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. The rule for this country, from the primary text:

• 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.

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 Mexico COFEPRIS clinical trial coverage, buy trial insurance Mexico device FIH, COFEPRIS 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 We do not quote a binder.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.

Mexico is a real FIH geography for devices. COFEPRIS reviews the protocol after ethics clearance, on a calendar we confirm per protocol. Neither review is a premium. Coverage still has to be documented: ethics committees review it, and since April 2025 COFEPRIS receives the policy or financial fund within 15 business days after it authorizes the protocol. bioaccess® is not the Mexican carrier.

This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: COFEPRIS / Mexican ethics coverage 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/COFEPRIS 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 registro sanitario with trial liability

The Mexico hub keeps trial clocks separate from registro sanitario (~30 working days on that hub). A commercial registro is not a clinical-trial form. A COFEPRIS trial authorization is not a 21 CFR 812.28 clearance. Buying “Mexico coverage” from a product-liability broker who has never seen an investigational IB is how you get a territory endorsement that still fails the committee.

Spanish certificate, named site, named PI

Mexican ethics will read Spanish. They will look for the site and the investigator. They will look for a period that covers follow-up. Guadalajara, Monterrey, Mexico City, Zapopan, and Veracruz campuses on our site pages are sites — they are not insurers. Do not email a hospital asking them to “include insurance” and call it COFEPRIS-ready. The hospital’s institutional policy is not the sponsor’s trial form.

What ethics and COFEPRIS 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.

Since the April 2025 COFEPRIS Acuerdo (art. 5), the insurance or financial fund is filed within 15 business days after protocol authorization rather than with the initial application; missing it can lead to revocation. 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 names “Mexico” in a 100-country schedule can still fail if it cannot issue a Spanish certificate for this protocol. A local Mexican policy can still fail if the protocol later adds Colombia. Ask which object you are buying. bioaccess® can introduce a specialty carrier. We do not bind COFEPRIS risk.

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. Mexico is not a substitute for Colombia or Panama. We pick the country the device needs. bioaccess® still runs trials in Colombia. A Mexican certificate does not replace an INVIMA exhibit.
2. Protocol, IB, ICF, and the ethics / COFEPRIS packet with insurance documents in the same stack — not a parallel founder email.
3. Importer of record and device accountability. A binder does not import the investigational product.
4. Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
5. Introducing a specialty carrier when the founder does not already have admitted paper. An introduction is not a partnership or a quote.

The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.

Frequently asked questions

Does bioaccess® sell clinical trial insurance?

No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind.

Is this the same article as the LATAM insurance hub?

No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page is COFEPRIS / Mexican ethics coverage 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 Mexico COFEPRIS clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Mexico operator pages: Clinical Trials in Mexico and CRO in Mexico. 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:

• 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.

Ethics-committee practice (CONEP guidance, not law): CONEP, which runs Brazil’s national ethics-review system, says in its Manual de orientação: pendências frequentes em protocolos de pesquisa clínica (version 1.0, 2015) that “O Sistema CEP/Conep não solicita a comprovação da existência de seguro para execução da pesquisa”. It treats indemnity as the duty of the sponsor, investigator and institution whether or not a policy exists. It says indemnity can’t be limited to the amount insured, and that the consent form must not tie the right to indemnity to a policy the sponsor has bought. The manual was issued in 2015 under CNS Resolution 466/2012, before Lei 14.874/2024 and its regulating Decreto 12.651/2025. Art. 39 of that decree keeps CNS ethics norms in force, where they don’t conflict with the law or the decree, until the new national ethics body issues its own; we found nothing newer that changes CONEP’s position.

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 Brazil ANVISA clinical trial liability, CONEP trial insurance, buy clinical trial coverage Brazil 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.

Brazil is a real device-trial geography. It is also a documentation geography. In Brazil the sponsor owes indemnity whether or not a policy exists (Lei 14.874/2024, arts. 23 and 26 XV). bioaccess® prepares the ethics and ANVISA file. If a policy is bought, a carrier writes the liability form.

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: ANVISA / CONEP / CEP 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 and ANVISA 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.

ANVISA is the device dossier. Indemnity is in the ethics stack

Device investigations sit under RDC 837/2023 (Portuguese dossier: IB, protocol, ICF and GMP evidence). On insurance, what CEPs check is that the consent form states the right to indemnity without tying it to a policy (CONEP manual, 2015).

