Category: Preparing for First-In-Human Studies

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 No unpublished client.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®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Israel-only NCT device trial, Canada-only NCT medical device, second country Latin America FIH EFS, you were looking for a first-in-human / early-feasibility medical-device CRO in Israel or Canada. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

One page, two geography patterns, not a ninth slug. Device protocols that sit only in Israel, or only in Canada, still have a country-2 problem: the next n does not have to wait on another Helsinki or Health Canada cycle if Latin America can run ISO 14155 hospital implant or interventional ops. We cover both on this slug. We do not split Israel and Canada into two posts until Julio asks.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Israel or Canada if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

Israel-only is not Bioforum. Canada-only is not Avania and not JSS. Those brands have their own intercepts. This page is the NCT geography. We will not invent a named Israeli or Canadian device study here beyond what the locked CRO files already allowed on sibling pages. Remedy N1 at Unity Health Toronto is named on the Avania Canada page because Avania published it; we do not duplicate that case as if it were an NCT-only steal. JSS still has zero public device cases — we will not fill that gap here.

What country 2 is for an Israel-only protocol

A Ministry of Health Israel authorization does not import an investigational device into Panama or Brazil. Ethics language, ICF, and insurance exhibits have to be rebuilt for the Latin American committee. Bioforum’s published device-adjacent work is data / FDA package / 510(k) — not a reason to skip field-clinical. Pi-Cardia ShortCut is cleared; do not redo it. Next early protocol only.

What country 2 is for a Canada-only protocol

Health Canada CTA is not MINSA, ISP, ANVISA, or COFEPRIS. Unity Health is not a Latin American site. A Montréal MSA (JSS or otherwise) is not ISO 14155 in Santiago or Panama City. If Avania already ran country 1 in Toronto, keep them on country 1; add Latin America for the expansion. Do not rip a live protocol. Do not mix Magical BTK. Do not name HDI.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

Do not default country 2 to a new Colombian FIH. INVIMA registro remains. Use Panama, Chile, Brazil, Mexico, or El Salvador for new FIH execution on this cluster. Do not publish a ninth Israel-only hospital page or a ninth Canada-only hospital page from this brief.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

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.

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.

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.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

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™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Israel-only or Canada-only device NCT → LATAM as country 2, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Bioforum Israel, Avania Canada, JSS Canada.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Australia-only NCT medical device, second country Latin America FIH, CTN only device trial add LATAM, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

Some device protocols sit on ClinicalTrials.gov with Australia as the only country. That row is country 1. It is not a reason the next n has to wait on another CTN. Country 2 is Latin America: Panama, Chile, Brazil, Mexico, or El Salvador as the device needs. This page is not an Avania, Novotech, or GreenLight Clinical clone. Those operator intercepts are separate slugs. This intercept is the geography pattern.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

An Australia-only NCT location list is a snapshot, not a regulatory strategy. TGA/CTN does not import into MINSA, ISP, ANVISA, or COFEPRIS territory. A second Australian private hospital is not country 2. We will not scrape a new named sponsor list onto this page from CT.gov. We will not invent enrollment counts from a LATAM-only dump. If your protocol is already Australia-only, the operator question is whether the next amendment or the next protocol should add Latin America.

Do not use leftover Australian campuses as the pitch

Leftover-site FIH hospital pages are a different cluster and batch 42 stays waiting. Do not email an Australian NCT facility and ask them to become a Latin American site. Do not treat R&DTI as a substitute for ISO 14155 monitoring in Panama. Do not add NextLife. Nanochon stays HOLD.

Historic Alessa is not this page

NCT04284761 (Alessa Biolen-PC) listed Australia + New Zealand and later a US site; it is completed. Mentioned only as historic next-protocol context on the Avania AU page. It is not an Australia-only live steal and not a mail we send from here.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

Add country 2 before the protocol is frozen if the FDA-bridge story needs more n, more anatomy, or a backup geography when ANZ slots fill. Use the live clocks below. Do not default to a new Colombian FIH.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

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.

