cms.bioaccessla.com

Category: First-in-Human

  • Leonardo Rodríguez Grunert, MD: Chile FIH Site Contact Is Not the CRO

    Names and roles cited from ClinicalTrials.gov study records NCT02709577, NCT05887635, and NCT06724822 (OverallOfficial and location-contact fields). Registry rows are not a bioaccess® claim that we ran these studies. Dual Clínica Colonial / Clínica MEDS La Dehesa affiliation is an operator fact confirmed by bioaccess® leadership on 24 September 2026; it is not a ClinicalTrials.gov MEDS PI or CONTACT row. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, boards, or a MEDS NCT investigator string.

    If you searched Leonardo Rodriguez Grunert MD first-in-human, Leonardo Rodríguez Grunert Chile clinical trial, Dr Rodriguez Colonial Chile CRO, Leonardo Rodriguez MEDS La Dehesa, EndoBarrier Chile PI, duodenal RF vapor ablation Chile investigator, or “go direct Leonardo Rodriguez Grunert,” you followed named investigator / site-contact strings ClinicalTrials.gov publishes. Public registry strings include Leonardo Rodriguez Grunert, MD and Leonardo Rodriguez, MD — the same person; this page uses Grunert in the title and notes the ClinicalTrials.gov alias. The public posture visible on those rows is digestive / metabolic / endoscopic device investigation. A named principal investigator or site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact or OverallOfficial field is not a CRO.

    This page answers the Rodríguez Grunert search. Matching facility pages: Clínica Colonial Santiago and Clínica MEDS La Dehesa Santiago. Dual affiliation (Clínica Colonial and Clínica MEDS La Dehesa) is confirmed as an operator fact. Colonial / Hospital Dipreca roles come from ClinicalTrials.gov only. We do not invent a Clínica MEDS La Dehesa NCT PI or CONTACT row — none appears on the public MEDS location contacts cited for that campus today.

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

    Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

    • Name: Leonardo Rodríguez Grunert, MD (ClinicalTrials.gov also lists Leonardo Rodriguez, MD).
    • NCT02709577 — COMPLETED DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Leonardo Rodriguez Grunert, MD” / Hospital Dipreca (GI Sleeve / EndoBarrier type 2 diabetes program on the public brief title).
    • NCT05887635 — RECRUITING DEVICE row; location CONTACT “Leonardo Rodriguez, MD” / Clinica Colonial, Santiago, Chile (duodenal mucosal RF vapor ablation).
    • NCT06724822 — ACTIVE_NOT_RECRUITING DEVICE row; OverallOfficial PRINCIPAL_INVESTIGATOR “Leonardo Rodriguez, MD” / Clinica Colonial, Santiago, Chile (RF vapor retreatment).
    • Affiliations on this page: Clínica Colonial (Santiago) from the public NCT rows above; Clínica MEDS La Dehesa as dual affiliation per operator confirmation — not as an invented MEDS NCT PI string.

    We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent specialty board certifications. Emailing a named contact confirms interest. It does not open ISP.

    The contact is the contact. The CRO is the operator.

    What a named PI or site contact can typically do when a sponsor “goes direct”:

    • Discuss clinical interest and whether a protocol fits their digestive / metabolic / endoscopic device service line.
    • Point toward institutional ethics calendars and campus research rules at Colonial or MEDS when they practice there.
    • Help estimate local visit and procedure effort for cases they will run.

    What a named contact is not built to own for an investigational device:

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile pages already put a typical ISP review in a band of about 30 business days. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation with a named MD is not that stack.
    • Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
    • Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
    • Multi-country optionality if the indication later needs another Latin American country.

    Going direct to an MD name on ClinicalTrials.gov is how you find a person. It is not how you open an investigational file.

    How ISP actually works (the short version)

    Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

    Ask for a protocol-specific calendar. A PI email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site-contact 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 investigator

    Leonardo Rodríguez Grunert, MD, is a named public NCT principal investigator and site contact on serious DEVICE rows spanning Hospital Dipreca and Clínica Colonial. Dual practice at Clínica MEDS La Dehesa is an operator fact, not a smear. That is evidence of a person on Santiago campuses, not a punchline. Hire the operator. Activate a campus only if it fits.

    Colombia is still on the map

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I email Leonardo Rodríguez Grunert, MD directly for a device FIH?

    You can try using whatever contact channel the public registry exposes. A named PI or site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your ISP 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 NCT02709577, NCT05887635, or NCT06724822?

    No. We cite the public OverallOfficial and location-contact roles as identity evidence. We will not invent a sponsor claim. We will not claim bioaccess® ran these studies.

    Is Rodríguez Grunert only Clínica Colonial?

    ClinicalTrials.gov cites Hospital Dipreca (NCT02709577 OverallOfficial) and Clínica Colonial (NCT05887635 CONTACT; NCT06724822 OverallOfficial). Dual affiliation with Clínica MEDS La Dehesa is an operator fact confirmed 24 September 2026. We do not invent a MEDS NCT PI or CONTACT row on this page.

    Is this the same page as Clínica Colonial or Clínica MEDS La Dehesa?

    No. Those are facility pages. This is the named PI / site-contact page. These three pages are distinct: Clínica Colonial Santiago, Clínica MEDS La Dehesa Santiago, and this page.

    Next step

    If the search that brought you here was this MD name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility siblings: Clínica Colonial Santiago and Clínica MEDS La Dehesa Santiago.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Clínica MEDS La Dehesa Santiago: The NCT Campus String Is Not the ISP File

    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 ISP, 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 MEDS La Dehesa Santiago as a bioaccess® client.

    If you searched Clinica MEDS La Dehesa Santiago first-in-human, MEDS La Dehesa Clinic clinical trial, Clinica MEDS Dehesa CRO, MEDS La Dehesa Chile CRO, or “go direct Clínica MEDS La Dehesa Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Clínica MEDS La Dehesa SpA in Santiago, Chile, is a real named clinic-campus string on ClinicalTrials.gov (aliases include Clinica MEDS La Dehesa SpA; brand framing also appears as MEDS / MEDS La Dehesa Clinic). It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns ISP, 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 Santiago Clínica MEDS La Dehesa campus. It is DISTINCT from Clínica Alemana de Santiago, Clínica Santa María Santiago, Clínica Colonial Santiago, and Hospital Luis Tisné Santiago. Sharing Santiago metro is not a license to collapse them. Clínica MEDS La Dehesa is not Clínica Alemana. Clínica MEDS La Dehesa is not Clínica Colonial. Clínica MEDS La Dehesa is not Clínica Santa María.

    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.

    Brand or slide marketing that mentions “more than 30 clinical trials underway” is marketing copy — not a ClinicalTrials.gov count and not used as a registry figure on this page.