Portuguese, period, and named insureds

CEP/CONEP review the consent form’s indemnity wording, not a policy. If a site contract or the sponsor’s own program requires a policy, a Portuguese translation helps the site and any local insurer, the period should run past last-patient last-visit, and the form should name the site as well as the sponsor.

What ethics and ANVISA actually ask for

Use Clinical Trials in Brazil. A CEP reviews ethics under Lei 14.874/2024 and ANVISA reviews device trials under RDC 837/2023. Trial authorization and later market registration are separate workstreams.

CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). If a site contract or another reviewer asks for a policy, 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. CONEP says indemnity can’t be capped at the amount insured. Ask the carrier and the CRO together, before the packet goes in.

Local policy vs controlled master

Under Lei 14.874/2024 the sponsor must indemnify participants; the law does not itself require a policy. Lei Complementar 126/2007, art. 19, requires cover for risks in Brazil bought by persons domiciled in Brazil to be placed in Brazil, with exceptions in art. 20. Whether that reaches your structure (for example, a foreign sponsor buying abroad) is a question for a SUSEP-licensed broker. Whatever you buy, the consent form reviewed by CEP/CONEP must not tie indemnity to it. A master that excludes Brazil, or a local policy that cannot later add Colombia, is a protocol constraint — tell the CRO before you freeze the country list.

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 Brazil is the wrong first country for this device, say so early. bioaccess® still runs trials in Colombia and other Latin American countries. Insurance territory is not a reason to pretend Brazil is Panama.
2. Protocol, IB, ICF, and the ethics and ANVISA 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 ANVISA / CONEP / CEP 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 Brazil ANVISA clinical trial liability, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil operator page: Clinical Trials in Brazil. 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:

• Colombia: Resolución 2378 de 2008 (GCP for research with medicines) lists the participant insurance policy among the documents the ethics committee reviews, and its sponsor checklist asks for contractual and extra-contractual cover sized “according to international standards”. For device studies, INVIMA’s inspection tool checks for a policy under Res. 8430/1993, art. 13. No trial rule requires a Colombian insurer, but foreign insurers may not sell cover in Colombia (EOSF art. 39).

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 Colombia INVIMA clinical trial insurance, INVIMA trial liability coverage, buy trial insurance Colombia, 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.

Colombia is still on the bioaccess® map. That is not a slogan and it is not a reason to skip the insurance exhibit. INVIMA-side ethics still wants financial responsibility for participant injury. The CRO files the packet. 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: INVIMA / Colombian 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/INVIMA 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.

What this page is not

This page does not say bioaccess® left Colombia. That story is false. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country, Miami headquarters. FOSCAL, La Sabana, Cardioinfantil, and Fundación Neumológica Colombiana pages do not flip that line. This page also does not sell a Colombian policy. We do not underwrite INVIMA risk.

What the Colombian packet actually wants

INVIMA and institutional ethics (Resolución 8430/1993 still sits on the ethics/research side) review financial responsibility as part of start-up, not as a souvenir after first patient. Expect questions about territory (Colombia named), period (through follow-up), and who is insured (sponsor, PI, site). Resolución 2378 does not govern device clinical trials — do not import a drug-GCP resolution onto a device insurance exhibit. Colombia ethics timing depends on each committee’s meeting schedule, and the live country comparison on the Panama hub still cites per-patient $15,000–$25,000 as operational cost, not as an insurance limit.

What ethics and INVIMA actually ask for

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 / INVIMA 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 Colombia is a rejection waiting for a clerk. A Colombian local policy that cannot later add Panama or Brazil is a one-country trap if the protocol expands. Ask the carrier which object they will issue for INVIMA-side ethics, in Spanish, with the site named. bioaccess® can introduce that conversation. We do not bind it.

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. If that country is Colombia, the insurance exhibit is in the same stack as the INVIMA/ethics packet, the importer-of-record file, and ISO 14155 monitoring — not a founder WhatsApp to a Bogotá hospital.
2. Protocol, IB, ICF, and the ethics / INVIMA 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 INVIMA / Colombian 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 Colombia INVIMA clinical trial insurance, start as the operator: contact bioaccess® or book from First-in-Human CRO. Colombia operator page: CRO in Colombia. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

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

What the law says (verified 29 October 2026)

Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. Recent rule changes and the primary-law rules that matter most for this topic:

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

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

If you searched OUS FIH local policy vs controlled master, local admitted clinical trial insurance vs master 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.

Boards like “one global master.” Ethics committees like a certificate they can read. Both can be true. Neither is automatic. The failure mode is a master that never issues a local exhibit, or a local policy that cannot follow the protocol into a second country.

