Category: Preparing for First-In-Human Studies

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Chile’s Public Health Institute (Instituto de Salud Pública, ISP), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Universidad Católica del Maule Talca as a bioaccess® client.

If you searched Universidad Catolica del Maule Talca first-in-human, Universidad Católica del Maule clinical trial, UCM Talca device study, or “go direct Universidad Católica del Maule Talca,” you followed a campus string ClinicalTrials.gov still publishes. Universidad Católica del Maule in Talca, Chile (including the Campus San Miguel spelling on the registry), is a real named university-campus string on ClinicalTrials.gov. No separate live university-string page for this institution exists yet. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the university campus is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 campus still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Talca Universidad Católica del Maule university string. It is DISTINCT from Centro de Investigación del Maule Talca, from Hospital Clínico Universidad Católica Santiago (CMS — Hospital Clínico Universidad Católica), and from other Maule or Católica campuses. Sharing Talca or Católica is not a license to collapse them. This is the whole university string, not a lab or school subunit of a university that already has a live page.

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 a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Talca, Chile. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Universidad Católica del Maule (Talca, Chile) — registry strings counted: “Universidad Catolica del Maule”; “Universidad Católica del Maule”; “Universidad Católica del Maule – Campus San Miguel”. ALL studies n=10; interventional n=9; DEVICE n=2. Example NCT IDs: NCT02692911, NCT04251728, NCT05456282.

Aliases including Campus San Miguel are counted once per NCT ID for Talca locations; 1 of the 10 are observational.

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 campus as a client site.

That is the leak: a founder searching Universidad Católica del Maule in Talca finds ALL n=10 (DEVICE n=2) without finding ISP. 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 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 university 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 hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the university campus 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 Universidad Católica del Maule is not a Centro de Investigación del Maule file and is not an ISP 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the university

Universidad Católica del Maule is a serious named Talca campus on the public registry. ALL n=10 and DEVICE n=2 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, investigator’s brochure (IB), informed consent form (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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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 Universidad Católica del Maule Talca directly for a device FIH?

You can try. The university campus can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurance coordinator, 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 campus. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Centro de Investigación del Maule Talca?

No. Centro de Investigación del Maule Talca is a distinct Talca research-center page already published. This page is the Universidad Católica del Maule university string only.

Did bioaccess® run NCT02692911?

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. Talca sibling (do not merge): Centro de Investigación del Maule Talca.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Instituto de Cardiologia de Santa Catarina as a bioaccess® client.

If you searched Instituto de Cardiologia de Santa Catarina first-in-human, ICSC Sao Jose clinical trial, Instituto Cardiologia Santa Catarina device study, or “go direct Instituto de Cardiologia de Santa Catarina,” you followed a campus string ClinicalTrials.gov still publishes. Instituto de Cardiologia de Santa Catarina in São José, Santa Catarina, Brazil, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (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, the research ethics committee (Comitê de Ética em Pesquisa, CEP) / National Research Ethics Commission (CONEP), investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 São José Instituto de Cardiologia de Santa Catarina campus. It is DISTINCT from Instituto de Cardiologia do Rio Grande do Sul, Instituto Nacional de Cardiologia Rio de Janeiro, Instituto Nacional de Cardiología Ignacio Chávez (Mexico), and Florianópolis / Joinville campuses already published. Sharing the word Cardiologia or Santa Catarina is not a license to collapse them.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in São José, Brazil. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Instituto de Cardiologia de Santa Catarina (São José, Brazil) — registry strings counted: “Instituto de Cardiologia de Santa Catarina”. ALL studies n=12; interventional n=11; DEVICE n=1. Example NCT IDs: NCT01741558, NCT01754675, NCT02343276.

Counted once per NCT ID for São José locations; 1 of the 12 are observational.

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 Instituto de Cardiologia de Santa Catarina in São José finds ALL n=12 (DEVICE n=1) 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 ANVISA Collegiate Board Resolution (RDC) 837/2023 (dossier in Portuguese: investigator’s brochure (IB), protocol, informed consent form (ICF), insurance, good manufacturing practice (GMP) evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Instituto de Cardiologia de Santa Catarina is not an Instituto de Cardiologia do Rio Grande do Sul file and is not an ANVISA 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the hospital

Instituto de Cardiologia de Santa Catarina is a serious named São José campus on the public registry. ALL n=12 and DEVICE n=1 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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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 Instituto de Cardiologia de Santa Catarina 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, insurance coordinator, 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 Instituto de Cardiologia do Rio Grande do Sul?

No. That is a different state and a different campus string. This page is Instituto de Cardiologia de Santa Catarina in São José only.

Did bioaccess® run NCT01741558?

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 cardiology sibling (do not merge): PROCAPE Recife.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Chile’s Public Health Institute (Instituto de Salud Pública, ISP), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Hospital Dr. Hernán Henríquez Aravena Temuco as a bioaccess® client.

If you searched Hospital Hernan Henriquez Aravena Temuco first-in-human, Hospital Dr Hernán Henríquez Aravena clinical trial, Temuco hospital device study, or “go direct Hospital Dr. Hernán Henríquez Aravena Temuco,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Dr. Hernán Henríquez Aravena in Temuco, Chile, is a real named hospital-campus string on ClinicalTrials.gov, registered under several accent and abbreviation spellings. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 Temuco Hospital Dr. Hernán Henríquez Aravena campus. It is DISTINCT from Hospital Clínico Universidad de La Frontera Temuco strings, from Clínica Alemana Temuco, and from Santiago ISP-path campuses already published. Sharing Temuco or a regional health service is not a license to collapse them.