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.

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.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

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™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Australia-only device NCT → LATAM as country 2, start as the operator: contact bioaccess® or book from First-in-Human CRO. Operator CROs in this cluster: Avania, Novotech, GreenLight Clinical.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched JSS Medical Research Canada FIH CRO, JSS Montréal medical device trial, JSS LATAM device first-in-human, you were looking for a first-in-human / early-feasibility medical-device CRO in Canada. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

JSS Medical Research (Montréal HQ; Bogotá office via the 2013 LatAm Clinical Trials buy) sells Phase I–IV including medical devices and LATAM ops. That LATAM language is why device founders type the name. It is still not a public named FIH protocol. A capability sentence is not ISO 14155 hospital implant evidence. We will not pad this slug with an invented valve, embolic, or robot study just to look even with Avania’s Remedy N1 keeper. Locked 28 Aug and 1 Sep 2026: no case-study / success-story pages and no named device protocol found. Empty device cases stay empty. We will not invent a named device study to fill this slug.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Canada if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

The search is still real. Canadian device founders type JSS because the shop already speaks LATAM. A Bogotá office is not a reason to book a new INVIMA FIH from this cluster. Country 2 for new FIH execution is Panama, Chile, Brazil, Mexico, or El Salvador. Colombia stays INVIMA registro / market access.

What the public site does not give us

Service copy is not a protocol. Logo walls without a device FIH/EFS case are not stealable rows. We will not borrow Avania’s Remedy N1 onto JSS. We will not borrow Pi-Cardia onto JSS. We will not add extra CRO brands.

Watch, do not fabricate

If JSS later publishes a named device FIH/EFS, that is a monthly refresh. Until then this page intercepts the query and sends the founder to an operator who actually runs hospital implant FIH in Latin America. Do not treat a Montréal MSA as ISO 14155 in Panama.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

Canada-only NCT geography shares a page with Israel-only — not a ninth slug. JSS-the-brand is this slug.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

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.

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.

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.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

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™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was JSS Medical Research Canada as the FIH CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Avania Canada, Israel- or Canada-only NCT.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Bioforum Israel FIH device CRO, Bioforum medical device first-in-human, Bioforum Pi-Cardia LATAM, you were looking for a first-in-human / early-feasibility medical-device CRO in Israel. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

Bioforum is on the named AU/IL/CA set because it is a data-focused CRO with a Melbourne office and an Israel base. Locked device-adjacent cases are biometrics, not bioaccess®-style hospital FIH ops. Pi-Cardia ShortCut™ (leaflet-modification for valve-in-valve TAVR) is named, FDA-cleared, Breakthrough Device; Bioforum’s published role is data / stats / FDA package; EU → US site expansion on that page; not an Australia ops case. ShortCut itself is cleared — do not pitch a redo. Steal is Pi-Cardia’s next leaflet / valve-in-valve / next-gen EFS operations in LATAM if that protocol exists. We will not invent it onto this page as if it were already signed.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Israel if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

Ibex Prostate Detect is a named AI/SaMD 510(k) client (stats + data management + site monitoring on Bioforum’s congratulations page; Ibex also notes TGA and ANVISA registrations on its own clearance copy). Already cleared. Steal would be a LATAM clinical-performance / next-indication study, and only if that study is a true early device protocol — not a 510(k) follow-on we pad into a five-trial goal. MeMed BV® on MeMed Key® is a named host-response IVD (FDA 510(k) Sep 2021); Bioforum role is EDC + CEC + CSR. Country of APOLLO sites is not stated on the Bioforum page. Asset already cleared.

What is excluded on purpose

Abiomed Impella post-approval data partnership (from Jun 2019; PAS figures are Abiomed’s published numbers, not a Bioforum FIH). Dren Bio DR-01 is a drug EDC case. Neither is an Israel hospital-implant FIH we can steal. We will not add extra CRO brands. We will not name NextLife.

