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 Universidade Federal de Minas Gerais as a bioaccess® client.
If you searched Federal University of Minas Gerais first-in-human, UFMG Belo Horizonte clinical trial, Universidade Federal de Minas Gerais CRO, or “go direct Universidade Federal de Minas Gerais,” you followed a campus string ClinicalTrials.gov still publishes. Federal University of Minas Gerais (Universidade Federal de Minas Gerais) in Belo Horizonte, Brazil, is a real university string on ClinicalTrials.gov. It is not Hospital das Clínicas da UFMG as this page’s campus. 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 university 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 university still have to rebuild that stack. An NCT location row is not a CRO.
This page is the university NCT string. Distinct from Hospital das Clínicas da UFMG — a different NCT string family, the same way University of São Paulo is not HCFMUSP. Distinct from Santa Casa de Belo Horizonte (CMS 95660). Sharing Belo Horizonte is not a license to collapse the university into the teaching hospital or into Santa Casa. Related HC-UFMG strings may be named only to distinguish them. They are not this campus.
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; complete dump), this campus sits here after filters:
Counts come from leftover rows in /workspace/five-trials/kill-page-batch-5-picks-2026-09-01.md plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET). The CSV top-40 dump does not include these ranks. We cite the picks-file and JSONL n values. We do not invent a global CSV rank. We do not publish a unique-study union across alias strings.
- Federal University of Minas Gerais (Belo Horizonte, Brazil) — canonical English NCT string: ALL interventional n=29; DEVICE n=3. Example NCT IDs: NCT00106964, NCT01006473, NCT01006486.
- Portuguese alias Universidade Federal de Minas Gerais (same city): ALL n=17. That alias is named here so a founder searching the Portuguese spelling still lands on this slug. We do not publish a second slug. We do not add 29+17 as a unique-study union.
Cite each n separately. We will not merge Hospital das Clínicas da UFMG as this page’s campus. We will not invent a union with Santa Casa BH.
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 university as a client site.
That is the leak: a founder searching “UFMG clinical trial” or “Federal University of Minas Gerais FIH” finds ALL n=29 (DEVICE n=3; Portuguese alias ALL n=17) without finding ANVISA, CEP, import, insurance, or 21 CFR 812.28 — and without landing on Hospital das Clínicas da UFMG or Santa Casa BH. A university NCT string is still not a CRO. We will not treat the teaching-hospital string as this campus.
The site is the site. The CRO is the operator.
A named university 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 university 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 university 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 on the university string is not a Santa Casa BH file and is not Hospital das Clínicas da UFMG as this campus.
- 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-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.
Do not smear the university
Universidade Federal de Minas Gerais is a serious public university. ALL n=29 (DEVICE n=3) on the English string, and ALL n=17 on the Portuguese alias, is registry volume, not a punchline. Do not add 29+17. Do not merge Hospital das Clínicas da UFMG as this page’s campus. Do not merge Santa Casa BH (CMS 95660). Use the site when the protocol fits. Hire the operator.
What the CRO still does after you have the campus on a slide
- 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.
- Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
- Importer of record and device accountability.
- Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
- 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. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
Frequently asked questions
Can I contract Universidade Federal de Minas Gerais directly for a device FIH?
You can try. The university 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 university. We will not invent that claim. This page intercepts the search; it does not claim the studies.
Is this the same page as Hospital das Clínicas da UFMG or Santa Casa de Belo Horizonte?
No. Hospital das Clínicas da UFMG is a different NCT string family — like USP versus HCFMUSP — and is not this page’s campus. Santa Casa de Belo Horizonte is CMS 95660. This page is the Federal University of Minas Gerais / Universidade Federal de Minas Gerais university string only.
Why two ALL n values on one page?
ClinicalTrials.gov stored an English canonical string (ALL n=29; DEVICE n=3) and a Portuguese alias (ALL n=17). This page intercepts both as one university campus family. It does not add the counts.
Is n=29 plus n=17 equal to 46 unique studies?
We will not claim that. Overlap between alias rows is expected. We list each n. We do not publish a union.
Is this Hospital das Clínicas da UFMG?
No. That is a different NCT string, the same distinction as University of São Paulo versus HCFMUSP. Related strings may appear only to keep the campuses apart. This page is the university string.
Does DEVICE n=3 mean this university already owns ANVISA for a new device FIH?
No. Combined ethics + ANVISA still typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs 30 business days; per-patient $20,000–$35,000 on the Brazil hub. A DEVICE n of 3 is a registry token, not a dossier.
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. Country: clinical trials in Brazil. Belo Horizonte sibling (do not merge): Santa Casa de Belo Horizonte.
Julio G. Martinez-Clark, CEO · bioaccess®