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

Device registries write the city, the facility, and a list of NCT IDs. They rarely write the CRO. On a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Temuco, Chile. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Hospital Dr. Hernán Henríquez Aravena (Temuco, Chile) — registry strings counted: “Hospital Dr Hernan Henriquez Aravena”; “Hospital Dr Hernán Henríquez Aravena”; “Hospital Dr. Hernan Henriquez Aravena”; “Hospital Dr. Hernán Henríquez Aravena”; “Hospital Hernan Henriquez Aravena”; “Hospital Hernán Henríquez Aravena”. ALL studies n=16; interventional n=11; DEVICE n=1. Example NCT IDs: NCT00412893, NCT00413218, NCT00467857.

Aliases are counted once per NCT ID for Temuco locations; 5 of the 16 are observational. We do not invent a combined Universidad de La Frontera count 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 hospital as a client site.

That is the leak: a founder searching Hospital Dr. Hernán Henríquez Aravena in Temuco finds ALL n=16 (DEVICE n=1) without finding ISP. 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:

• 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 Hospital Dr. Hernán Henríquez Aravena is not a Universidad de La Frontera file and is not an ISP 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (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 outside-the-United-States (OUS) FIH data and the FDA Investigational Device Exemption (IDE).

Not a critique of the hospital

Hospital Dr. Hernán Henríquez Aravena is a serious named Temuco campus on the public registry. ALL n=16 and DEVICE n=1 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, investigator’s brochure (IB), informed consent form (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-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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 Hospital Dr. Hernán Henríquez Aravena Temuco 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 ISP applicant, importer of record, insurance coordinator, 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 Universidad de La Frontera Temuco?

No. This page is the named Hospital Dr. Hernán Henríquez Aravena campus only. A university-string page is a different page if and when it is live.

Did bioaccess® run NCT00412893?

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. Chile sibling (do not merge): Hospital Clínico San Borja Arriarán Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov API v2 facility pull (29 September 2026) 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 rules from Mexico’s Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), the ethics committees, and the U.S. Food and Drug Administration (FDA) with qualified advisers. We name only the facility strings and example National Clinical Trial (NCT) identifiers those sources support. We do not invent a principal investigator (PI). We do not claim Western Medical Center (IMSS CMNO) Guadalajara as a bioaccess® client.

If you searched Western Medical Center IMSS Guadalajara first-in-human, Centro Medico Nacional de Occidente clinical trial, CMNO Guadalajara device study, or “go direct Western Medical Center (IMSS CMNO) Guadalajara,” you followed a campus string ClinicalTrials.gov still publishes. Western Medical Center of the Mexican Institute of Social Security (IMSS) in Guadalajara, Mexico — also registered as Centro Médico Nacional de Occidente and Centro Médico de Occidente-IMSS — is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human (FIH) medical-device contract research organization (CRO), and it is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns COFEPRIS, accredited ethics, investigational import, clinical trial insurance placement with a licensed carrier (the CRO is not the insurance carrier), ISO 14155 (the International Organization for Standardization standard for clinical investigation of medical devices) monitoring, and the FDA 21 CFR 812.28 (Title 21, Code of Federal Regulations, section 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 Guadalajara IMSS Western Medical Center / Centro Médico Nacional de Occidente campus. It is DISTINCT from Centro de Investigación Médica de Occidente in Zapopan, from Hospital Ángeles Andares Guadalajara, and from other IMSS strings in other cities. Sharing the word Occidente or Guadalajara is not a license to collapse them. The English Western Medical Center spelling and the Spanish CMNO spellings are the same Guadalajara campus counted once per NCT ID.

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 a 29 September 2026 ClinicalTrials.gov API v2 pull (all study types; all years), this campus string sits here:

Counts are unique NCT IDs returned by a ClinicalTrials.gov API v2 pull on 29 September 2026 for the facility strings listed below, restricted to locations in Guadalajara, Mexico. ALL counts every registered study type; the interventional and DEVICE counts are subsets of ALL. Alias spellings are counted once per NCT ID. We do not combine counts across separate campuses or other cities. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• Western Medical Center, Mexican Institute of Social Security (Guadalajara, Mexico) — registry strings counted: “Centro Medico Nacional de Occidente”; “Centro Medico de Occidente-IMSS”; “Centro Médico Nacional de Occidente”; “Western Medical Center, Mexican Institute of Social Security”. ALL studies n=20; interventional n=16; DEVICE n=1. Example NCT IDs: NCT00026078, NCT00129142, NCT00336791.

Aliases (Western Medical Center; Centro Médico Nacional de Occidente; Centro Médico de Occidente-IMSS) are counted once per NCT ID for Guadalajara locations; 4 of the 20 are observational.

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 Western Medical Center or Centro Médico Nacional de Occidente in Guadalajara finds ALL n=20 (DEVICE n=1) without finding COFEPRIS. 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:

• COFEPRIS. COFEPRIS governs device investigations in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. A hallway conversation on this campus is not that file. A hallway conversation at CMNO Guadalajara is not a Zapopan Occidente research-center file and is not a COFEPRIS 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. The CRO coordinates the policy with a licensed insurer; the CRO is not the insurance carrier. We will not invent a campus-only premium or rate here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (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 good clinical practice (GCP) / ethics documentation. Eligibility is not clearance, and a site master services agreement (MSA) does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

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

How COFEPRIS actually works (the short version)

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance.

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

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

Not a critique of the hospital

Western Medical Center / Centro Médico Nacional de Occidente is a serious named Guadalajara IMSS campus on the public registry. ALL n=20 and DEVICE n=1 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, investigator’s brochure (IB), informed consent form (ICF), insurance, and the COFEPRIS / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Submission (Pre-Sub), IDE, 510(k) premarket notification, De Novo request, premarket approval (PMA), or humanitarian device exemption (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 Western Medical Center (IMSS CMNO) Guadalajara 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 COFEPRIS applicant, importer of record, insurance coordinator, 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 Centro de Investigación Médica de Occidente Zapopan?

