Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® is the CRO in Peru and CRO en Perú. Headquarters in Miami. We run clinical trials there. INS and DIGEMID clocks are a file problem — not a reason to leave the country.
bioaccess® is the First-in-Human CRO for Peru: Miami headquarters and in-country operations on the INS / DIGEMID file. If you are searching CRO in Peru / CRO en Perú, this is the page that should answer. Colombia is a second country category with its own local Colombian entity — not a replacement.
bioaccess® is the CRO in Peru and CRO en Perú. Miami headquarters. We run first-in-human device studies under INS authorization and accredited ethics-committee review. That is the operating identity — not a Peruvian legal entity we do not publish, and not a country we talk sponsors out of.
The National Institute of Health (INS), through its Directorate of Health Research and Innovation (DIIS, formerly OGITT), authorizes clinical trials. DIGEMID regulates medical devices under the Ministry of Health (MINSA) and issues the investigational-device import authorization. Clocks move, stall, or come back with questions. That is a file problem for the CRO that already works the docket — not a reason to take the study out of Peru.
INS has a 40-business-day statutory target — extended to 60 business days (DS 021-2017-SA, art. 70, https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf) for biologics or cases that require technical-commission review. Those targets derive from the drug-trial framework, and novel first-in-human device studies may take longer. Eligibility of foreign data for FDA submission and review under 21 CFR 812.28 is not a guarantee of clearance or approval.
bioaccess® owns this category: Miami HQ, in-country operations, and the INS / DIGEMID file on one timeline. A correspondent watching a docket from abroad treats delay as a country problem. The CRO on the file treats delay as ethics alignment, INS responses, DIGEMID import, and site activation. That is how Global Trial Accelerators™ is meant to run.
INS (DIIS) reviews submissions under a 40-business-day statutory target — extended to 60 business days (DS 021-2017-SA, art. 70, https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf) for biologics or cases that require review by a technical commission. These windows derive from the drug-trial framework, and novel first-in-human device studies may take longer. We will not publish an invented day-count. Ask for a study-specific calendar. The country stays on the execution list.
The National Institute of Health (INS) is Peru's authority for clinical trial authorization. Its Directorate of Health Research and Innovation (DIIS, formerly OGITT) reviews submissions. Sponsors submit a Spanish protocol package. bioaccess® prepares complete INS dossiers and stays on the deficiency cycle.
Medical devices in Peru are regulated by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas) under the Ministry of Health (MINSA). DIGEMID also issues the investigational device import authorization required to ship product into Peru. A clinical-trial authorization and a commercial device registration are different files. Market-access registration pricing is quoted separately.
Every clinical study in Peru must be approved by an accredited ethics committee before enrollment can begin. Ethics review follows ISO 14155 (the FDA-recognized GCP standard for medical device investigations) and evaluates scientific merit, risk-benefit balance, informed consent, and patient protection. bioaccess® coordinates ethics submissions with partner committees. We do not operate a named Peruvian hospital.
Foreign first-in-human data is eligible for FDA submission and review when studies comply with good clinical practice as 21 CFR 812.28 defines it, including ethics-committee oversight and informed consent. bioaccess® designs Peru studies with FDA submission in mind, including electronic data capture and structured safety reporting. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Consideration | New clinical trial | DIGEMID device / import file |
|---|---|---|
| bioaccess® current recommendation | Actively executed. We run trials in Peru. | Separate file |
| Primary reason | INS clocks treated as a file problem — no new clock invented | Investigational import and commercial registration are not the trial permit |
| Regulatory instrument | INS (DIIS) clinical-trial authorization | DIGEMID under MINSA (devices + investigational import) |
| Approval clock | 40-business-day statutory target; 60 for biologics / technical commission; FIH device may exceed | Holder / subscription pricing is quoted separately |
| Where to go next | This page / CRO in Peru article | Same operating identity; two files, one kickoff |
INS has a 40-business-day statutory target (60 for biologics or technical-commission review); DIGEMID handles devices and investigational import. Novel FIH device studies may take longer than the drug-trial targets. Eligibility under 21 CFR 812.28 is not FDA clearance or approval. Market-access registration pricing is quoted separately.
bioaccess® is the CRO in Peru and CRO en Perú: Miami headquarters and in-country operations on the INS / DIGEMID file. We run clinical trials in Peru. Regulatory clocks are managed as a file problem, not used as a reason to leave.
Colombia is a second country category. bioaccess® still runs trials in Colombia with a local Colombian entity.
See the First-in-Human CRO.
Category article: CRO in Peru.
Second country: clinical trials in Colombia.
Yes. bioaccess® is the First-in-Human CRO for Peru: Miami headquarters and in-country operations on the INS / DIGEMID file. We do not publish a Peruvian legal entity on this page.
Yes. bioaccess® runs and will run clinical trials in Peru. INS and DIGEMID clocks are real. We treat them as a file problem — Spanish dossier, ethics, INS responses, DIGEMID import, site activation — not as a reason to leave the country.
The National Institute of Health (INS), through its Directorate of Health Research and Innovation (DIIS, formerly OGITT), authorizes clinical trials in Peru.
INS has a 40-business-day statutory target, extended to 60 business days for biologics or cases requiring technical-commission review (DS 021-2017-SA, art. 70). These targets derive from the drug-trial framework, and novel first-in-human device studies may take longer. Ask for a study-specific calendar.
DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), under the Ministry of Health (MINSA), is Peru's medical device regulator. DIGEMID also issues the investigational device import authorization.
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets the GCP conditions in that rule, including INS authorization and accredited ethics-committee approval. bioaccess® designs every Peru study with that FDA conversation in mind. Eligibility is not a guarantee of clearance or approval.
Actual cost depends on device complexity, indication, monitoring intensity, and sample size.
No. We contract sites. We do not claim to operate a named Peruvian hospital, and we do not publish a Peruvian legal entity on this page.
Peru is a country we run first-in-human work in. Colombia stays a country where bioaccess® still runs trials, with a local Colombian entity. Colombia has its own page.
Last reviewed: July 2026
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