    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 Clínica MEDS La Dehesa Santiago first-in-human finds ALL n=3 (DEVICE n=3) without finding ISP. A named clinic campus is still a site. An NCT location row is not a CRO. A sports-medicine brand story is still 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:

    • ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Clínica MEDS La Dehesa is not a Clínica Alemana file, not a Clínica Colonial file, and not a Clínica Santa María 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 ISP actually works (the short version)

    Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

    Ask for a protocol-specific calendar. A hospital email is not ISP 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 MEDS La Dehesa Santiago is a serious named Chilean campus on the public registry — Chile’s first high-complexity sports-medicine clinic brand (surgery, inpatient, and outpatient lines across many specialties) is a real operator story, not a punchline. ALL n=3 and DEVICE n=3 are registry volume. Do not replace registry counts with slide marketing. 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 ISP / 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Clínica MEDS La Dehesa Santiago 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 ISP 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 Clínica Alemana de Santiago or Clínica Colonial Santiago?

    No. Clínica Alemana de Santiago and Clínica Colonial Santiago are distinct Santiago campuses. This page is Clínica MEDS La Dehesa / Clinica MEDS La Dehesa SpA only.

    Does “more than 30 clinical trials underway” mean ALL n=30 on ClinicalTrials.gov?

    No. That figure is brand/slide marketing. This page cites the ClinicalTrials.gov facility string only: ALL interventional n=3; DEVICE n=3 (NCT06073457, NCT06613724, NCT07431723). We will not invent a larger registry count.

    Did bioaccess® run NCT06073457, NCT06613724, or NCT07431723?

    No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies.

    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. Santiago sibling (do not merge): Clínica Alemana de Santiago.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Virgilio B. Castillero D, DDS: Panama FIH Site Contact Is Not the CRO

    Names and roles cited from ClinicalTrials.gov study NCT05374993 location-contact fields (LastUpdatePostDate 2026-09-22 location add). Registry contact rows are not a bioaccess® claim that we opened a new NCT action in this window. General information, not legal or regulatory advice. Confirm current MINSA, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, metrics, or an El Salvador hospital string.

    If you searched Virgilio B. Castillero D DDS first-in-human, Virgilio Castillero Panama clinical trial, Dr Castillero Interamericana Panama CRO, Castillero Zero3 Panama, or “go direct Virgilio Castillero,” you followed a named site-contact string ClinicalTrials.gov publishes on the Universidad Interamericana de Panamá location block for NCT05374993. Virgilio B. Castillero D, DDS, is a named location CONTACT on that public DEVICE_FEASIBILITY row (TriAgenics Inc; Zero3 System). A named site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the MINSA file.

    bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns MINSA, CNBI-registered ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact field is not a CRO.

    This page answers the Castillero search. The matching facility page is Universidad Interamericana de Panamá (Panama City). Co-listed site contact on the same NCT location block: Aristides Joel Castillo Vásquez, DDS. Study director on the registry: Leigh Colby, DDS (TriAgenics Inc). Castillero and Castillo are kept separate. We do not invent titles beyond the public CONTACT role. We do not invent an El Salvador hospital.

    A public bioaccess® TriAgenics case study already describes a Zero3 FIH program framed across Panama and El Salvador. That case study is not a Castillero PI kill page.

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

    Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

    • Name: Virgilio B. Castillero D, DDS — NCT location CONTACT on Universidad Interamericana de Panamá for NCT05374993.
    • Facility: Universidad Interamericana de Panamá, Panama City, Panama.
    • Device / sponsor: Zero3 System / TriAgenics Inc; DEVICE_FEASIBILITY; planned enrollment 35; status NOT_YET_RECRUITING on the cited public row.

    We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent enrollment progress. Emailing a named contact confirms interest. It does not open MINSA.

    The contact is the contact. The CRO is the operator.

    What a named site contact can typically do when a sponsor “goes direct”:

    • Discuss clinical interest and whether a protocol fits their service line.
    • Point toward institutional ethics calendars and campus research rules.
    • Help estimate local visit and procedure effort for cases they will run.

    What a named contact is not built to own for an investigational device:

    • MINSA national file and CNBI-registered ethics packet as the applicant/operator stack.
    • Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
    • Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
    • Multi-country optionality if the indication later needs another Latin American country.

    Going direct to a DDS name on ClinicalTrials.gov is how you find a person. It is not how you open an investigational file.

    How MINSA actually works (the short version)

    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 contact email is not MINSA clearance.

    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 investigator

    Virgilio B. Castillero D, DDS, is a named public NCT site contact on a serious DEVICE_FEASIBILITY row. That is evidence of a person on a campus, not a punchline. Hire the operator. Activate the campus only if it fits.

    Colombia is still on the map

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I email Virgilio B. Castillero D, DDS directly for a device FIH?

    You can try using whatever contact channel the public registry exposes. A named site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your MINSA 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 NCT05374993?

    This page does not invent a new NCT-action claim for this window. See the public TriAgenics case study for the published Zero3 FIH program story. That page is not this PI kill page.

    Is Castillero the same page as Castillo or Universidad Interamericana?

    No. Aristides Joel Castillo Vásquez, DDS, is a separate co-listed NCT location CONTACT. Universidad Interamericana de Panamá is the facility page. The three pages are distinct.

    Should I invent an El Salvador hospital because the case study mentions El Salvador?

    No. NCT05374993 lists Universidad Interamericana de Panamá in Panama. We do not invent an El Salvador hospital string on this page.

    Next step

    If the search that brought you here was this DDS name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Universidad Interamericana de Panamá site page (same NCT). Related case study (not this kill page): TriAgenics case study.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Aristides Joel Castillo Vásquez, DDS: Panama FIH Site Contact Is Not the CRO

    Names and roles cited from ClinicalTrials.gov study NCT05374993 location-contact fields (LastUpdatePostDate 2026-09-22 location add). Registry contact rows are not a bioaccess® claim that we opened a new NCT action in this window. General information, not legal or regulatory advice. Confirm current MINSA, ethics, and FDA rules with qualified advisers. We do not invent emails, phones, metrics, or an El Salvador hospital string.

    If you searched Aristides Joel Castillo Vásquez DDS first-in-human, Aristides Castillo Panama clinical trial, Dr Castillo Interamericana Panama CRO, Castillo Zero3 Panama, or “go direct Aristides Joel Castillo Vásquez,” you followed a named site-contact string ClinicalTrials.gov publishes on the Universidad Interamericana de Panamá location block for NCT05374993. Aristides Joel Castillo Vásquez, DDS, is a named location CONTACT on that public DEVICE_FEASIBILITY row (TriAgenics Inc; Zero3 System). A named site contact is not a first-in-human medical-device CRO, and a personal reply is not the operator of the MINSA file.

    bioaccess®’s position is simple and it is not adversarial: the investigator / site contact is part of the site. The First-in-Human CRO still owns MINSA, CNBI-registered ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Sponsors who skip the CRO and email a named NCT contact still have to rebuild that stack. An NCT contact field is not a CRO.