No. Centro de Investigación Médica de Occidente Zapopan is a distinct Zapopan page already published. This page is the Guadalajara IMSS Western Medical Center / CMNO campus only.

Did bioaccess® run NCT00026078?

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. Occidente sibling (do not merge): Centro de Investigación Médica de Occidente Zapopan.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. bioaccess® does not speak for Vantage. Statements about Vantage are attributed to its public website (vantage-ct.com) and its newsletter, The Vantage Brief, as of 28 September 2026. Confirm any detail that matters to your program with Vantage directly.

If you searched Vantage Clinical, Vantage Kazakhstan, or vantage-ct, you are probably weighing Kazakhstan for an early-phase clinical trial. This page does three things. It separates the Kazakhstan platform from a U.S. site network with a similar name. It summarizes what Vantage publicly says it offers. And it explains where Latin America, and bioaccess®, The First-in-Human CRO (contract research organization), fit when your program includes a medical device first-in-human (FIH) study.

First, which “Vantage”?

Two unrelated organizations show up for this search:

• Vantage Clinical (vantage-ct.com). Describes itself as sovereign-backed clinical trial infrastructure in Kazakhstan, built by biotech operators and investors. It lists locations in New York, Dubai, and Astana, and its site footer uses the name “Vantage Clinical Trials.” The Vantage Brief lists Charlie Regis, Almas Kenessary, and Zach Lomis as co-founders and partners, and Didar Bitmanov as chief operating officer (COO).
• Vantage Clinical Trials (vantagetrials.com). An independent clinical research site network in the Tampa Bay area of Florida, founded in 2018, with sites in Tampa, St. Petersburg, and The Villages.

This page is about the first one.

What Vantage says it offers in Kazakhstan

Vantage calls itself “the Kazakhstan layer”: the in-country platform, while sponsors keep flexibility on which CRO they use. Its website lists four parts:

• Government integration. Direct ministerial relationships and sovereign backing.
• Site and principal investigator (PI) network. Government-owned hospitals, Joint Commission International (JCI)-accredited facilities, and in-country site contracting, qualification, and activation.
• Accelerated recruitment. A centralized digital health database that Vantage says covers 20 million citizens.
• Regulatory navigation. Local approvals coordinated with Kazakhstan’s National Center for Drugs and Medical Devices Evaluation, with protocols built around International Council for Harmonisation (ICH) E6(R2) Good Clinical Practice (GCP).

Vantage describes itself as CRO-agnostic. Sponsors can bring their existing CRO, or Vantage coordinates with global CROs. Its newsletter names Tigermed as its global CRO partner. Its feasibility form covers first-in-human and proof-of-concept (POC) studies through Phase 3. Its June 2026 newsletter describes a first-in-human feasibility study of a bioresorbable peripheral vascular scaffold at a national hospital in Astana.

Vantage also publishes performance figures for Kazakhstan, such as 2–3x faster enrollment, 20–30% of Western cost, and 250+ completed and ongoing trials in the country. Those are Vantage’s figures. bioaccess® has not independently checked them, and we do not repeat them as our own. If a number matters to your budget, ask Vantage what it is based on.

Where Latin America fits

Kazakhstan and Latin America are not an either/or choice. They can answer different questions in an early-stage plan. bioaccess® has focused on first-in-human and early feasibility studies (EFS) since 2010. Most of our sponsors are U.S. medical device startups. We anchor on U.S. regulatory strategy and run studies across a defined list of 19 Latin American and Caribbean countries.

Three situations where Latin America is worth a look alongside a Kazakhstan plan:

1. Device-first programs. If your first human milestone is a device FIH or EFS, Latin America offers pre-qualified sites with small-cohort device experience, in time zones close to the U.S. Later-phase or larger cohorts can go wherever your regulatory strategy points, Kazakhstan included.
2. A second geography. Early-phase plans often stall for reasons unrelated to the science: a site’s calendar, an import permit, a regulator’s queue. A second country in a different region lowers single-country risk.
3. Hands-on oversight from the U.S. Some sponsor teams want to be in the room for the first cases. Short flights and overlapping working hours make that practical in Latin America.

Neither region is automatically faster or cheaper for every protocol. Match the geography to the device, the U.S. Food and Drug Administration (FDA) pathway, and what your investors need to see.

At a glance

	Kazakhstan via Vantage	Latin America via bioaccess®
What it is	In-country platform: government integration, sites, recruitment, regulatory navigation (per vantage-ct.com)	First-in-human CRO: U.S. regulatory anchoring plus Latin American execution (per bioaccessla.com)
CRO model	CRO-agnostic; names Tigermed as global CRO partner	bioaccess® is the CRO
Stages listed publicly	FIH and POC through Phase 3	FIH and EFS
Geography	Kazakhstan; offices listed in New York, Dubai, Astana	19 Latin American and Caribbean countries; headquartered in Miami
Sites	Government-owned hospitals and JCI-accredited facilities	50+ pre-qualified sites
FDA rule for foreign data	Vantage cites 21 CFR 312.120 (U.S. Code of Federal Regulations; drugs and biologics)	21 CFR 812.28 (devices); eligibility is not clearance
First contact	info@vantage-ct.com	Schedule time with Julio Martinez-Clark

FDA and foreign data, briefly

FDA does not keep a country scorecard. For drugs and biologics, FDA considers foreign clinical data under 21 CFR 312.120. For devices, 21 CFR 812.28 lets FDA accept data from studies outside the U.S. to support an investigational device exemption (IDE) or a marketing submission, when the study followed GCP (for devices, usually ISO 14155, the International Organization for Standardization standard for device trials), had independent ethics review and informed consent, and FDA can validate the data, including by inspection if needed. Eligibility is not clearance or approval. Plan the bridge with FDA early, usually through a Pre-Submission meeting. More detail: Does the FDA accept clinical data from Latin America? and Can first-in-human data from outside the U.S. support an FDA IDE submission?