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: local admitted paper versus master certificate. 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 “local” means in a LATAM device packet

Local, here, means the reviewing ethics committee and the national file can accept the document: language, named insureds, territory, period, and sometimes notarization. Panama CNBI, Chilean ethics committees, INVIMA-side committees and Mexican ethics committees do not share a template. (Brazil’s CEP/CONEP don’t ask for proof of insurance at all, though individual sites may.) A Miami PDF in English is a common resubmission. The CRO knows which packet the certificate sits in. The carrier issues the object. bioaccess® does not print the object.

What “controlled master” has to produce

A master is useful when the same sponsor will add countries, keep one underwriter, and issue certificates without rewriting the program. It is useless if the master excludes Latin America, excludes investigational devices, or cannot name a PI as additional insured. “Controlled” is a carrier word. Ask what certificate they will actually issue for the first country on the protocol, in the language the committee uses, with a period that covers follow-up. If the answer is a slide, you do not have paper.

What ethics committees and the national authority actually ask for

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. 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

Use both when the protocol needs both: a master for the board and the second country; a local certificate for the first ethics clerk. Do not pay twice for the same limit without asking. Do not skip the local certificate because the master “covers 100+ countries” in a brochure.

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. Start in the country the device needs. Add Colombia or Brazil only if the indication and the paper can follow. bioaccess® still runs trials in Colombia — that is operator geography, not a reason to skip INVIMA-side financial-responsibility exhibits.
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 local admitted paper versus master certificate.

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 local policy vs controlled master for OUS FIH, start as the operator: contact bioaccess® or book from First-in-Human CRO. Country clocks live on the hubs, not on a carrier brochure. Start with Panama or Colombia.

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 international clinical trial liability medical device, investigational device trial insurance OUS, 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.

Drug-trial GL language is not a device FIH form. An investigational implant, catheter, or diagnostic that has never been in a human is a different risk sentence than a marketed pill. Carriers who write “clinical trials” still have to read the IB.

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: device-specific trial liability (not drug GL). 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.

Device FIH is not a protocol footnote on a drug policy

A first-in-human medical device study asks a participant to accept an investigational product that may stay in the body, may require a procedure, and may generate SAE clocks the FDA will later read under 21 CFR 812.28. The liability form has to follow that protocol: procedure-related injury, device malfunction language, explant or revision costs if the protocol requires them, and follow-up windows that are often longer than a three-visit drug trial. The carrier reads the IB. The CRO writes the IB.

OUS is a territory problem, not a slogan

“International” on a U.S. certificate often means “we have an overseas switchboard.” Ethics in Panama, Chile, Colombia, Brazil, or Mexico wants the country named. If the protocol later adds a second Latin American country, the endorsement has to move with it. bioaccess® picks geography for the device. The paper follows the protocol. A device startup that buys a U.S.-territory clinical-trial endorsement and then opens a Colombian site has bought the wrong object.

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 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 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

For a device FIH, local admitted paper is often what the ethics clerk files. A controlled master can sit behind it if the carrier will issue certificates in the right language with the PI and site named. Do not assume a master written for a 40-site drug program will print a one-site Panama device certificate next week. Ask. Get it in writing.

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 indication later needs Colombia, Brazil, or Mexico, the operator already runs those files. The carrier has to name them. bioaccess® still runs clinical trials in Colombia.
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 device-specific trial liability (not drug GL).

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 international clinical trial liability medical device, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related device-import page: importer of record for clinical trial devices in Latin America.

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 buy international clinical trial coverage, who writes FIH clinical trial liability Latin America, HDI clinical trial insurance, 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.

Specialty carriers market multinational trial liability. Brokers place it. Hospitals photocopy a certificate. bioaccess® still has to put a device through ethics, import, and ISO 14155. Buying coverage is not starting the study.

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: who writes the paper. 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.

Why “buy coverage” searches land on a CRO

Google and LinkedIn do not separate “carrier,” “broker,” and “CRO.” A founder who has just been told “you need insurance before first patient” searches the phrase the board used. International. Clinical trial. Coverage. Liability. The ads and the blogs that answer are mixed. This page exists so that search does not treat bioaccess® as a binder. We introduce paper when the protocol needs it. We run the trial either way.

What you are actually buying

You are buying a form that ethics will file and that a later FDA reviewer can live with in the 21 CFR 812.28 package. You are not buying a CRO day-rate. You are not buying a hospital MSA. You are not buying a U.S. product-liability endorsement that silently excludes Panama, Colombia, Brazil, or Mexico. If a carrier’s marketing mentions a large country count, treat it as their marketing, not as a bioaccess® partnership.