    This page answers the Castillo search. The matching facility page is Universidad Interamericana de Panamá (Panama City). Co-listed site contact on the same NCT location block: Virgilio B. Castillero D, DDS. Study director on the registry: Leigh Colby, DDS (TriAgenics Inc). Castillo and Castillero are kept separate. We do not invent titles beyond the public CONTACT role. We do not invent an El Salvador hospital.

    A public bioaccess® TriAgenics case study already describes a Zero3 FIH program framed across Panama and El Salvador. That case study is not a Castillo PI kill page.

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

    Registries often surface investigator and site-contact names next to a facility. Sponsors searching those names land on people, not operators. Public facts we cite:

    • Name: Aristides Joel Castillo Vásquez, DDS — NCT location CONTACT on Universidad Interamericana de Panamá for NCT05374993.
    • Facility: Universidad Interamericana de Panamá, Panama City, Panama.
    • Device / sponsor: Zero3 System / TriAgenics Inc; DEVICE_FEASIBILITY; planned enrollment 35; status NOT_YET_RECRUITING on the cited public row.

    We cite those public fields only. We do not reprint personal email or phone from the NCT onto this page. We do not invent enrollment progress. Emailing a named contact confirms interest. It does not open MINSA.

    The contact is the contact. The CRO is the operator.

    What a named site contact can typically do when a sponsor “goes direct”:

    • Discuss clinical interest and whether a protocol fits their service line.
    • Point toward institutional ethics calendars and campus research rules.
    • Help estimate local visit and procedure effort for cases they will run.

    What a named contact is not built to own for an investigational device:

    • MINSA national file and CNBI-registered ethics packet as the applicant/operator stack.
    • Investigational import end-to-end (see importer of record for clinical trial devices in Latin America).
    • Clinical trial insurance, ISO 14155 monitoring, EDC, SAE reporting, TMF, and the 21 CFR 812.28 package.
    • Multi-country optionality if the indication later needs another Latin American country.

    Going direct to a DDS name on ClinicalTrials.gov is how you find a person. It is not how you open an investigational file.

    How MINSA actually works (the short version)

    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 contact email is not MINSA clearance.

    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 investigator

    Aristides Joel Castillo Vásquez, DDS, is a named public NCT site contact on a serious DEVICE_FEASIBILITY row. That is evidence of a person on a campus, not a punchline. Hire the operator. Activate the campus only if it fits.

    Colombia is still on the map

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I email Aristides Joel Castillo Vásquez, DDS directly for a device FIH?

    You can try using whatever contact channel the public registry exposes. A named site contact can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your MINSA 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 NCT05374993?

    This page does not invent a new NCT-action claim for this window. See the public TriAgenics case study for the published Zero3 FIH program story. That page is not this PI kill page.

    Is Castillo the same page as Castillero or Universidad Interamericana?

    No. Virgilio B. Castillero D, DDS, is a separate co-listed NCT location CONTACT. Universidad Interamericana de Panamá is the facility page. The three pages are distinct.

    Should I invent an El Salvador hospital because the case study mentions El Salvador?

    No. NCT05374993 lists Universidad Interamericana de Panamá in Panama. We do not invent an El Salvador hospital string on this page.

    Next step

    If the search that brought you here was this DDS name, start as the operator: contact bioaccess® or book from First-in-Human CRO. Facility sibling: Universidad Interamericana de Panamá site page (same NCT). Related case study (not this kill page): TriAgenics case study.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Universidad Interamericana de Panamá: The NCT Campus String Is Not the MINSA File

    Figures cited from ClinicalTrials.gov study NCT05374993 (LastUpdatePostDate 2026-09-22 location add; status NOT_YET_RECRUITING as of that public row) and published bioaccess® country pages. Registry location rows are not a bioaccess® claim that we opened a new NCT action in this window. General information, not legal or regulatory advice. Confirm current MINSA, ethics, and FDA rules with qualified advisers. We name only the facility string and site-contact names those public NCT fields support. We do not invent an El Salvador hospital string (none appears on this NCT). We do not invent emails or metrics.

    If you searched Universidad Interamericana de Panamá first-in-human, Universidad Interamericana Panama clinical trial, Interamericana Panama CRO, TriAgenics Zero3 Panama site, Universidad Interamericana de Panama NCT05374993, or “go direct Universidad Interamericana de Panamá,” you followed a campus string ClinicalTrials.gov now publishes on NCT05374993. Universidad Interamericana de Panamá in Panama City, Panama, is a real named university-campus string on that DEVICE_FEASIBILITY row (TriAgenics Inc; Zero3 System; planned enrollment 35). It is not a first-in-human medical-device CRO, and it is not the operator of the MINSA file.

    bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns MINSA, CNBI-registered 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 campus or the named site contacts still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Panama City Universidad Interamericana de Panamá campus for the public Zero3 / TriAgenics location string. It is DISTINCT from Hospital Punta Pacífica Panama City, Hospital Paitilla Panama City, The Panama Clinic, and CEVAXIN. Sharing Panama City is not a license to collapse them. Universidad Interamericana de Panamá is not Hospital Punta Pacífica. Universidad Interamericana de Panamá is not Hospital Paitilla. Universidad Interamericana de Panamá is not The Panama Clinic.

    A separate public bioaccess® TriAgenics case study already describes a Zero3 first-in-human program framed across Panama and El Salvador. That page is a case study. It is not a Universidad Interamericana site page, and it is not a license to invent an El Salvador hospital string on this page — ClinicalTrials.gov does not list an El Salvador facility on NCT05374993. This draft cites the Panama location row only.

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

    Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On the public NCT05374993 row (LastUpdatePostDate 2026-09-22 location add), this campus sits here:

    • Universidad Interamericana de Panamá (Panama City, Panama) — public NCT location string on NCT05374993 (DEVICE_FEASIBILITY; Zero3 System; TriAgenics Inc; planned enrollment 35; overall status NOT_YET_RECRUITING on that public row). Named site contacts on the same location block (public NCT fields): Aristides Joel Castillo Vásquez, DDS; Virgilio B. Castillero D, DDS. Study director on the registry: Leigh Colby, DDS (TriAgenics Inc).

    This page uses only that single location row and those named NCT contact fields. We do not invent ALL/DEVICE ranks for this campus — the 1 September 2026 LATAM facility sweep does not carry this string as a multi-study campus.

    That NCT ID is how a sponsor searching the university name, the Zero3 System, or the named DDS contacts lands on a campus without landing on an operator. We cite it as facility evidence. We will not invent additional principal investigators. We will not invent enrollment, clock, or cost metrics beyond what published bioaccess® Panama pages already state for the country stack.