Related pages

• Kazakhstan as a first-in-human destination
• Other Eurasia destinations: Georgia, Uzbekistan, Armenia, Moldova
• bioaccess®, The First-in-Human CRO and countries we serve

Frequently asked questions

Is Vantage Clinical the same company as Vantage Clinical Trials in Florida?

No. Vantage Clinical (vantage-ct.com) is a clinical trial platform focused on Kazakhstan, with offices listed in New York, Dubai, and Astana. Vantage Clinical Trials (vantagetrials.com) is an independent research site network in the Tampa Bay area of Florida, founded in 2018. They are separate organizations.

Is bioaccess® part of Vantage?

No. bioaccess® and Vantage are independent companies. bioaccess® is The First-in-Human CRO, headquartered in Miami and focused on the U.S. and Latin America. If your plan includes both Kazakhstan and Latin America, tell us and we will coordinate with your Kazakhstan partner.

Does Vantage run medical device trials?

Vantage’s feasibility form lists first-in-human and proof-of-concept studies through Phase 3, and its June 2026 newsletter describes a first-in-human feasibility study of a bioresorbable peripheral vascular scaffold at a national hospital in Astana. For specifics on devices in Kazakhstan, ask Vantage directly.

Will the FDA accept data from Kazakhstan or Latin America?

FDA decides case by case, not by country. It considers foreign drug and biologic data under 21 CFR 312.120 and foreign device data under 21 CFR 812.28, looking at GCP compliance, ethics review, informed consent, and whether it can validate the data. Eligibility is not clearance or approval, so align the plan with FDA early, usually through a Pre-Submission meeting.

Can one program use both Kazakhstan and Latin America?

Yes. Sequencing the two regions is usually simpler than running both under one protocol at the same time, because each has its own regulator, ethics committees, language, and import logistics. One sequence to consider: a device first-in-human or early feasibility study in Latin America, then larger or later-phase cohorts wherever your regulatory strategy points.

How do I start a conversation?

For Kazakhstan feasibility, contact Vantage at info@vantage-ct.com. For a device first-in-human or early feasibility study in Latin America, schedule time with Julio Martinez-Clark, CEO of bioaccess®, at bioaccessla.com/schedule-time-with-julio-martinez-clark.

Next step

Planning a device first-in-human study and weighing Kazakhstan, Latin America, or both? Schedule time with Julio Martinez-Clark, CEO of bioaccess®.

Schedule time with Julio Martinez-Clark

General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Kazakhstan and is not affiliated with any company named here.

If you searched for “Kazakhstan device trial approval”, you probably want to know who approves an interventional medical device study there, what standards apply, and whether it makes sense for a first-in-human (FIH) or early feasibility study (EFS). This page summarizes the framework from public legal sources and then compares it fairly with a Latin American start.

Who approves an interventional device trial

A legal overview published on Legal 500 describes three steps:

1. Expert review. The National Center for Expertise of Medicines and Medical Devices examines the clinical trial materials and issues a conclusion.
2. Bioethics review. The Central Commission on Bioethics reviews interventional trials of foreign-produced medicines and devices, as well as trials at two or more centers in Kazakhstan. Local bioethics commissions handle single-center studies, except interventional trials of products made outside Kazakhstan. For a foreign device FIH, plan on the Central Commission.
3. Permission. The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare issues the permit and conducts clinical-trial inspections.

The legal framework

The same overview lists the main instruments:

• The Code on Public Health and the Healthcare System (No. 360-VI, 7 July 2020).
• The Eurasian Economic Union (EAEU) Rules of Good Clinical Practice (Decision No. 79, 3 November 2016) and Kazakhstan’s own good clinical practice (GCP) standard (Order ҚР ДСМ-15, 4 February 2021).
• ISO 14155 through Eurasian Economic Commission Recommendation No. 17 (4 September 2017) on device trials involving human subjects.
• The rules for conducting clinical trials and the requirements for clinical sites (Order ҚР ДСМ-248/2020, 11 December 2020).

Other points from the overview that matter for planning:

• Site requirements: a medical license, standard operating procedures (SOPs) for trials, suitable equipment or contracted services, GCP-trained staff, and intensive care capability where the protocol requires it.
• Participant restrictions: interventional trials may not enroll military or law-enforcement personnel, employees of the medical organization where the research takes place, or people in penal institutions.
• Records: the sponsor and investigator must archive trial documents for 25 years after completion.
• The overview notes that draft amendments were under public discussion when it was published, so confirm the current text.

What is published about timelines

We did not find an official, device-specific end-to-end timeline in the sources above. Ask for a written calendar that covers the expert review, the Central Commission on Bioethics and the Ministry permit.

Standards and U.S. data acceptance

The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under GCP, with independent ethics review and informed consent, and FDA can validate the data. That data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Kazakhstan’s reference to ISO 14155 fits that expectation. What matters is how the study is actually run.

Patients, sites and device experience

• Population: about 20.6 million (World Bank, 2024).
• ClinicalTrials.gov (28 September 2026): 26 interventional device records list a site in Kazakhstan. None has “device feasibility” as its primary purpose, which suggests early-device experience is still limited.
• Kazakhstan does not appear on Clinical Accelerator’s public coverage map.

Recruitment reality: with a thin FIH track record, you will depend more heavily on individual investigators’ experience with your device type. Strict inclusion criteria can shrink eligible pools quickly. Verify screening numbers for your criteria at each named site.

