Category: Advantages of Conducting Trials in Latin America

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 ANMAT, 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 Hospital Rawson Córdoba as a bioaccess® client.

If you searched Hospital Rawson Cordoba first-in-human, Rawson Córdoba clinical trial, Rawson CRO, or “go direct Hospital Rawson Córdoba,” you followed a campus string ClinicalTrials.gov still publishes. Hospital Rawson in Córdoba, Argentina, is a real named hospital string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANMAT file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ANMAT, 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 hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Córdoba Hospital Rawson campus. It is not Vélez Sársfield Córdoba, not Instituto DAMIC / IIC / CEMAIC (already published), not Sanatorio Allende (already published), and not Centro Urológico Profesor Bengió. Sharing Córdoba 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 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.

• Hospital Rawson (Córdoba, Argentina) — canonical NCT string: ALL interventional n=12; DEVICE n=0. Example NCT IDs: NCT00867048, NCT00931463, NCT01227967.

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 Rawson Córdoba first-in-human” finds ALL n=12 (DEVICE n=0) without finding ANMAT. A named hospital 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:

• ANMAT. Argentina’s national medicines and devices authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the file a sponsor actually needs. A hallway conversation on this campus is not that file. A published statutory target on the trial side is 90 business days and the clock pauses for RFIs. Trial authorization and commercial registro are separate petitions. A hallway conversation at Rawson is not a Vélez Sársfield 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 ANMAT actually works (the short version)

Use live bioaccess® Argentina / ANMAT pages for the full pathway. Trial authorization and commercial registro are different petitions. Do not put both on one Gantt labeled “Argentina.” A published statutory target on the trial side is on the order of 90 business days and pauses for RFIs; ask for a protocol-specific calendar rather than treating an NCT row as start-up.

Ask for a protocol-specific calendar. A hospital email is not ANMAT 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

Hospital Rawson is a serious named Córdoba hospital on the public registry. ALL n=12 is registry volume, not a punchline. We do not invent a DEVICE n. 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 ANMAT / 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 Hospital Rawson Córdoba 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 ANMAT 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 Vélez Sársfield Córdoba?

No. Vélez Sársfield Córdoba has its own page. This page is Hospital Rawson only.

Did bioaccess® run NCT00867048?

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. Córdoba sibling (do not merge): Vélez Sársfield Córdoba.

Julio G. Martinez-Clark, CEO · bioaccess®

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 Las Condes Santiago as a bioaccess® client.

If you searched Clinica Las Condes first-in-human, Las Condes Santiago clinical trial, Las Condes CRO, or “go direct Clínica Las Condes Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Clínica Las Condes in Santiago, Chile, is a real named private-hospital string on ClinicalTrials.gov. 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 hospital is the site. The First-in-Human CRO still owns ISP, Ethical-Scientific Committee / Law 20.120, 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 Santiago Clínica Las Condes campus. It is not Clínica Dermacross Santiago, not Psicomed Antofagasta, not Centro Vanguardia Temuco, and not PUC Chile (not covered on this page). Sharing Santiago is not a license to collapse them. Las Condes is not PUC.

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.

• Clinica Las Condes (Santiago, Chile) — canonical NCT string: ALL interventional n=11; DEVICE n=1. Example NCT IDs: NCT00026338, NCT00080340, NCT00151892. Accent alias Clínica Las Condes ALL n=7, DEVICE n=0 listed separately — not combined.

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 “Las Condes first-in-human” finds ALL n=11 (DEVICE n=1) without finding ISP. A named clínica 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 Las Condes is not a Dermacross 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 Las Condes is a serious named Santiago hospital on the public registry. ALL n=11 is registry volume, not a punchline. We do not invent a DEVICE n beyond 1. PUC Chile is not covered on this page. 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 Las Condes Santiago 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, 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 Dermacross or PUC Chile?

No. Clínica Dermacross has its own page. PUC Chile is not covered on this page. This page is Las Condes only.

Did bioaccess® run NCT00026338?

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. Santiago sibling (do not merge): Dermacross Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

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 COFEPRIS, 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 Arké SMO Veracruz as a bioaccess® client.

If you searched Arke SMO Veracruz first-in-human, Arké SMO clinical trial, Arke SMO CRO, or “go direct Arké SMO Veracruz,” you followed a campus string ClinicalTrials.gov still publishes. Arké SMO S.A. de C.V. in Veracruz, Mexico, is a real named site-management / research-site string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: the site is the site. The First-in-Human CRO still owns COFEPRIS, 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 site still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Veracruz Arké SMO campus. It is not Instituto Veracruzano de Investigación Clínica, not Instituto Jalisciense, not Universidad de Guadalajara (already published), and not Scientia Chihuahua (already published). Sharing Mexico is not a license to collapse them. Veracruz is not Guadalajara.