    That is the leak: a founder searching Universidad Interamericana de Panamá first-in-human, TriAgenics Panama, or Zero3 Panama site finds a DEVICE_FEASIBILITY location row without finding MINSA. A named university campus is still a site. An NCT location row is not a CRO.

    What the public NCT actually says (facts only)

    Public brief title: a first-in-human study of a novel 3rd molar tooth bud ablation procedure. Intervention type DEVICE; intervention name Zero3 System; lead sponsor TriAgenics Inc. Design on the public row: single-arm prospective, non-randomized; phases N/A; planned enrollment 35. Eligibility ages on the public row: 8 to 12 years. Primary outcome measure on the public row: incidence of wound healing and adverse events (90 days). Status on the cited pull: NOT_YET_RECRUITING. We will not invent timing, enrollment progress, or site activation claims beyond that public status.

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

    A named university campus 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 campus 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 research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

    • MINSA. MINSA is the national file for an investigational device in Panama. CNBI-registered ethics still has to sit. A hallway conversation on this campus is not that stack. Early-feasibility on the live Panama blogs is ethics-committee-driven — not an INVIMA/ANVISA-style second national device step. We will not invent a new Panamanian clock on this page. A hallway conversation at Universidad Interamericana de Panamá is not a Hospital Paitilla file and is not The Panama Clinic file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a site-contact 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-campus MSA will not stretch. The public TriAgenics case study already frames a two-country program story; this page still does not invent an El Salvador hospital string absent from NCT05374993.

    Going direct to this campus — or emailing the DDS names ClinicalTrials.gov lists as location contacts — is how you confirm a room. It is not how you open an investigational file.

    How MINSA actually works (the short version)

    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 university is not MINSA clearance.

    Ask for a protocol-specific calendar. A campus email is not MINSA 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 campus

    Universidad Interamericana de Panamá is a serious named Panamanian campus on the public registry for NCT05374993. A DEVICE_FEASIBILITY location row is registry evidence, not a punchline. Name the NCT site contacts as public fields. We do not invent additional investigators. 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 MINSA / 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Universidad Interamericana de Panamá directly for a device FIH?

    You can try. The campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by appearing on ClinicalTrials.gov, become your MINSA 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 NCT05374993?

    This page does not invent a new NCT-action claim for this window. A public bioaccess® TriAgenics / Zero3 case study already describes FIH work framed across Panama and El Salvador. That case study is not this facility kill page. We cite NCT05374993’s Panama location row as facility evidence for Universidad Interamericana de Panamá. We do not invent an El Salvador hospital string absent from that NCT.

    Is this the same page as the TriAgenics case study?

    No. bioaccessla.com/case-studies/triagenics is the public case study. This page is the Universidad Interamericana de Panamá site page for the NCT05374993 location string.

    Is this the same page as Hospital Paitilla or The Panama Clinic?

    No. Hospital Paitilla is a distinct Panama City campus. The Panama Clinic has its own page and must not be republished here. This page is Universidad Interamericana de Panamá only.

    Who are Aristides Joel Castillo Vásquez, DDS and Virgilio B. Castillero D, DDS on this page?

    They are the named site contacts ClinicalTrials.gov publishes on the Universidad Interamericana de Panamá location block for NCT05374993. We cite those public name fields. We do not invent titles beyond what the NCT prints. Emailing a named site contact is still not a CRO.

    Should I invent an El Salvador hospital because the TriAgenics case study mentions El Salvador?

    No. NCT05374993’s public locations list Universidad Interamericana de Panamá in Panama City, Panama. This page stays on that row.

    Next step

    If the search that brought you here was this campus, the Zero3 System, or the named NCT site contacts, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related public case study (not this kill page): TriAgenics case study. Distinct Panama City siblings (do not merge): Hospital Punta Pacífica Panama City, Hospital Paitilla Panama City.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Chile ISP clinical trial path for medical devices: investigation vs Exempt Decree No. 25 registro

    Sponsors mix two Chile clocks into one bar labeled “ISP.” One clock is Instituto de Salud Pública (ISP) authorization for a medical-device clinical investigation and investigational import. The other is commercial sanitary registration under Chile’s expanding Exempt Decree No. 25 wave. They are not the same petition. Confusing them is how a Santiago FIH plan quietly becomes a 2028 market-access scramble.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the operator brief for running a medical-device clinical trial in Chile under ISP — and keeping that trial file off the commercial registro track. It is grounded in the live FIH startup clock, fast-track FIH corridor, Chile Exempt Decree No. 25 / ISP registration 2028, and Chile site posts such as Hospital Luis Tisné Santiago. It is not a quote and not legal advice. Confirm current ISP, ethics, and import instructions before you file.

    Two Chile files — write them apart first

    1. Investigation file (this page). ISP authorizes the clinical investigation and investigational-device import. An Ethical-Scientific Committee under Law 20.120 still has to sit. Success criterion: authorized research use of the named investigational article at named sites.
    2. Commercial registro file (different Gantt). Exempt Decree No. 25 (published 19 March 2026) expands mandatory ISP sanitary registration across 39 product types, including software as a medical device and multiple IVDs, with transition waves toward 2028/2029. Success criterion: conformity verification / ISP sanitary registration for manufacture, import, marketing, or distribution of covered products after the applicable transition dates.

    Live Chile blogs already put a typical ISP investigation review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file. Do not put both on one Gantt labeled “Chile.”

    Where Chile sits on the FIH map

    Chile is inside Latin America’s fast-track FIH corridor with Panama, El Salvador, and Costa Rica. In our recent plans, ethics and regulatory approval of a complete submission in these countries took about 1 to 3 months, and site activation from protocol synopsis to first patient about 8 to 9 months (see our site activation timeline guide). In Panama, the ethics-submission ID arrives in about 3 business days. Chile’s published role in that corridor is different: corridor speed plus top-tier perceived data rigor — the combination sponsors look for when they do not want a “small fast market” discount on the evidence package.

    Speed drivers on the live corridor page: efficient ethics and ISP pathways; experienced committees. Cost tier: upper among corridor countries — you pay for depth and perception. Population is still small; feasibility and backup sites matter.

    What ISP owns on the trial track

    • Clinical-investigation authorization. ISP is the investigation desk for device studies in Chile. A named hospital campus on ClinicalTrials.gov is not the ISP applicant and is not the operator of the ISP file.
    • Investigational-device import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See the regional investigational import guide.
    • Not commercial registro. Post-Decree 25 market access (technical instruction from ISP within up to 12 months of publication, Spanish IFU/label expectations, tecnovigilancia enrollment) belongs on the commercial track. Keep it off the FIH critical path until first patient is locked.

    We will not invent PAHO/WHO Level 4 standing for ISP. All bioaccess® device protocols in this country run under ISO 14155 and the Declaration of Helsinki.