Logistics from the United States

• Time zone: Astana is on UTC+5 (Coordinated Universal Time plus five hours), 9–10 hours ahead of U.S. Eastern time.
• Languages: Kazakh and Russian. Confirm the translation requirements for the protocol and informed consent form (ICF).
• Check the U.S. Department of State travel advisory and current routings.

Genuine strengths

Kazakhstan has a codified framework that explicitly references ISO 14155 and EAEU GCP, a defined inspection authority, clear site requirements, and a mid-sized population. For sponsors who also have Eurasian market plans, running work there can be strategically useful.

How Latin America compares

• Same FDA rule: 21 CFR 812.28.
• Early-device track record: on ClinicalTrials.gov, Panama has 5 records with “device feasibility” as their primary purpose, Chile 4 and Brazil 15.
• Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997. See our Argentina hub.
• Time zone: 0–2 hours from U.S. Eastern.
• U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
• Trade-offs: Spanish or Portuguese documents and investigational import permits.

Other country guides: Uzbekistan

Frequently asked questions

Who issues permission for a device trial in Kazakhstan?

The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare issues the permit. It relies on a conclusion from the National Center for Expertise of Medicines and Medical Devices and a bioethics opinion.

Which ethics body reviews a foreign device trial?

For interventional trials of foreign-produced devices, the Central Commission on Bioethics reviews the study, according to the published legal overview.

Does Kazakhstan follow ISO 14155?

Yes. A Eurasian Economic Commission recommendation on device good clinical practice, based on ISO 14155, is part of the framework.

Will the FDA accept data from Kazakhstan?

It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.

How long does approval take?

We found no official device-specific figure. Ask for a written calendar.

Next step

Comparing Kazakhstan with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Uzbekistan and is not affiliated with any company named here.

Uzbekistan is newer to device trials and is drawing attention from MedTech sponsors. ClinicalTrials.gov already lists device studies with Uzbek sites that are explicitly labelled first-in-human (FIH), such as NCT07811024 and NCT06700226. If you searched for “clinical trials Uzbekistan medical device”, this page covers the new rules, what the country offers, and how a Latin American FIH compares.

The 2026 device-trial regulation

The Minister of Health approved a Regulation on the procedure for conducting clinical trials of medical equipment. It was registered by the Ministry of Justice on 7 January 2026 (No. 3746) and published in the state language, Uzbek. According to the legal news service Norma.uz, it entered into force on 26 February 2026. Summaries by Norma.uz and a Tashkent law firm describe these main points:

• Exemptions from clinical trials for registration: Class I (low-risk) devices, in vitro diagnostics prequalified by the World Health Organization (WHO) or registered with WHO support, devices already clinically tested in Uzbekistan, and, per the law firm, some devices with a proven record of safe use.
• Who decides: an Expert Council of the Ministry of Health decides whether a trial is required, on the recommendation of the Center for the Safety of Pharmaceutical Products.
• Minimum size: trials under the regulation must enroll at least 20 subjects, scaled to the device’s risk class, and multi-center designs are possible for higher-risk devices.
• Parallel review: under the medical device registration rules adopted in November 2025, laboratory testing and specialized expert review run at the same time. An independent expert checks the clinical site, the trial design and the assessment methods.
• Ethics: a trial cannot start without a positive opinion from the designated ethics committee. Written informed consent is required.
• Sponsor duties: providing the device, insuring subjects, monitoring and auditing, and reporting adverse events.

An important caveat for FIH planning: the regulation is written around state registration in Uzbekistan. How it applies to a foreign sponsor’s small FIH protocol that is not aimed at Uzbek registration, including the 20-subject minimum, is something to confirm in writing with local regulatory counsel before you commit.

What is published about timelines

We found no official end-to-end timeline for device trials under the 2026 regulation. Because the rules are new, treat any quoted clock as an estimate until you have a written, study-specific calendar.

Standards and U.S. data acceptance

The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study is well designed and well conducted under good clinical practice (GCP), with independent ethics review and informed consent, and FDA can validate the data. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Plan to run to ISO 14155, the international GCP standard for device investigations, whatever the local minimum requires.

Patients, sites and device experience

• Population: about 36.4 million (World Bank, 2024).
• ClinicalTrials.gov (28 September 2026): 23 interventional device records list an Uzbek site, and 3 have “device feasibility” as their primary purpose. The footprint is small but growing.
• Clinical Accelerator lists Uzbekistan on its coverage map and names a country lead there.

Recruitment reality: a large national population does not mean a large eligible pool at the sites you will actually use. Strict inclusion criteria and referral patterns concentrated in a few hospitals can slow enrollment. Ask for site-level screening numbers for your criteria.

Logistics from the United States

• Time zone: Tashkent is on UTC+5 (Coordinated Universal Time plus five hours), 9–10 hours ahead of U.S. Eastern time.
• Language: the regulation is published in Uzbek. Confirm the translation requirements for the protocol and informed consent form (ICF).
• Check the U.S. Department of State travel advisory and current flight routings before you plan visits.

Genuine strengths

Uzbekistan has a sizeable population, a brand-new device-trial rulebook with defined exemptions and a parallel-review design, and FIH device studies already on ClinicalTrials.gov. For sponsors who want an emerging geography with engaged investigators, it is worth evaluating.

How Latin America compares

• Same FDA rule: 21 CFR 812.28.
• Established pathways: Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária) regulates device investigations under RDC 837/2023, and our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
• Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination.
• Time zone: 0–2 hours from U.S. Eastern, compared with 9–10 for Tashkent.
• U.S. continuity: bioaccess® is headquartered in Miami, and its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
• Trade-offs: Spanish or Portuguese documents and investigational import permits.

Other country guides: Kazakhstan

Frequently asked questions

Does Uzbekistan have rules for medical device clinical trials?

Yes. A Ministry of Health regulation on clinical trials of medical equipment was registered on 7 January 2026 (No. 3746) and took effect on 26 February 2026.