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.

• Arké SMO S.A de C.V (Veracruz, Mexico) — canonical NCT string: ALL interventional n=27; DEVICE n=0. Example NCT IDs: NCT03952559, NCT04184622, NCT04772079. Alias strings (listed separately, not combined): Arke SMO S.A. de C.V. ALL n=5; Arke SMO SA de CV ALL n=2.

We do not invent a DEVICE n.

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 site as a client site.

That is the leak: a founder searching “Arké SMO first-in-human” finds ALL n=27 (DEVICE n=0) without finding COFEPRIS. A named SMO 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 site 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 site 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 site 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 Arké SMO is not an Instituto Veracruzano 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 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 OUS FIH and FDA IDE.

Not a critique of the hospital

Arké SMO is a serious named Veracruz research site on the public registry. ALL n=27 is registry volume, not a punchline. We do not invent a DEVICE n. 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 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-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 Arké SMO Veracruz directly for a device FIH?

You can try. The site can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your COFEPRIS 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 site. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Instituto Veracruzano?

No. Instituto Veracruzano de Investigación Clínica has its own page. This page is Arké SMO Veracruz only.

Did bioaccess® run NCT03952559?

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. Veracruz sibling (do not merge): Instituto Veracruzano.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ANVISA holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched Brazil ANVISA registration holder IOR, Brazil Registration Holder BRH detentor, ANVISA importer of record, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

Brazil is the BRH / detentor search. Freyr, Emergo, Pure Global, MedEnvoy, and Qserve all appear next to ANVISA holder language on public pages. Brazil pricing: a one-time registration fee of $6,750 (Class I/II) or $22,250 (Class III/IV), then an annual holder fee from year 2 of $6,000 (Class I/II) or $7,500 (Class III/IV) (rate card). BGMP manufacturing-site audit and INMETRO are separate lines.

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

Appointing a BRH is not being the BRH

Qserve’s Brazil page guides appointing a BRH. Emergo publishes an independent Brazil Registration Holder page. Freyr acts as BRH and cites a partner network. Pure Global publishes own-entity BRH with a sticker that excludes government fees and certified translations. bioaccess® acts as BRH under contract, working with its local partner in Brazil, and produces sworn Portuguese pages where required. Ask which legal entity is the detentor and which entity imports.

Trial authorization is not commercial registro

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. Do not put RDC 837 trial dossiers and commercial registro on one Gantt labeled “Brazil.” This page is the commercial holder. Investigational import is a different workstream. Clementino/UFRJ is not covered on this page.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table and the SKU. This page is ANVISA BRH / detentor / IOR. distinct page. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was Brazil ANVISA registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Freyr sibling: Freyr LATAM holder.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current COFEPRIS holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched Mexico COFEPRIS registration holder IOR, Mexico Registration Holder MRH, COFEPRIS titular importer of record, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

Mexico is a live holder market: ethics and trial clocks on Clinical Trials in Mexico are a different file from registro sanitario (~30 working days on that hub). This is the commercial MRH / IOR page. Already-cleared devices. Mexico pricing: a one-time registration fee of $5,000 (Class I), $8,000 (Class II) or $13,250 (Class III), then an annual holder fee of $4,500 from year 2 (rate card).

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

MRH vs distributor importer

Emergo’s public independent Mexico Registration Holder page is why that brand ranks in this search. Independent MRH can still leave the shipment with a distributor. bioaccess® as holder asks the same two-entity question: who is on the COFEPRIS certificate, who is on the import entry. Do not collapse FDA US agent into MRH.

Registro is not FIH start-up

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. Keep trial clocks separate from registro sanitario. This SKU does not enroll patients. It holds the sanitary registration and can import the cleared device. bioaccess® runs first-in-human studies in Colombia now; the holder service is separate.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table and the SKU. This page is COFEPRIS Mexico Registration Holder / IOR. distinct page. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was Mexico COFEPRIS registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Brazil sibling: ANVISA holder / IOR.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched Colombia INVIMA registration holder IOR, INVIMA titular importer of record, CCAA holder Colombia medical device, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

This is the Colombia holder page. It is market access. It is not a new first-in-human CTA. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Use INVIMA medical device registration checklist for the controlled vs uncontrolled / foreign-holder / CCAA importer checklist. Colombia pricing: two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

What INVIMA holder actually is

INVIMA names a Colombian legal entity on the sanitary registration. Foreign manufacturers appoint that titular. CCAA importer rules sit next to the holder, not instead of it. See the live checklist. We will not invent an INVIMA tariff beyond the locked card. MedEnvoy, Pure Global, Freyr, Emergo, and Qserve may appear in the same search; none of them is this page. Named competitors stay on their own pages.