What ethics committees and the national authority actually ask for

Use the live country hubs: Panama MINSA/CNBI on Clinical Trials in Panama; Chile ISP on Clinical Trials in Chile; Brazil ANVISA/CEP on Clinical Trials in Brazil; Mexico COFEPRIS on Clinical Trials in Mexico; Colombia INVIMA on CRO in Colombia. Ethics committees in most of these countries want the certificate in the same packet as the protocol and ICF; Mexico (COFEPRIS filing after authorization) and Brazil (CEP/CONEP don’t ask for proof of insurance) are the exceptions.

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 local admitted policy can satisfy one ethics committee and still fail a second country. A master policy written in New York or elsewhere abroad can satisfy a board slide and still fail a CNBI clerk who wants a local certificate in Spanish. (Brazil is different: CEP/CONEP don’t ask for proof of insurance, though individual sites may.) Ask which of those two objects you are buying. Then ask who files it.

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. bioaccess® still runs trials in Colombia and the rest of the Latin American platform. Insurance territory has to match that map, not a U.S.-only endorsement.
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 who writes the paper.

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 buy international clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related hub: Clinical Trial Liability Insurance in Latin America: Requirements by Country.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANMAT, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Clínica Privada Independencia Munro as a bioaccess® client.

If you searched Clinica Privada Independencia first-in-human, Independencia Munro clinical trial, Independencia CRO, or “go direct Clínica Privada Independencia Munro,” you followed a campus string ClinicalTrials.gov still publishes. Clinica Privada Independencia in Munro, Argentina, is a real named private-clinic string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ANMAT, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Munro Clínica Privada Independencia campus. It is not Sanatorio Finochietto (separate page), not Hospital Militar Cosme Argerich, not Fundación Favaloro, and not Hospital Universitario Austral Pilar. Munro is Greater Buenos Aires, not CABA. Sharing a metro is not a license to collapse them.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Clinica Privada Independencia (Munro, Argentina) — canonical NCT string: ALL interventional n=6; DEVICE n=1. Example NCT IDs: NCT05084911, NCT07472517, NCT06097260. DEVICE example: NCT07544654.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

That is the leak: a founder searching “Independencia Munro first-in-human” finds ALL n=6 (DEVICE n=1) without finding ANMAT. A named clinic is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the clinic can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the clinic is not built to own for an investigational device:

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation in Munro is not a Finochietto file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANMAT actually works (the short version)

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.

Ask for a protocol-specific calendar. A hospital email is not ANMAT clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Clínica Privada Independencia is a serious named Munro clinic on the public registry. ALL n=6 is registry volume, not a punchline. We do not invent a DEVICE n beyond 1. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANMAT / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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™.

Frequently asked questions

Can I contract Clínica Privada Independencia Munro directly for a device FIH?

You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANMAT applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this clinic. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Finochietto or Austral Pilar?

No. Sanatorio Finochietto has its own page. Hospital Universitario Austral Pilar has its own page. This page is Independencia Munro only.

Did bioaccess® run NCT05084911?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Buenos Aires sibling (do not merge): Austral Pilar.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital Lifecenter Belo Horizonte as a bioaccess® client.

If you searched Hospital Lifecenter first-in-human, Lifecenter Belo Horizonte clinical trial, Lifecenter CRO, or “go direct Hospital Lifecenter Belo Horizonte,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Lifecenter in Belo Horizonte, Brazil, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA, CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Belo Horizonte Hospital Lifecenter campus. It is not Hospital Luxemburgo, not Hospital Madre Teresa, and not UFVJM Diamantina. Sharing Minas Gerais is not a license to collapse them.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Hospital Lifecenter (Belo Horizonte, Brazil) — canonical NCT string: ALL interventional n=6; DEVICE n=0. Example NCT IDs: NCT01836575, NCT01113372, NCT01897532.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

That is the leak: a founder searching “Lifecenter Belo Horizonte first-in-human” finds ALL n=6 (DEVICE n=0) without finding ANVISA. A named hospital is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the hospital can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the hospital is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Lifecenter is not a Luxemburgo file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Hospital Lifecenter is a serious named Belo Horizonte hospital on the public registry. ALL n=6 is registry volume, not a punchline. We do not invent a DEVICE n. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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™.