Who decides whether a device trial is needed in Uzbekistan?

An Expert Council of the Ministry of Health decides, on the recommendation of the Center for the Safety of Pharmaceutical Products. A positive ethics committee opinion is required before the trial starts.

Is there a minimum number of patients?

Published summaries say trials under the regulation must enroll at least 20 subjects. Confirm how this applies to a small FIH protocol that is not aimed at Uzbek registration.

Will the FDA accept data from Uzbekistan?

It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.

Next step

Weighing Uzbekistan against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

Sponsors comparing Latin American countries often hear a shortcut about Chile: device studies only need ethics approval and an import permit, and the regulator stays out of the way. That shortcut is out of date. Chile’s Instituto de Salud Pública (ISP) authorizes both drug trials and device trials. The real differences sit somewhere else: in which agency inside ISP handles the file, which rules were written with devices in mind, and how settled the device guidance is.

The short version

• Same legal gate. Since Ley 20.850 (2015), Código Sanitario Article 111 A requires an ISP “autorización especial para uso provisional con fines de investigación” for pharmaceutical products and medical devices (“elementos de uso médico”) used in research on humans.
• Ethics first. The ISP application comes after approval under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC).
• Different agencies. Drugs go through ISP’s Agencia Nacional de Medicamentos (ANAMED). Devices go through the Agencia Nacional de Dispositivos Médicos (ANDIM).
• Different rulebooks. Several older Chilean research instruments, including Norma Técnica 57, were written for medicines. The device route rests mainly on the Código Sanitario and device-specific ISP guidance, and some of that guidance is still being finalized.

Two agencies inside one institute

ISP is Chile’s national regulator for medicines and medical devices. Drug work, including ISP’s clinical studies pages for investigational medicines, sits under ANAMED. Device work sits in ANDIM. On its agency page, ISP describes ANDIM as responsible for the safety and performance of medical devices, including in vitro diagnostic devices (IVDs), through authorization, control, inspection and surveillance across the whole device life cycle.

A standalone device goes to ANDIM. A combination product may involve both.

What is the same for drug and device trials

The CEC review comes first

Ley 20.120 is Chile’s law on scientific research in human beings. Its regulation, Decreto Supremo (DS) 114 of 2010, as amended in 2013, requires every study to have “una revisión e informe favorable de un Comité Ético Científico acreditado.” For multicenter studies, one accredited committee does the scientific and ethical review, and each site adds a local feasibility evaluation. Under DS 114 Article 18, the CEC must issue its report within 45 days of submission, a deadline it can extend once by 20 days for stated reasons.

Article 111 A then makes the order explicit: the ISP application is filed “previa aprobación conforme a lo dispuesto en el artículo 10 de la ley N°20.120,” with the protocol, the informed consent form, the insurance policy and any other document the regulation requires. For devices and drugs alike, the CEC letter comes before the ISP file.

ISP issues a provisional-use authorization

Article 111 A says the authorization is required for any drug or medical device used in research that lacks a sanitary registration, or that has one but will be used differently from how it was registered. The authorization lasts up to one year and can be renewed. The product can only be used as the authorization allows, and ISP must keep a public registry of the research it authorizes.

Shared obligations during and after the study

• Safety reporting: adverse events go to ISP and the CEC, under pharmacovigilance rules for drugs and technovigilance rules for devices (Article 111 B).
• Post-trial access: the authorization holder must continue treatment at no cost while it remains useful, as described in the protocol (Article 111 C). Our note on post-trial access in Chile under Ley 20.850 covers how this works in practice.
• Site accreditation and inspection: research centers must be accredited by ISP, which can inspect protocols, consent, GCP compliance and safety reporting (Article 111 D).
• Liability and insurance: authorization holders are liable for harm caused by the research (Article 111 E) and must carry civil liability insurance under the applicable regulation (Article 111 F). For devices, Article 111 F says a supreme decree sets the device classes for which insurance is mandatory. Our note on Chile clinical trial insurance covers the ethics-committee side.
• Institutional sign-off: under DS 114 Article 10 bis, the director of each research site authorizes the study within 20 business days of the favorable CEC review and, where applicable, the ISP authorization.

Where drug and device trials genuinely differ

The older rulebook was written for medicines

Much of what sponsors read about Chilean trial rules comes from instruments that name drugs, not devices:

• Código Sanitario Article 99 lets ISP provisionally authorize the use of pharmaceutical products without registration for clinical trials, subject to a favorable CEC report.
• DS 114 Article 7 gives ISP the power to “autorizar el uso de medicamentos con o sin registro sanitario, con fines de investigación científica y ensayos clínicos.” The article speaks of medicines only.
• Norma Técnica 57, approved by Ministry of Health (MINSAL) Exempt Resolution 952 of 2001, is titled “Regulación de la ejecución de ensayos clínicos que utilizan productos farmacéuticos en seres humanos.”

For devices, the legal basis is Código Sanitario Article 111 A. It is backed by Article 111 letter g, which says ISP must authorize the use and disposal of the medical elements covered by Article 111, and by DS 825 of 1998, the regulation on the control of medical-use products and elements. A drug-trial checklist will not map cleanly onto a device file.

What ISP looks at

For drugs, ISP has said publicly that it assesses the investigational medicine “teniendo a la vista el protocolo del ensayo clínico, el manual del investigador y certificaciones” such as Good Clinical Practice (GCP) and Good Manufacturing Practice, and decides by reasoned resolution (ISP, 2020).

For devices, ISP ran a public consultation from 5 June to 5 July 2026 on a guide explaining how to organize an application for provisional-use authorization of a medical device in clinical research in humans. Check whether the final guide has been published before you assemble your file. Until it is, build the dossier around ISO 14155:2020, the international standard for good clinical practice in medical device investigations: the clinical investigation plan, the investigator’s brochure, and the risk analysis behind them. Then confirm the exact document list with ANDIM.