Do not mix trial IOR into commercial holder

Investigational-device import for a protocol is importer of record for clinical trial devices. Commercial IOR for an already-cleared device is this SKU. Avantec / Watershed public FIH copy that names Colombia is historic execution, not a reason to book a new INVIMA FIH from this page. Site pages stay off. Nanochon HOLD. Magical BTK off.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table and the SKU. This page is INVIMA titular / IOR (registro — not new FIH). distinct page. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was Colombia INVIMA registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Mexico sibling: COFEPRIS holder / IOR.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ANVISA / COFEPRIS / INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched Qserve LATAM market access holder, Qserve legal representation Latin America, Qserve Brazil BRH, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

Qserve Group is a global RA consultancy. The hub recorded market approval and “legal representation” across a wide LATAM/Caribbean list, and a Brazil page that guides appointing a BRH. Guiding a manufacturer to appoint a BRH is not being the BRH. We will not invent a Qserve all-in annual fee. Empty hub cells stay empty. A Caribbean country list is not an INVIMA titular, not a COFEPRIS MRH, and not an ANVISA detentor. Appointing a BRH is a how-to page, not the certificate. bioaccess® pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

Wide published country list is not the certificate

A wide South America / Central America / Caribbean list is a marketing footprint. The sanitary certificate names one legal entity per country. Ask whether Qserve’s entity is on that certificate in Mexico, Brazil, or Colombia, or whether they are the project manager who hires someone else. We do not invent extra holder brands to fill the gap.

Market approval is not tecnovigilancia as holder

Getting a registro filed is the start. Holding it — modifications, agency liaison, tecnovigilancia — is the annual card. That is the job the bioaccess® annual holder fee from year 2 covers. Qserve’s “market approval and legal representation” copy is a different sentence. Read it as project language until they name the entity on the certificate.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table and the SKU. This page is Qserve market approval / legal representation versus registration holder / IOR. distinct page. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was Qserve LATAM market-access holder, start on the holder line: contact bioaccess® or market-access. Emergo sibling: Emergo vs holder / IOR. Hub: LATAM Registration Holder and IOR.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current COFEPRIS / INVIMA / ANVISA / DIGEMID holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched MedEnvoy LATAM authorized representative, MedEnvoy Mexico Colombia Peru Brazil registration holder, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

MedEnvoy publishes independent registration-holder pages for Mexico, Colombia, Peru, and Brazil. EU “authorized representative” language is the wrong object for this search. A LATAM titular / BRH / MRH is on the sanitary certificate. An EU AR is on an EEA mandate. Do not import MDR AR vocabulary onto COFEPRIS. The hub recorded no all-in LATAM subscription SKU for MedEnvoy. We will not invent one. bioaccess® pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

Four published RH markets are not 19

Hub footprint for MedEnvoy: Mexico, Colombia, Peru, Brazil. If you need Chile ISP, Argentina ANMAT, Panama MINSA, or El Salvador DNM as holder, that is a different country list — use market-access and the hub, not an invented MedEnvoy expansion. Peru still wants a licensed droguería on import. Colombia on this page is INVIMA holder, not new FIH execution.

Independent holder still has to answer IOR

Independent RH can be the certificate and still leave the distributor as importer of record. bioaccess® holds under contract (own entity in Colombia; local partner elsewhere) and quotes import shipments separately, per shipment, with no charge if there is no import. Ask MedEnvoy the same two-entity question: certificate vs shipment.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table. This page is MedEnvoy independent RH versus bioaccess® market access, a distinct page.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was MedEnvoy LATAM authorized representative vs holder / IOR, start on the holder line: contact bioaccess® or market-access. Colombia sibling (market access only): INVIMA holder / IOR. Hub: LATAM Registration Holder and IOR.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ANVISA / COFEPRIS / INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched Freyr LATAM medical device registration holder, Freyr BRH Brazil, Freyr COFEPRIS INVIMA holder, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

