General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.
What the law says (verified 29 October 2026)
Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. The rule for this country, from the primary text:
- Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.
If you searched Peru DIGEMID clinical trial coverage, INS trial insurance Peru device, buy trial liability Lima, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.
INS (under DS 021-2017-SA) authorizes trials. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. None of those three objects is a liability binder. We do not underwrite.
This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: INS / DIGEMID Peruvian insurance exhibit. Same operator: the CRO runs the trial; a carrier writes the paper.
The CRO is not the carrier
Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:
- Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
- Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
- CRO. Protocol, IB, ICF, ethics/INS / DIGEMID packet, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.
Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.
Do not confuse DIGEMID import with trial liability
A published statutory target on the Peru hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. The hub already cites experience-based cost on the order of ~30% lower versus the US — that is a country-page figure, not a campus quote and not a premium.
Lima and Arequipa sites are not carriers
Goyeneche Arequipa, Rebagliati, Clínica Internacional, and other Peru site pages are campuses. INEN Lima has its own page and is not an insurance exhibit. A hallway conversation in Lima is not INS clearance and it is not a binder.
What ethics and INS / DIGEMID actually ask for
Use Clinical Trials in Peru. INS (under DS 021-2017-SA) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru country page cites experience-based costs about ~30% lower than in the US.
Insurance documentation is usually in the ethics / INS / DIGEMID packet, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):
- Territory that names every country on the protocol.
- Site and principal investigator as additional insureds when the committee requires it.
- Policy period through last-patient last-visit plus the protocol follow-up window.
- Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
- Claims-notice language that can sit next to the SAE clock, not against it.
None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
A U.S. master that excludes Peru fails ethics. A Peruvian local policy that cannot add Colombia later is a protocol constraint. Tell the CRO before you freeze the country list. bioaccess® still runs trials in Colombia.
A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.
What bioaccess® still owns after you have a quote
- Regulatory-fit, not tourism. We pick the country the device needs. Peru is not Panama. A DIGEMID import permit is not a trial-liability form. See importer of record for clinical trial devices in Latin America.
- Protocol, IB, ICF, and the ethics / INS / DIGEMID packet with insurance documents in the same stack — not a parallel founder email.
- Importer of record and device accountability. A binder does not import the investigational product.
- Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
- Introducing a specialty carrier when the founder does not already have admitted paper. An introduction is not a partnership or a quote.
The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.
Frequently asked questions
Does bioaccess® sell clinical trial insurance?
No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind.
Is this the same article as the LATAM insurance hub?
No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page covers the INS / DIGEMID Peruvian insurance exhibit.
Can a U.S. product-liability policy cover a LATAM device FIH?
Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.
Next step
If the search that brought you here was Peru DIGEMID trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Peru operator page: Clinical Trials in Peru. Sibling: Goyeneche is a site, not a policy.
Julio G. Martinez-Clark, CEO · bioaccess®