    The legal basis, in one paragraph

    ISP’s power over the trial file comes from Código Sanitario Article 111 A, added by Ley 20.850 in 2015. It requires an “autorización especial para uso provisional con fines de investigación” for drugs and medical devices used in research on humans, when the product has no sanitary registration or will be used differently from its registration. The sponsor files after the accredited Comité Ético Científico (CEC) approval required by Ley 20.120. The authorization lasts up to one year and can be renewed. Exempt Decree No. 25 is a separate instrument. It adds 39 device and in vitro diagnostic (IVD) types to mandatory ISP registration for manufacture, import, sale and distribution: 13 types by 19 March 2028 and 26 by 19 March 2029. It does not mention clinical investigation. For how the device route compares with drug trials inside ISP, see why Chile’s ISP regulates device trials differently from drug trials.

    Ethics under Law 20.120

    An Ethical-Scientific Committee under Law 20.120 still has to sit. Institutional ethics calendars at Chilean hospitals are real — and they are not ISP. Share committee calendars and hospital research rules with the CRO early. Do not wait for the ISP letter to discover that the committee meets monthly and your Spanish informed-consent text is still in draft.

    Operator rule: same protocol version and same Spanish informed-consent text across the ethics packet and the ISP packet. The commercial IFU you will later lock under Decree 25 is not the ethics ICF.

    Submission checklist (investigation dossier)

    Assemble the universal FIH core once, then layer Chile. We do not invent form codes that are not on live bioaccessla.com pages — use this operator checklist against ISP’s current published requirements at filing time.

    Section What to freeze Operator check
    Protocol Version, endpoints, stopping rules Same version for ISP and Ethical-Scientific Committee
    Investigator’s brochure / preclinical Risk profile for first human use Matches the article on the investigational device list
    Informed consent (Spanish) Ethics-ready castellano Not the commercial IFU for Decree 25 registro
    Insurance Trial-related injury coverage Territory names Chile; language matches ethics packet
    ISO 14155 monitoring plan GCP bridge for foreign data Design for 21 CFR § 812.28 inspectability if a U.S. file is intended
    Investigational labeling For clinical investigation only Lot/serial traceability matches site accountability
    Device / accessory list Every unit in the accountability log Quantities match what import will request
    Importer of record Legal name before ethics stamps Document ties shipment to investigation authorization — not a commercial ISP certificate
    Ethics letter (Law 20.120) Ethical-Scientific Committee outcome Keep correspondence in one trial master file
    ISP investigation authorization Study authorization + import path ~30 business-day planning band; confirm at filing

    Import: investigational units are not the Decree 25 SKU

    Name the trial importer before ethics stamps the protocol. Map every investigational model, accessory, and spare to the investigation-authorized list. Outer labels must read as investigational. After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy.

    Hand-carry is not the plan. Formal, traceable importation tied to the trial authorization is required across Latin America; Chile is not an exception.

    If the Chile FIH must support a U.S. file

    Design the investigation so the evidence room can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States): GCP, independent ethics review, and a device comparable to the version you will put in front of FDA. ISO 14155 is the device GCP bridge. A clean ISP investigation letter does not replace an inspectable trial master file. Eligibility of foreign data under § 812.28 is not a clearance prediction. See the live 812.28 LATAM inspectability page.

    Not a critique of the hospital — and do not skip ISP

    Named Santiago campuses on ClinicalTrials.gov (for example Hospital Luis Tisné, Clínica Colonial) are real hospital strings. They can discuss investigator interest, local visit costs, and ethics calendars. They cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR § 812.28 packager. The First-in-Human CRO still owns those workstreams — plus the option to add another Latin American country if one Chilean campus is not the only enrollment fit.

    Common rejection / delay patterns

    • One “ISP” bar for trial and registro. Investigation (~30 business days planning) versus commercial registration (30–90 days planning; Decree 25 waves later) are different files.
    • Commercial certificate on investigational freight. Decree 25 / sanitary registration paperwork does not clear FIH kits.
    • Hospital NCT string treated as the regulatory plan. Campus ≠ ISP file.
    • Importer named after first patient. Import then becomes the critical path.
    • Waiting for ISP’s Decree 25 technical instruction before any commercial readiness. That is a market-access problem — keep it off the FIH critical path, but do not ignore it for launch planning.

    One-page gate before first patient in Chile

    • Authority map: ISP investigation + Ethical-Scientific Committee (Law 20.120) versus commercial ISP registro under Exempt Decree No. 25 only if launch is truly in scope.
    • Same protocol version and same Spanish informed-consent text across ethics and ISP packages.
    • Investigational importer named, with the document that ties the shipment to the investigation authorization.
    • Device list complete, including accessories.
    • ISO 14155 file owner who can produce monitoring, accountability, and ethics letters within 48 hours if FDA asks.
    • Feasibility: real site-level patient flow for your indication — corridor speed does not create patients.

    Frequently asked questions

    Does Exempt Decree No. 25 change how medical device clinical trials are authorized in Chile?

    No. Exempt Decree No. 25 (published 19 March 2026) makes ISP sanitary registration mandatory for 39 listed device and IVD types before they are manufactured, imported, sold or distributed in Chile. It does not mention clinical investigations. Research use is governed by Código Sanitario Article 111 A.

    When do the Decree 25 registration deadlines apply?

    The decree counts from publication in the Diario Oficial on 19 March 2026: 24 months for 13 listed types (19 March 2028) and 36 months for the other 26 (19 March 2029). ISP must issue the technical instruction within 12 months of publication.

    Does an investigational device need a Chilean registro sanitario?

    No. Article 111 A requires an ISP special authorization for provisional use for research when a device has no sanitary registration, or will be used differently from its registration. That authorization, not a registro, is the trial permit.

    Which regulation says ISP authorizes device trials?

    Código Sanitario Article 111 A, added by Ley 20.850 in 2015, covers both pharmaceutical products and medical devices used in research on humans. Decreto Supremo (DS) 114 Article 7, often cited for ISP trial authorization, refers to medicines.

    How many device types needed ISP registration before Decree 25?

    ISP’s registration page lists the products already under mandatory registration: latex gloves, condoms, sterile hypodermic needles and syringes, portable automated external defibrillators, HIV in vitro diagnostic (IVD) tests, immunohematology reagents and IVD reagents for screening blood donations. Decree 25 adds 39 types in two waves.

    General information, not legal advice. Verify current requirements with ISP and your CEC before filing.

    Related reading on bioaccessla.com

    Planning a Chile FIH file — ISP investigation, Law 20.120 ethics, and investigational import kept off the Decree 25 registro track? Talk with bioaccess® — contact Julio Martinez-Clark at jmclark@bioaccessla.com or +1 (954) 903-7210.