Israel-only NCT rows are the sibling page

This intercept is the Bioforum operator. Israel-only or Canada-only device NCT geography is the combined second-country page — one page, not a ninth. Do not split it.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

A data CRO package does not import an investigational implant into Panama. If the next protocol needs ISO 14155 field-clinical in Latin America, that is a different operator. Country 2 is not a new Colombian FIH CTA.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

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.

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.

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.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

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™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Bioforum Israel as the FIH device CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Sibling NCT page: Israel- or Canada-only NCT → LATAM.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched GreenLight Clinical Australia FIH CRO, GreenLight Clinical Sydney medical device, GreenLight Clinical first-in-human, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

GreenLight Clinical is the Sydney CRO. This page is never Greenlight Guru, never Christine, never an EDC SKU. Locked 28 Aug and 1 Sep 2026: the therapeutic-areas page claims medical-device + FIH experience. The homepage names Surface Ophthalmics (C-100-001 / C-200-001) — ophthalmic drug (SURF-100/200). No named device case study and no sponsor+device URL was found. Capability copy is not a stealable hospital-implant FIH.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

Device founders land here because “GreenLight” + “Australia” + “FIH” is a crowded query. If you meant the eQMS/EDC vendor, you are on the wrong site and we will not route you there. If you meant the Sydney CRO for a device EFS, there is no public named device protocol to steal from. The intercept is still country 2: Latin America for the protocol that capability copy cannot show.

Named client on the public site is drug

Surface Ophthalmics is not an implant EFS. We will not recast SURF-100/200 as a device. We will not invent a GreenLight Clinical neurovascular or structural-heart case. We will not scrape Guru Clinical customer stories (Loop Medical, InnoCon, Medartis) onto this AU CRO page — those are not AU/IL/CA FIH steal targets for this job.

Do not merge Avania, Novotech, and GreenLight Clinical

Avania publishes unnamed AU device FIH cases. Novotech publishes drug FIH cases. GreenLight Clinical publishes capability plus a named drug client. Three slugs. Three jobs. Do not write a mega-CRO smear. Do not add extra brands.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

A Sydney capability page is not MINSA clearance and not ISO 14155 monitoring in Panama. If the device still needs first human data that can travel toward an FDA IDE, use the live LATAM hubs. Do not wait for a GreenLight device case study to appear.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

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.

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.

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.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

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™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was GreenLight Clinical Australia as the FIH CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Novotech AU, Avania AU.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current ethics and national-file rules with qualified advisers. We do not invent clocks, rates, or named studies that are not on the locked public sources cited here. No patient data. No unpublished client. Always bioaccess®.

If you searched Novotech Australia FIH CRO, Novotech first-in-human medical device Australia, Novotech Sydney device EFS, you were looking for a first-in-human / early-feasibility medical-device CRO in Australia. Competitor watch on this cluster is the named AU/IL/CA FIH CRO set only: Avania, Novotech, GreenLight Clinical, Bioforum, JSS Medical Research. We do not invent extra CRO brands. We do not invent extra named sponsors. We do not sell insurance. We do not name a carrier as a signed partner. Nanochon stays HOLD. NextLife is not a new steal. Magical BTK stays off this page. No PHI.

Novotech is a Sydney-founded regional mega-CRO. Device sponsors type the name because Australia-as-country-1 is a slide they have already seen. Honest hedge, locked on 28 Aug 2026 and re-checked 1 Sep 2026: Novotech’s public case-study hub is drug FIH. 2026 pages include a complex GMO oncology trial (AU + US, FPFD 2 Dec 2025), FIH mRNA immunotherapy across APAC, and Phase I/II oncology start-up in Australia for a China biotech (May 2026). Older DiaMedica Phase I is drug. No device case study was found on the hub. This page still exists because the search is real. We will not invent a Novotech device FIH to fill the gap.