A possible exemption for low-risk devices

Article 111 A lets MINSAL exempt, by supreme decree, “los elementos de uso médico cuya utilización no conlleve un riesgo relevante para las personas.” Article 111 A offers no equivalent carve-out for drugs. We have not confirmed that an exemption decree is in force, so treat this as something to check for your device, not an assumption.

Commercial registration status plays a different role

Most medical devices in Chile still do not need an ISP sanitary registration to be sold. ISP’s own registration page lists a short set of products 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. Exempt Decree 25 of 2026 adds 39 more. Registration becomes mandatory for 13 of them 24 months after publication (19 March 2028) and for the other 26 after 36 months (19 March 2029). The decree governs manufacture, import, sale and distribution, and it does not mention clinical investigation. An investigational device therefore does not need a registro sanitario. It needs the Article 111 A authorization. Our Chile ISP clinical-trial path for medical devices explains how to keep the trial file and the Decree 25 registration file on separate timelines.

What this means for your timeline

Because the CEC review comes before the ISP application, a Chilean device study runs in sequence: ethics review, then ISP authorization and investigational import, then the site director’s authorization. The primary sources set some of the clocks: 45 days for the CEC report (extendable once by 20 days) and 20 business days for the site director. For the ISP step, our Chile ISP device trial page plans on about 30 business days after a complete package, to be confirmed at filing. For overall site activation, our phase-by-phase site activation timeline guide shows that, in our recent plans, ethics and regulatory approval of a complete submission in the fast-corridor countries, Chile included, took about 1 to 3 months, and activation from protocol synopsis to first patient about 8 to 9 months. Treat both as planning figures, not guarantees.

So the fair comparison with the US is not “no regulator review in Chile.” It is an ISP device authorization that follows an accredited CEC review, with legal deadlines on the ethics and site-director steps.

Chile, IMDRF and using the data elsewhere

ISP says Chile has been an affiliate member of the International Medical Device Regulators Forum (IMDRF) since November 2023. Affiliate status signals regulatory convergence. It does not mean ISP accepts another regulator’s decision in place of its own trial authorization.

If you plan to use Chilean data outside Chile, design the study for that from day one. Under 21 CFR 812.28, the US Food and Drug Administration (FDA) can accept a foreign clinical investigation that supports an investigational device exemption (IDE) or a marketing submission, if the study was well designed, well conducted and followed GCP, including independent ethics committee review and informed consent, and FDA is able to validate the data, by inspection or other means if needed. In Europe, the EU Medical Device Regulation (MDR) 2017/745 sets out clinical investigation requirements in Article 62 and Annex XV. Your notified body will judge how data generated outside the EU fits your clinical evaluation.

Checklist for device sponsors considering Chile

• Confirm the file goes to ANDIM, and flag early any drug or biologic component.
• Choose a lead accredited CEC and each site’s local review route before you finalize the protocol.
• Prepare the Article 111 A package: protocol, Spanish informed consent form, insurance policy, and ISO 14155-aligned device documents.
• Check whether ISP has published the final device provisional-use guide, and whether any low-risk exemption or insurance-class decree applies to your device.
• Plan investigational import alongside the ISP step, not after it.
• Keep any Decree 25 commercial registration work on a separate timeline.

Frequently asked questions

Does Chile’s ISP approve medical device clinical trials, or only the import?

ISP does more than clear the import. Código Sanitario Article 111 A, added by Ley 20.850 in 2015, says drugs and medical devices used in research on humans need a special provisional-use authorization from ISP. That applies when the device has no sanitary registration, or when it has one but will be used differently from how it was registered.

Does the ethics committee or ISP go first in Chile?

The ethics committee goes first. Under Article 111 A, the sponsor files with ISP only after the study has been approved under Article 10 of Ley 20.120, which requires a favorable report from an accredited Comité Ético Científico (CEC). The application must include the protocol, the informed consent form and the insurance policy.

Does Norma Técnica 57 apply to medical device trials?

Not on its face. Norma Técnica 57, approved by Ministry of Health Exempt Resolution 952 of 2001, regulates clinical trials that use pharmaceutical products in humans. The device rules come from Código Sanitario Articles 111 and 111 A, Decreto Supremo 825 of 1998 and ISP guidance. Confirm current requirements with ISP.

Does an investigational device need a registro sanitario before a trial in Chile?

No. Commercial sanitary registration and research use are separate. Article 111 A covers devices that do not have a registration, which is why the trial needs ISP’s provisional-use authorization instead. Exempt Decree 25 of 2026 widens commercial registration but says nothing about clinical investigations.

Can data from a Chile device study support an FDA or EU submission?

It can, if the study is designed for that. Under 21 CFR 812.28, FDA can accept a well-designed, well-conducted foreign study that followed good clinical practice, including independent ethics review and informed consent, if FDA can validate the data. For Europe, plan against EU MDR Article 62 and Annex XV. Acceptance is decided case by case.

This article is general information, not legal advice. Requirements change, and ISP’s device research guide was under public consultation in 2026. Verify current requirements with ISP and your CEC before filing.

Considering Chile for a device study? bioaccess® can map feasibility, CEC routes, ISP authorization and site access for your protocol. Contact bioaccess® at bioaccessla.com to start.

Names and roles cited from live ClinicalTrials.gov records NCT07461818, NCT06815939, NCT07538050, and NCT07232355 (overall-official, central-contact, and location-contact fields), checked 27 September 2026. Registry rows are not a bioaccess® claim that we ran these studies. General information, not legal or regulatory advice. Confirm current El Salvador and U.S. regulatory and ethics rules with qualified advisers. We do not reprint emails or phones and do not add affiliations beyond the registry strings cited here.