  • How to obtain ANVISA, COFEPRIS, ANMAT, or Panama MINSA approval for a medical device clinical trial

    Sponsors keep asking one stacked question: how do I obtain ANVISA, COFEPRIS, ANMAT, or Panama MINSA approval for a medical device clinical trial? Those four names are not interchangeable stamps. Each one is a different investigation desk, with a different ethics gate, and a different investigational-import story. Treating them as one “LATAM approval” is how a Gantt goes soft.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is a comparison hub for medical-device clinical-investigation authorization in Brazil, Mexico, Argentina, and Panama. It is grounded in live bioaccessla.com posts on the FIH startup clock, investigational import, ANMAT investigation checklist, Mexico’s COFEPRIS reset, and the Panama / El Salvador corridor pages. It is not a quote and not legal advice. Confirm every instrument against each agency’s current published texts before you file.

    Write four columns before translators start

    Put these four tracks on one page. Do not merge them into a single “regulatory” bar.

    1. Brazil — ANVISA. Agency review of the device clinical investigation, plus ethics (CEP/CONEP), plus a two-layer import path.
    2. Mexico — COFEPRIS. Federal protocol authorization, plus CONBIOÉTICA-linked ethics, plus a research-use import permit.
    3. Argentina — ANMAT. Investigation authorization (not commercial registro), plus independent ethics, plus provincial filings where required.
    4. Panama — MINSA. Ministry of Health investigation track with CNBI-registered ethics — the documented sprinter in the fast corridor.

    If the board slide says “we got LATAM approval,” ask which desk, which ethics letter, and which import document.

    Same question, four different clocks

    Published operator planning bands on the live startup clock (confirm at contracting):

    Country / desk Planning activation band Why the band looks that way
    Panama — MINSA + CNBI ethics About 1 to 3 months from complete submission to approval in our recent plans (fast corridor); activation follows import and site readiness Ethics-submission ID in about 3 business days on published experience; parallel ethics and regulator work
    Mexico — COFEPRIS + ethics Historically 6–9 months; watchlist with asterisk Published reset language cuts protocol review toward ~30 days with ethics running in parallel on each committee’s meeting schedule — verify measured clocks before you put Mexico in the fast corridor by default
    Brazil — ANVISA + CEP/CONEP 6–9 months Full agency review plus ethics; largest patient pool in the region
    Argentina — ANMAT + ethics 6–9 months Investigation desk with a 90-business-day statutory review target that pauses for RFIs; FIH/EFS often exceeds the target

    Panama sits with Chile, El Salvador, and Costa Rica in the fast corridor, where approval of a complete submission took about 1 to 3 months in our recent plans; see our site activation timeline guide for the full path to first patient. Mexico, Brazil, Colombia, and Argentina sit in the major-market band unless a measured clock proves otherwise.

    Brazil — ANVISA (investigation + import are two layers)

    For investigational devices, Brazil is a two-layer system on the live import guide:

    • ANVISA clinical-investigation approval under RDC 837/2023. The Comunicado Especial lists the investigational products and authorized quantities.
    • Licença de Importação (LI) in Siscomex with ANVISA release at the port. The import rulebook (RDC 81/2008) is under revision — confirm the current instrument before citing it at filing.

    Ethics runs through CEP/CONEP. Portuguese certificate-of-insurance language is not optional stationery for that packet. Use the Brazil clinical-trials hub for clocks; do not invent medians here.

    Operator check: freeze the investigational product list once. The Comunicado Especial quantities must match what Siscomex will see. A commercial sanitary registration number does not clear FIH freight.

    Mexico — COFEPRIS (reset language ≠ measured clock yet)

    COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is Mexico’s federal health regulator. CONBIOÉTICA is the national bioethics commission. Live COFEPRIS reset coverage already states:

    • Published direction cuts clinical-trial protocol review from ~120 days toward ~30 days.
    • An abbreviated pathway in force since 1 September 2025 gives ~30-business-day device decisions for products already authorized by certain reference regulators.
    • A 15 January 2026 decree amended the Ley General de Salud on clinical-research reform, with COFEPRIS–CONBIOÉTICA coordination.
    • Regulatory reliance language recognizes evaluations by FDA, EMA, MHRA, and Health Canada for clinical-research protocols.
    • Ethics / IRB review remains a separate clock, timed to each committee’s meeting schedule.

    Import: a research-use import permit connected to the COFEPRIS trial authorization. Confirm the current COFEPRIS procedure at filing — agency processes have been changing.

    Until sponsors and CROs have measured real-world clocks across several submissions, keep Mexico on the watchlist with an asterisk. Parallelize ethics and regulator filings; do not bank the announcement as Panama-class speed.

    Argentina — ANMAT (investigation is not registro)

    ANMAT is one agency name on two files. Write them apart before anyone translates:

    1. Investigation file. Clinical-investigation authorization for FIH or early feasibility, plus independent ethics under ISO 14155 and the Declaration of Helsinki, plus provincial oversight where required (for example Buenos Aires). Device clinical studies fall under Disposición ANMAT 969/1997, the regime for medical technology clinical studies; its Article 3 sets a 90-business-day statutory review target that pauses for RFIs.
    2. Registro file. Sanitary registration for Classes I–IV under Disposición ANMAT N° 64/2025, including HELENA declaración jurada routes for eligible CE-marked Class I/II. Success criterion: a selling license — not a trial letter.

    Import authorization links to the ANMAT trial approval through a licensed importer of record. Argentina’s import documentation is exacting. Reconcile every document before filing. A HELENA DDJJ or a cousin SKU’s registro does not move investigational kits.

    Full dossier checklist: see the live ANMAT clinical-trial submission checklist.

    Panama — MINSA (fast corridor, still two files)

    Panama’s Ministry of Health (MINSA) oversees clinical investigations through the Dirección Nacional de Farmacia y Drogas on the live Panama hub language. Ethics review runs through institutional bioethics committees registered with the national CNBI. Published ethics band: about 3–5 weeks. Insurance exhibits belong in that packet.

    Published Class III FIH geography language points at Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 on the Panama Class III FIH guide — confirm those instruments at filing. Dollarized economy, English-capable sites, investigation units only.

    Import authorization is tied to the MINSA trial authorization. Panama’s fast startup clock only holds if import runs in parallel with ethics and regulatory submissions. Commercial registro stays a separate MINSA market-access file.

