding the program. That path can be a master. It can be a second local policy. It is not a CRO pretending to be an insurer. It is not a hospital MSA. It is not a U.S. product-liability rider with “worldwide” in the footer and a silent OUS-research exclusion.

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 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.

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 you already have a multinational master, bring the specimen certificate to the CRO before ethics. If you do not, we can introduce a specialty carrier. Introduction is not a quote. We do not bind 115 countries. We run the trial in the countries the device needs — including Colombia, where we still run trials.

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. Country-count marketing is not a regulatory strategy. bioaccess®’s map is the Latin American FIH platform and the 21 CFR 812.28 package. See OUS FIH and FDA IDE.
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 multinational-territory search.

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 115-country trial coverage for a device startup, start as the operator: contact bioaccess® or book from First-in-Human CRO. If you still need the country-snapshot checklist, use the 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 site insurance vs sponsor policy FIH, hospital MSA insurance clinical trial, does the site cover 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.

Sites have insurance. That sentence has wrecked more start-up calendars than a slow CEP. Institutional coverage is for the hospital’s operations. Sponsor trial-liability is for the investigational protocol. Ethics wants the second object. A CRO who lets you file the first object as if it were the second is not doing the job.

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: hospital MSA coverage 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 a site policy is built to do

A named hospital can carry malpractice, premises, and sometimes clinical-research riders for its employees. That is necessary for the MSA. It is not sufficient for a first-in-human device. The participant is in a sponsor protocol. The investigational product is the sponsor’s. Import, IB, and ISO 14155 monitoring are the sponsor’s stack. When a committee asks who pays if the device injures the participant, “the hospital is insured” is not an answer unless the hospital is actually the sponsor — and on a bioaccess® FIH it is not.

What the sponsor form has to add

Additional insureds (PI and site) when the committee requires it. Territory that names the country. Period through follow-up. Language the clerk can file. Indemnity in the MSA that matches the policy — not a hospital template that dumps every investigational risk onto a Delaware C-corp with no paper behind it.

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 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-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 site MSA “include insurance” replace a master or a local trial policy. Do not let a master ignore the site’s additional-insured ask. 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 campus to “use their insurance” is how you confirm a room and still fail ethics. Contract the CRO. Let the CRO activate the site if the site fits. 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. 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 hospital MSA coverage 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 site insurance vs sponsor policy for FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. For the operator path: First-in-Human CRO. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®