If you searched Karla Alfaro MD El Salvador, Dr Karla Alfaro clinical trial, Karla Alfaro Basic Health International, or “go direct to Karla Alfaro,” you followed investigator and contact strings ClinicalTrials.gov publishes. The work visible on those records is cervical cancer screening and pre-cancer treatment in El Salvador. A named principal investigator is not a first-in-human (FIH) medical-device contract research organization (CRO), and a personal reply is not the operator of the national file.

bioaccess®’s position is simple and it is not adversarial: the investigator is part of the site. The CRO still owns the Superintendencia de Regulación Sanitaria (SRS) and Comité Nacional de Ética de la Investigación en Salud (CNEIS) filings, investigational import, insurance, ISO 14155 monitoring, and the 21 CFR 812.28 package.

Registry roles, copied as listed (checked 27 September 2026)

Registry count: ALL 4 / DEVICE 2. All four records are listed as RECRUITING.

Record	Sponsor	Type / intervention	Status	Role(s) listed for Karla Alfaro
NCT07461818 (POC)	Basic Health International, Inc.	Interventional; IRIS™ Thermal Ablation Device (DEVICE); estimated 5,000	RECRUITING	Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with Rachel Masch, MD; central CONTACT
NCT06815939 (OPTICS)	DL Analytics	Interventional screening; interventions include the EVA System (DEVICE); estimated 10,000	RECRUITING	Overall PRINCIPAL_INVESTIGATOR (affiliation Basic Health International, Inc.), shared with David Levitz, PhD (DL Analytics); site PRINCIPAL_INVESTIGATOR and CONTACT at “Ministerio de Salud,” San Salvador
NCT07538050 (SCALE AIM 2)	The Cleveland Clinic	Interventional; same-day screen and treat (BEHAVIORAL); estimated 1,000	RECRUITING	Site PRINCIPAL_INVESTIGATOR and CONTACT (listed as “Karla Alfaro, MD, MPH”) at “Ministry of Health Clinics,” San Salvador
NCT07232355 (PROGRESS)	Atila Biosystems Inc.	Observational; estimated 5,000	RECRUITING (see note)	Site CONTACT at Basic Health International, San Salvador

Notes from the records themselves: OPTICS lists an estimated primary completion of 31 July 2026, which has passed, and an estimated study completion of 31 December 2026. PROGRESS lists estimated completion in June 2026, which has passed, and was last updated 19 November 2025, so its recruiting status is unconfirmed. SCALE AIM 2 started 16 April 2026. POC started 1 January 2026. None of the four records calls itself first-in-human, and none names a CRO.

Facility page for the site she is most often tied to on the registry: Basic Health International San Salvador. The Ministry of Health locations are listed only as generic strings (“Ministerio de Salud,” “Ministry of Health Clinics”), so we do not name a specific clinic.

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

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

• Discuss investigator interest and whether a protocol fits an existing service.
• Share local research rules and how the cases would physically run.
• Estimate local visit, staffing, and procedure effort for the cases they will run.

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

• SRS authorization and the CNEIS packet, filed in parallel on the national digital platform.
• Investigational import and device accountability — see importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a premium here.
• ISO 14155 monitoring, electronic data capture (EDC), serious adverse event (SAE) reporting, and the trial master file (TMF).
• The 21 CFR 812.28 package. Eligibility is not clearance, and a site agreement does not produce it.

Going direct is how you confirm a room and a person. It is not how you open an investigational file.

Regulator, ethics, timeline, and cost (published figures)

These lines are copied from the published bioaccess® post El Salvador first-in-human cost and timeline vs the United States, not re-averaged here:

• The live El Salvador hub already publishes a 30–60 day study-startup band via parallel review by the Superintendencia de Regulación Sanitaria (SRS) and the Comité Nacional de Ética de la Investigación en Salud (CNEIS) on one digital platform. That band is investigation authorization plus ethics — not commercial registro.
• SRS replaced the former Dirección Nacional de Medicamentos (DNM) in August 2024. Ethics stays centralized at CNEIS.
• The El Salvador hub already publishes roughly 60% cost savings versus equivalent U.S. programs, plus a dollarized (U.S. dollar) economy. That is orientation from the country page, not a formal study for your device.

Ask for a study-specific calendar before you put a single date on a board slide. A site email is not an SRS authorization. Trial authorization and commercial registro are separate files; see CNEIS/SRS trial authorization vs registro.

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Foreign clinical data can be eligible for U.S. Food and Drug Administration (FDA) submission and review under 21 CFR 812.28. Eligibility is not clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the investigator

Karla Alfaro, MD is a named principal investigator on public cervical-screening and pre-cancer treatment records in El Salvador. That is evidence of a person doing registered research, not a punchline. Roles are as listed. Hire the operator. Activate a site only if it fits.

Colombia note

Colombia remains a strong market-access geography and a historical first-in-human geography for bioaccess®. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. We pick the country the device needs.

Frequently asked questions

Can I email Karla Alfaro, MD directly about a device study?

You can try through whatever channel the public registry exposes. A named investigator can discuss clinical interest. That person cannot, by appearing on ClinicalTrials.gov, become your SRS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager.

What roles does ClinicalTrials.gov show for her?

Overall PRINCIPAL_INVESTIGATOR on NCT07461818 and NCT06815939; central CONTACT on NCT07461818; site PRINCIPAL_INVESTIGATOR and CONTACT on NCT06815939 and NCT07538050; site CONTACT on NCT07232355.

Did bioaccess® run any of these studies?

No public bioaccess® page says so, and the records do not name a CRO. We will not invent that claim.

Next step

Start as the operator: contact bioaccess® or First-in-Human CRO. Country system: clinical trials in El Salvador. Facility sibling: Basic Health International San Salvador.