    Universal dossier core (assemble once)

    Use the same core across all four desks, then layer country packets. Grounded in the live LATAM FIH submission-package checklist:

    Section Freeze once Country layer
    Protocol Version, endpoints, stopping rules Same version across agency + ethics packs
    Investigator’s brochure / preclinical Risk profile for first human use Matches the article on the investigational list
    Informed consent Local language for ethics Spanish (MX/AR/PA) or Portuguese (BR) — not the later commercial IFU
    Insurance Trial-related injury coverage Territory and named parties match the sites
    ISO 14155 monitoring plan GCP bridge for foreign data Design for 21 CFR § 812.28 inspectability if a U.S. file is intended
    Investigational labeling + device list Lot/serial accountability Quantities match what import will request (BR: Comunicado Especial)
    Importer of record Legal name before ethics stamps Document ties shipment to investigation authorization

    How these approvals relate to FDA

    A clean ANVISA, COFEPRIS, ANMAT, or MINSA investigation letter does not replace an inspectable trial master file. 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. ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. Eligibility is not a clearance prediction. Keep device accountability, deviation logs, monitoring reports, and ethics correspondence in one place from day one. See the live FDA 21 CFR 812.28 LATAM inspectability and FDA acceptance of LATAM FIH data pages.

    Common failure patterns across all four

    • One LATAM Gantt bar. Panama’s corridor clock does not transfer to ANVISA or ANMAT.
    • Registro number on investigational freight. Commercial certificates do not clear FIH kits in Brazil, Mexico, Argentina, or Panama.
    • Ethics after agency. Sequential filing burns calendar the statutory targets never promised to absorb.
    • Importer named after first patient. Import then becomes the critical path ethics cannot fix.
    • Announcement clocks treated as measured clocks. Especially Mexico’s COFEPRIS reset — verify before you promise the board.

    One-page gate before first patient

    • Country shortlist with indication-level patient flow — not just the fastest desk.
    • Authority map: investigation desk + ethics (+ provincial / CONEP / CNBI as applicable) versus commercial registro on a separate track.
    • Same protocol version across every packet.
    • Importer named, with the document that ties shipment to investigation authorization.
    • Device list complete, including accessories and authorized quantities.
    • ISO 14155 file owner who can produce monitoring, accountability, and ethics letters within 48 hours if FDA asks.

    Related reading on bioaccessla.com

    Planning a multi-country FIH file across Brazil, Mexico, Argentina, or Panama? Talk with bioaccess® about sequencing investigation desks, ethics, and investigational import — contact Julio Martinez-Clark at jmclark@bioaccessla.com or +1 (954) 903-7210.

  • How to get IRB (CEI) approval for a medical device study in Colombia

    Sponsors keep asking how to get IRB approval for a medical device study in Colombia as if ethics were a single stamp that also clears INVIMA. It is not. In Colombia the ethics desk is a Comité de Ética en Investigación (CEI) approved by INVIMA, sitting at an IPS that holds a current Buenas Prácticas Clínicas (BPC) certificate. The investigation opinion and the import authorization are separate desks. Mixing them is how first patient slips a cycle.

    I am Julio Martinez-Clark, CEO of bioaccess®. This is the Colombia ethics walkthrough for medical-device studies, grounded in the live Colombia clinical-trial execution pillar, the INVIMA clinical-trial submission checklist, and the universal LATAM FIH submission package. It is not a quote and not legal advice. Confirm every form against INVIMA’s current Investigación Clínica — Dispositivos page before you file.

    What “IRB” means in Colombia

    US sponsors say IRB. In Colombia the working term is CEI — an INVIMA-approved research ethics committee. The CEI reviews the protocol, informed consent, and investigator packet under the human-subjects rules in Resolución 8430 de 1993. The CEI letter is not an INVIMA investigation opinion, and it is not a Registro Sanitario.

    Write three owners before you open a Spanish translation folder:

    1. CEI / ethics. INVIMA-approved committee; initial study evaluation on form ASS-RSA-FM169.
    2. INVIMA investigation opinion. For devices, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV), supported since 20 September 2022 by the GICASE group under Resolución 2022035262. Forms ASS-RSA-FM085 / ASS-RSA-FM172.
    3. Import of the investigational article. Exceptional importation under Decreto 4725 de 2005 Article 48(b), against a prior specialized-chamber opinion — not a commercial registro number on the airway bill.

    If your Gantt has one bar labeled “Colombia IRB,” you do not have an ethics plan. You have a hope.

    Site prerequisites the CEI will not waive

    A Colombian interventional device study needs more than a friendly PI:

    • A CEI approved by INVIMA.
    • A site (IPS) with a current BPC certificate. INVIMA issues that certificate after verifying compliance with Resolución 2378 de 2008 through inspection visits. The certificate runs five years.
    • Evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory, and sample-collection services inside the same habilitación. Contracting those services outside the habilitación adds documentation to every BPC modification.

    INVIMA’s register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca, and Montería, attached to established IPS and medical foundations. Bogotá, Medellín, and Cali remain the tier-1 clusters for most device programs. Replacing a site’s ethics committee is a formal BPC modification: a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO, and both committees. Treat CEI selection as a critical-path item, not an afterthought.

    Step-by-step: ethics before (or beside) the INVIMA file

    Colombia is not Panama’s parallel Type II + MINSA corridor. Plan CEI, INVIMA concept, and import as sequential critical-path items unless your operator has a documented reason to overlap them. The measured INVIMA average footed on the Colombia execution pillar is 5.1 months to a definitive concept (approve or reject). There is no statutory day-count for that concept. Do not paste a fast-corridor ethics band onto Bogotá.

    1. Freeze the protocol version that every desk will see. The universal FIH core already names protocol, investigator’s brochure, informed consent, case report form, insurance, and preclinical testing. Colombia’s country add-on is a procedure-risk matrix — procedural risk, not FDA-style design verification.
    2. Pick the IPS and confirm BPC + CEI status on INVIMA’s published registers before contracting. Do not discover a lapsed BPC certificate after the consent is translated.
    3. Draft Colombian informed consent for that CEI — regulatory Spanish adapted for the committee, not a U.S. IRB form with a machine translation stapled on.
    4. File the CEI package with ASS-RSA-FM169 (initial study evaluation completed by the ethics committee) and the reconciled Spanish + English pack: protocol, IB/preclinical, risk management (ISO 14971) appropriate to class, IFU and investigator training, clinical-trial insurance covering Colombian subjects, investigator CVs and GCP certificates, site budgets and contracts running in parallel so activation is not the bottleneck after the opinion lands.
    5. Keep the CEI letter and the SEDMRDIV file on the same investigation story. Stopping rules, device description, and the article you will import must match. Prototype authorization under Decreto 4725 de 2005 Article 36 is research and experimentation only — not health care use, not a commercial registro number.
    6. Only then treat import as its own authorization under Article 48(b). The CEI stamp does not clear customs.