This page is not a leftover-site hospital intercept and not an insurance intercept. Distinct slug. Distinct title. The job is country 2: keep Australia if it is already running, add Latin America for the next protocol, the expansion, or the backup geography. Eligibility of foreign data under 21 CFR 812.28 is not FDA clearance. See OUS FIH and FDA IDE.

What this search is actually buying

If you are a drug sponsor, this is the wrong operator. If you are a device sponsor who Googled Novotech because CTN + R&DTI is the Australia story, country 2 is a Latin American hospital-implant stack, not a second Novotech work order we invent. Do not count GMO, mRNA, or DiaMedica toward a device five-trial goal.

What we will not do with Novotech’s named drug FIHs

ReveraGen, PharmAbcine, DiaMedica, Botanix and other names that appear on drug case pages are not medical-device EFS. We will not re-skin them as implants. We will not imply Novotech ran an unnamed stent, valve, or liquid embolic in Australia. If a future public Novotech page names a true device FIH/EFS, that is a later refresh — not this intercept.

Why a device founder still uses this search

Australia-first is sold on speed and incentives. A device still needs ISO 14155, implant or interventional sites, import, and a 21 CFR 812.28 story. A mega-CRO drug Phase I unit is not that. GreenLight Clinical is a different AU CRO intercept. Avania is the AU shop actually publishing device FIH cases. Do not merge the three brands.

Country 2 is LATAM. It is not a second Australian CTN, and it is not a new Colombian FIH CTA

Keep Australia if it is already running. Add Panama, Chile, Brazil, Mexico, or El Salvador for the n that will not wait on another CTN. Do not default to a new Colombian FIH.

Use clinical-trials-panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance.

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.

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.

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.

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at clinical-trials-el-salvador). We will not invent a new Salvadoran clock here.

Colombia stays market access

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™.

Historic Colombia FIH on public bioaccess® pages is not a reason to book a new INVIMA FIH from this cluster. Do not treat a Bogotá hospital NCT row as country 2.

What bioaccess® still owns on the steal

1. ISO 14155 field-clinical, not a Phase I unit brochure. Hospital implant and interventional sites in Panama, Chile, Brazil, Mexico, El Salvador as the device needs.
2. Protocol, IB, ICF, ethics / national file in the same stack. A hallway conversation at an Australian private hospital is not that file.
3. Importer of record and device accountability. See importer of record for clinical trial devices in Latin America. A CTN or Health Canada CTA does not import the investigational product into Latin America.
4. 21 CFR 812.28 narrative if the next stop is an FDA IDE. Eligibility of foreign data is not a guarantee of clearance.
5. No AU / IL / CA legal entity required to start country 2. Do not wait on R&DTI, a second CTN, or a Toronto MSA to generate the next n.

The firm was founded in 2010. Public device case studies already on llms.txt (ReGelTec, Axoft, Newrotex, enVVeno, Avantec Vascular / Sangria™ as published) show FIH execution. We will not invent a new named client onto this page.

Frequently asked questions

Is bioaccess® trying to replace the incumbent CRO on a live protocol?

No. If Avania, Novotech, GreenLight Clinical, Bioforum, or JSS is already running country 1, the steal is the next protocol, the expansion, or a LATAM satellite — not a mid-study rip-out we invent.

Do you sell clinical trial insurance on this page?

No. We are the FIH CRO. Insurance intercepts live on their own slugs. We do not underwrite. We do not name HDI as a partner here.

Is Colombia the country-2 default?

No. New FIH execution is not the Colombia CTA on this cluster. INVIMA registro remains. See the Colombia paragraph above.

Next step

If the search that brought you here was Novotech Australia as the FIH CRO, start as the operator: contact bioaccess® or book from First-in-Human CRO. Siblings: Avania AU, GreenLight Clinical AU.

Julio G. Martinez-Clark, CEO · bioaccess®