Frequently asked questions

Can I contract Hospital Lifecenter Belo Horizonte directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Luxemburgo or Madre Teresa?

No. Hospital Luxemburgo has its own page. Hospital Madre Teresa has its own page. This page is Lifecenter only.

Did bioaccess® run NCT01836575?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Minas sibling (do not merge): Hospital Luxemburgo.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Instituto Jalisciense de Investigación Clínica as a bioaccess® client.

If you searched Instituto Jalisciense first-in-human, Jalisciense Investigacion Clinica Guadalajara clinical trial, Jalisciense CRO, or “go direct Instituto Jalisciense de Investigación Clínica,” you followed a campus string ClinicalTrials.gov still publishes. Instituto Jalisciense de Investigacion Clinica S.A. de C.V. in Guadalajara, Mexico, is a real named research-institute string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns COFEPRIS, ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Guadalajara Instituto Jalisciense de Investigación Clínica campus. It is not Instituto Jalisciense de Investigación en Diabetes y Obesidad (a different string, counted separately), not Endocrinológica de Jalisco, not Universidad de Guadalajara (already published), and not Investigación Biomédica Zapopan. Sharing Jalisco is not a license to collapse them.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Instituto Jalisciense de Investigacion Clinica S.A. de C.V. (Guadalajara, Mexico) — canonical NCT string: ALL interventional n=6; DEVICE n=0. Example NCT IDs: NCT04889040, NCT01987492, NCT03478930.

Counts for the Diabetes y Obesidad string are kept separate.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this institute as a client site.

That is the leak: a founder searching “Instituto Jalisciense first-in-human” finds ALL n=6 (DEVICE n=0) without finding COFEPRIS. A named institute is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named institute can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the institute can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the institute is not built to own for an investigational device:

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation on this campus is not that file. A hallway conversation at this institute is not an Endocrinológica de Jalisco file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How COFEPRIS actually works (the short version)

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.

Ask for a protocol-specific calendar. A hospital email is not COFEPRIS clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Instituto Jalisciense de Investigación Clínica is a serious named Guadalajara institute on the public registry. ALL n=6 is registry volume, not a punchline. We do not invent a DEVICE n. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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™.

Frequently asked questions

Can I contract Instituto Jalisciense de Investigación Clínica directly for a device FIH?

You can try. The institute can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this institute. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Endocrinológica de Jalisco or Zapopan?

No. Endocrinológica de Jalisco has its own page. Investigación Biomédica Zapopan has its own page. This page is Instituto Jalisciense de Investigación Clínica only.

Did bioaccess® run NCT04889040?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Jalisco sibling (do not merge): Endocrinológica de Jalisco.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital de Messejana Fortaleza as a bioaccess® client.

If you searched Hospital de Messejana first-in-human, Carlos Alberto Studart Gomes Fortaleza clinical trial, Messejana CRO, or “go direct Hospital de Messejana Fortaleza,” you followed a campus string ClinicalTrials.gov still publishes. Hospital de Messejana Dr. Carlos Alberto Studart Gomes in Fortaleza, Brazil, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANVISA, CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Fortaleza Hospital de Messejana campus. It is not the Secretaria da Saúde / Hospital Doutor Carlos Alberto Studart Gomes alias (counted separately), not Hospital Maternidade São Vicente de Paulo Barbalha, and not Hospital Agamenon Magalhães Recife. Sharing the Northeast is not a license to collapse them.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Hospital de Messejana Dr. Carlos Alberto Studart Gomes (Fortaleza, Brazil) — canonical NCT string: ALL interventional n=6; DEVICE n=0. Example NCT IDs: NCT03057977, NCT04360720, NCT04509674.

Counts for the Secretaria da Saúde alias are kept separate.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

That is the leak: a founder searching “Messejana first-in-human” finds ALL n=6 (DEVICE n=0) without finding ANVISA. A named hospital is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the hospital can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the hospital is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Messejana is not a Barbalha file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Hospital de Messejana is a serious named Fortaleza hospital on the public registry. ALL n=6 is registry volume, not a punchline. We do not invent a DEVICE n. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® still runs clinical trials in Colombia. Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. 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™.

Frequently asked questions

Can I contract Hospital de Messejana Fortaleza directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Hospital Maternidade São Vicente de Paulo Barbalha?

No. Barbalha has its own page. This page is Hospital de Messejana Fortaleza only.

Did bioaccess® run NCT03057977?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Northeast sibling (do not merge): Barbalha.

Julio G. Martinez-Clark, CEO · bioaccess®