    What the CEI packet must prove

    Packet item What it proves Common stall
    Protocol + stopping rules Same investigation the SEDMRDIV will see Version drift vs the INVIMA file
    IB / preclinical Risk profile for first human use Thin bench package, hoping ethics will “fill gaps”
    Colombian ICF Subjects informed in local regulatory language US IRB text with Spanish overlay
    Insurance Coverage for Colombian subjects Policy that does not name the territory or runoff the CEI expects
    Investigator docs Qualified team at a BPC site PI CV without current GCP evidence
    Procedure-risk matrix Colombia add-on on procedural risk Treating it as a product design-verification dump

    Timelines you can put on a board slide

    • CEI cadence — committee-specific. Confirm meeting frequency during site selection. This page does not invent a national CEI day-count.
    • INVIMA concept — measured average 5.1 months to a definitive concept; no statutory clock. Published approval and non-approval registers exist for device studies — read the non-approval register before you invent a “Colombia is unpredictable” narrative.
    • Import — after the specialized-chamber path that Article 48(b) requires. Plan it as its own bar.
    • Not law yet — the clinical-research framework bill filed in the Cámara in August 2025 would introduce tacit approval (7 calendar days common-risk / 30 high-risk, with FIH and novel implantables as high-risk). Do not put that clock in a diligence deck as if it were current INVIMA practice.

    Common mistakes that burn ethics weeks

    • Treating CEI approval as if it were the INVIMA investigation opinion or Registro Sanitario.
    • Skipping BPC / habilitación checks, then losing weeks on a BPC modification mid-startup.
    • Filing a drug Protocolos en Línea path (tariffs 4070 / 4083) for a device SEDMRDIV file — wrong desk.
    • Assuming post-trial access is mandatory in Colombia. It is not. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no statutory post-trial supply duty; see the LATAM PTA operator map.
    • One workstream for FIH evidence and later commercial registro. Article 18(k) of Decreto 4725 de 2005 is why class IIb and III evidence and registration strategy belong in the same plan — not why they share one ethics form.

    Related reading on bioaccessla.com

    Planning CEI plus INVIMA sequencing for a device study in Bogotá, Medellín, or Cali? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions, and 2–8 °C GDP cold chain across the region. Contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    How do I get IRB approval for a medical device study in Colombia?

    Engage an INVIMA-approved CEI at an IPS with a current BPC certificate, file the ethics package (including ASS-RSA-FM169), and keep that packet aligned with the separate SEDMRDIV investigation file and Article 48(b) import path. The CEI letter alone does not authorize the study or the investigational shipment.

    Is Colombia’s CEI the same as INVIMA authorization?

    No. Ethics (CEI), INVIMA investigation opinion (SEDMRDIV / GICASE), and exceptional import are three desks under Decreto 4725 de 2005, Resolución 8430 de 1993, and the BPC regime in Resolución 2378 de 2008.

    Which cities have INVIMA-approved ethics committees?

    INVIMA’s published register places approved committees in Bogotá, Medellín, Cali, Floridablanca, and Montería. Tier-1 device work usually concentrates in Bogotá, Medellín, and Cali.

    How long does Colombia ethics plus INVIMA take?

    CEI timing is committee-specific. INVIMA’s measured average to a definitive concept is 5.1 months with no statutory day-count. Plan sequential desks unless you have a documented overlap plan.

    Does every Colombian site need a BPC certificate?

    Yes in practice for institutions running interventional research under INVIMA oversight. The certificate runs five years and depends on habilitación services inside the same institution.

  • Real Hospital Português de Beneficência em Pernambuco Recife: The NCT Campus String Is Not the ANVISA File

    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 Real Hospital Português Recife as a bioaccess® client.

    If you searched Real Hospital Portugues Recife first-in-human, Beneficencia Portuguesa Pernambuco clinical trial, Hospital Real Portugues Recife CRO, or “go direct Real Hospital Português Recife,” you followed a campus string ClinicalTrials.gov still publishes. Real Hospital Português de Beneficência em Pernambuco in Recife, Brazil, is a real named hospital-campus 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 / CONEP, 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 Recife Real Hospital Português de Beneficência em Pernambuco campus only. It is DISTINCT from Beneficência Portuguesa São Paulo / Real e Benemérita Associação Portuguesa de Beneficência (already published). Sharing a Português / Beneficência name is not a license to merge Recife and São Paulo. Real Hospital Português Recife is not Beneficência Portuguesa SP. Real Hospital Português Recife is not UFPE Recife. Real Hospital Português Recife is not Hospital do Câncer de Pernambuco.

    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.

    • Real Hospital Português de Beneficência em Pernambuco (Recife, Brazil) — canonical NCT string: ALL interventional n=8; DEVICE n=3. Example NCT IDs: NCT03141216, NCT04540302, NCT06096142.

    Recife campus only.

    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 Real Hospital Português Recife first-in-human finds ALL n=8 (DEVICE n=3) without finding ANVISA. A named hospital campus 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 Real Hospital Português Recife is not a Beneficência Portuguesa São Paulo 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

    Real Hospital Português de Beneficência em Pernambuco Recife is a serious named Brazilian campus on the public registry. ALL n=8 and DEVICE n=3 are registry volume, not a punchline. 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Real Hospital Português Recife 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 Beneficência Portuguesa São Paulo?

    No. Beneficência Portuguesa / Real e Benemérita Associação Portuguesa de Beneficência São Paulo is already published — different city. This page is the Recife Pernambuco campus only.

    Did bioaccess® run NCT03141216?

    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. Recife sibling (do not merge): UFPE Recife.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Univás Pouso Alegre: The NCT Campus String Is Not the ANVISA File

    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 Univás Pouso Alegre as a bioaccess® client.

    If you searched Univas Pouso Alegre first-in-human, Universidade Vale do Sapucai clinical trial, Univas CRO, or “go direct Univás Pouso Alegre,” you followed a campus string ClinicalTrials.gov still publishes. Univás in Pouso Alegre, Brazil, is a real named university-campus 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 university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, 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 named Pouso Alegre Univás campus. It is DISTINCT from Federal University of Santa Maria, Federal University of Bahia Salvador, UFF Niterói, and UFPI / Federal University of Piaui (UFPI Fisioterapia is not covered on this page). Sharing a university / Brazil string is not a license to collapse them. Univás Pouso Alegre is not UFSM. Univás Pouso Alegre is not UFBA. Univás Pouso Alegre is not UFPI.

    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.

    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 Univás Pouso Alegre first-in-human finds ALL n=10 (DEVICE n=3) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

    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 at Univás Pouso Alegre is not a UFSM file and is not a UFPI 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

    Univás Pouso Alegre is a serious named Brazilian campus on the public registry. ALL n=10 and DEVICE n=3 are registry volume, not a punchline. 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

    Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 Univás Pouso Alegre 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 answers the search; it does not claim the studies.

    Is this the same page as Federal University of Santa Maria or Federal University of Piaui?

    No. Federal University of Santa Maria is already published. UFPI / Federal University of Piaui Fisioterapia strings are not covered on this page. This page is Univás Pouso Alegre only.

    Did bioaccess® run NCT03200938?

    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. Brazil sibling (do not merge): Federal University of Santa Maria.

    Julio G. Martinez-Clark, CEO · bioaccess®