Author: Julio Martinez-Clark

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 (CMS 95955), not Psicomed Antofagasta (CMS 95969), not Centro Vanguardia Temuco (CMS 95956), and not PUC Chile (skip). 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; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after batch 41 (CMS 95966–95973 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• 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 unioned.

Cite canonical ALL n=11 and DEVICE n=1. Do not clone Dermacross or PUC onto this slug.

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-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.

Do not smear the hospital

Clínica Las Condes is a serious named Santiago hospital on the public registry. ALL n=11 is registry volume, not a punchline. Do not invent a DEVICE n beyond 1. Do not invent a PI. PUC Chile stays skipped. 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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract 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 intercepts the search; it does not claim the studies.

Is this the same page as Dermacross or PUC Chile?

No. Clínica Dermacross is CMS 95955. PUC Chile stays skipped. 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 (CMS 95959), not Instituto Jalisciense (CMS 95971), not Universidad de Guadalajara (already live), and not Scientia Chihuahua (already live). 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; complete dump), this campus sits here after filters:

Counts come from leftover unique strings after batch 41 (CMS 95966–95973 live) plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

• 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 unioned): Arke SMO S.A. de C.V. ALL n=5; Arke SMO SA de CV ALL n=2.

Cite canonical ALL n=27 and DEVICE n=0. Do not invent a DEVICE n. Do not clone Instituto Veracruzano onto this slug.

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 typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. 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-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. 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.

Do not smear the hospital

Arké SMO is a serious named Veracruz research site on the public registry. ALL n=27 is registry volume, not a punchline. Do not invent a DEVICE n. Do not invent a PI. 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, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract 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 intercepts the search; it does not claim the studies.

Is this the same page as Instituto Veracruzano?

No. Instituto Veracruzano de Investigación Clínica is CMS 95959. 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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. 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. The locked bioaccess® card is still USD 7,500/year all-in for the first device family. Brazil Class III/IV at USD 12,000/year + INMETRO pass-through, and Class IIb Professional ~USD 15,000/year, are already on hub 95739 — not invented here. BGMP manufacturing-site audit (~USD 13,500/site) stays outside the flat fee as already published.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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® names own in-country entities on the certificate and puts sworn Portuguese pages inside the card. Ask which legal entity is the detentor and which entity imports.

Trial authorization is not commercial registro

Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams. 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. Do not mix leftover-site hospital FIH copy (Clementino/UFRJ stays skipped).

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

1. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

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

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. No PHI.

Mexico is a live holder market: ethics and trial clocks on clinical-trials-mexico are a different file from registro sanitario (~30 working days on that hub). This page is the commercial MRH / IOR intercept. Already-cleared devices. Locked card: USD 7,500/year all-in for the first device family. Mexico Class III / energy at USD 10,000/year is already published on the holder hub — not a rate we invent here.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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® own-entity 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-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. 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. Do not mix Magical BTK. Do not recommend Colombia for new FIH because a Mexico holder search went well — Colombia stays market access.

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

1. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

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

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. No PHI.

This is the Colombia holder page. It is market access. It is not a new first-in-human CTA. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. 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. The locked annual card is still USD 7,500/year all-in for the first device family.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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 slug. Named competitors stay on their own intercepts.

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. Leftover-site hospital intercepts stay off. Nanochon HOLD. Magical BTK off.

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

1. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

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

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. 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®’s locked card is USD 7,500/year all-in.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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. 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 what USD 7,500 is built to include, as already listed on the hub. 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. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

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

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. 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®’s locked card is USD 7,500/year all-in.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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 through own in-country entities and publishes IOR as 20% of CIF per shipment (USD 0 if no import) on the hub — not a rate we invent here. Ask MedEnvoy the same two-entity question: certificate vs shipment.

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

1. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

No. The hub is the eight-firm table and the SKU. This page is MedEnvoy independent RH versus the LATAM Launch Subscription. Distinct slug. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. 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®’s locked card remains USD 7,500/year all-in.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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 intercept 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. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

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

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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 except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. 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 CMS 95739. We are not inventing it, and we are not inventing a different Pure Global tariff here. bioaccess®’s locked card is USD 7,500/year all-in for the first device family. Different SKU.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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.

Do not compare excluded government fees to an all-in card

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 intercept is the next country, the next family, or the founder who still needs IOR on the shipment.

Named markets vs 19-market holder footprint

Hub: Pure Global public market pages include Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru. bioaccess® public footprint is 19 LATAM markets 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, not new FIH execution.

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

1. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

No. The hub is the eight-firm table and the SKU. This page is Pure Global sticker versus the all-in LATAM Launch Subscription. Distinct slug. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

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®

General information, not legal or regulatory advice. Confirm current COFEPRIS / ANVISA / INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. No unpublished client. Always bioaccess®.

If you searched Emergo vs LATAM registration holder, Emergo Mexico Registration Holder, Emergo Brazil BRH vs bioaccess, 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 hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. No PHI.

Emergo by UL is a global RA consultancy. The locked hub (CMS 95739, facts checked on public pages 2 September 2026) says Emergo publishes Independent Mexico Registration Holder and Brazil Registration Holder pages, and that distributors typically import without Emergo in the shipment. It does not publish an all-in LATAM subscription. That is not a smear. It is a different SKU. bioaccess® is the own-entity holder / IOR card at USD 7,500/year all-in.

This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.

The card (do not invent another one)

The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.

Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. 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 Emergo’s public LATAM holder pages are

Use the hub table, not a guessed rate card. Emergo’s public product is global RA (UL Solutions) plus independent MRH (Mexico) and BRH (Brazil) service pages. Resource-center language also covers in-country representative wording for Brazil, Mexico, Peru, Colombia, Costa Rica. “Independent holder” can still leave customs IOR with a distributor. If the search is “who is on my COFEPRIS or ANVISA certificate and who is on the import entry,” ask both questions. Do not assume the MRH is the shipment.

What USD 7,500 is not

USD 7,500 is not “more expensive Emergo.” The hub already said that. It is registration + holder + government submission fees + sworn/certified pages + tecnovigilancia as holder. We will not invent an Emergo annual fee. Empty cells on the hub stay empty. We do not add extra holder brands on this slug.

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

1. Own-entity holder / IOR across the public 19-market 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 inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
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. Do not mix Magical BTK. Do not sell insurance here.

Colombia stays market access on this cluster

Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and 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. Do not flip this intercept into leftover-site hospital FIH copy.

Frequently asked questions

Is this a clone of hub CMS 95739?

No. The hub is the eight-firm table and the SKU. This page is Emergo by UL versus the LATAM Launch Subscription. Distinct slug. We did not republish 95739.

Do you underwrite clinical-trial liability on this page?

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

Can I use this subscription 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. New FIH execution is not recommended in Colombia on the public line above.

Next step

If the search that brought you here was Emergo vs a LATAM registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub (do not clone): LATAM Registration Holder and IOR. Sibling: Pure Global vs LATAM IOR.

Julio G. Martinez-Clark, CEO · bioaccess®