Freyr Solutions acts as Brazil Registration Holder on public pages and cites an extensive Brazil partner network. The LATAM hub language on their side is Brazil / Mexico / Colombia. The locked bioaccess® hub recorded “cost-effective annual support for BRH Service” — not an all-in government-fee + translation subscription. We will not invent a Freyr dollar figure. Empty hub cells stay empty. A “cost-effective annual support” sentence is not government fees, not sworn Portuguese pages, and not tecnovigilancia as holder. bioaccess® pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

BRH support vs named on the certificate vs on the shipment

Ask whether Freyr’s legal entity is the detentor/BRH on the ANVISA certificate, whether a partner network is doing the holding, and who is importer of record. A partner network is not automatically the customs entry. Mexico COFEPRIS and Colombia INVIMA are separate titular problems. Do not put three countries on one Gantt labeled “Freyr LATAM.”

Brazil Class III/IV is not a secret extra we invent here

Brazil Class III/IV published adder + INMETRO pass-through already lives on the hub and market-access. This Freyr page does not republish a second price list. BGMP manufacturing-site audit remains outside the flat fee as already published (~USD 13,500/site on the hub). We will not invent a Freyr BGMP number.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table and the SKU. This page is Freyr annual BRH support versus registration holder / IOR. distinct page. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was Freyr as LATAM medical-device registration holder, start on the holder line: contact bioaccess® or market-access. Brazil sibling: ANVISA holder / IOR. Hub: LATAM Registration Holder and IOR.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ANVISA / COFEPRIS / INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates; bioaccess® pricing is the two-part model on the rate card. No unpublished client. Always bioaccess®.

If you searched Pure Global vs LATAM IOR, Pure Global BRH MRH INVIMA fee, Pure Global Mexico Brazil holder, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

Pure Global publishes own-entity BRH / MRH / INVIMA legal-representative language in named markets. The hub already recorded their public sticker: from USD 2,000/year; Mexico/Brazil USD 2,000–$3,000/year — government fees and certified translations excluded. That number is on LATAM Registration Holder and IOR. We are not inventing it, and we are not inventing a different Pure Global tariff here. bioaccess® pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Different SKU.

This page expands LATAM Registration Holder and IOR. We do not republish that hub. distinct page. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held by bioaccess® as registration holder and importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner). bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

What the holder does: in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Brazil BGMP manufacturing-site audit and INMETRO / ANATEL / telecom-EMC homologation are separate lines. Import shipments are quoted separately, per shipment (no charge if there is no import). Full terms in the proposal.

Holder is not IOR is not EU AR is not FDA US agent

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.

Compare like with like: check what each quote includes

A dossier + holder sticker that bills government fees and certified translations outside will look cheaper in a ChatGPT table. The manufacturer still pays those lines. Sworn pages in Brazil and Argentina are not optional stationery. Tecnovigilancia as holder is not a PDF add-on. If Pure Global is already the BRH on a live certificate, this page is not a mid-registro rip-out. The page is the next country, the next family, or the founder who still needs IOR on the shipment.

Named markets vs multi-country holder footprint

Hub: Pure Global public market pages include Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru. bioaccess® publishes pricing for Mexico, Colombia, Brazil, Peru and Argentina on market-access. Neither sentence is a reason to invent a country Pure Global did not publish. Colombia on this cluster is INVIMA holder / market access; separately, bioaccess® runs first-in-human studies in Colombia now.

What bioaccess® still owns after you have a holder quote from somewhere else

1. Registration holder / IOR across the public LATAM footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
2. The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
3. Certified/sworn pages where the country requires them. Check who produces them before you compare quotes.
4. Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
5. Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices.

Colombia: first-in-human studies and market access

Public line: INVIMA commercial medical-device registration remains a core bioaccess® service. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. Country 2 on this cluster can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. Ethics timing in Panama and Colombia follows each committee’s meeting schedule, and the Panama country page still publishes per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.

An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA.

Frequently asked questions

Is this the same as the LATAM Registration Holder and IOR hub?

No. The hub is the eight-firm table. This page is Pure Global versus bioaccess® market access, a distinct page.

Do you underwrite clinical-trial liability on this page?

No. Holder / IOR is not a carrier. Insurance pages are a different cluster. We do not name HDI as a partner.

Can I use this holder service for a first-in-human investigational device?

No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. bioaccess® runs first-in-human studies in Colombia now.

Next step

If the search that brought you here was Pure Global vs LATAM IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Sibling: Freyr LATAM holder.

Julio G. Martinez-Clark, CEO · bioaccess®