Author: Julio Martinez-Clark

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 No unpublished client.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

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

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

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

The card (do not invent another one)

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

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

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

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

Appointing a BRH is not being the BRH

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

Trial authorization is not commercial registro

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams. Do not put RDC 837 trial dossiers and commercial registro on one Gantt labeled “Brazil.” This page is the commercial holder. Investigational import is a different workstream. Clementino/UFRJ is not covered on this page.

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

The card (do not invent another one)

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

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

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

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

MRH vs distributor importer

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

Registro is not FIH start-up

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance. Keep trial clocks separate from registro sanitario. This SKU does not enroll patients. It holds the sanitary registration and can import the cleared device. bioaccess® runs first-in-human studies in Colombia now; the holder service is separate.

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

The card (do not invent another one)

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

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

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

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

What INVIMA holder actually is

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

Do not mix trial IOR into commercial holder

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

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

The card (do not invent another one)

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

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

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

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

Wide published country list is not the certificate

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

Market approval is not tecnovigilancia as holder

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

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

The card (do not invent another one)

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

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

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

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

Four published RH markets are not 19

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

Independent holder still has to answer IOR

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

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

The card (do not invent another one)

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

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

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

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

BRH support vs named on the certificate vs on the shipment

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

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

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

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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

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

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

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

The card (do not invent another one)

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

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

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

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

Compare like with like: check what each quote includes

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

Named markets vs multi-country holder footprint

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

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

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

Julio G. Martinez-Clark, CEO · bioaccess®

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; bioaccess® pricing is the two-part model on the rate card. 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 the LATAM Registration Holder and IOR hub; this cluster does not add a ninth Accel page. No PHI.

Emergo by UL is a global RA consultancy. The LATAM Registration Holder and IOR page (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 registration holder / IOR (own entity in Colombia; local partner elsewhere), with two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).

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

The card (do not invent another one)

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

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

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

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

What 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 the bioaccess® holder fee is not

The bioaccess® fee is not “more expensive Emergo.” It is a one-time registration fee, then an annual holder fee from year 2 for the holder role and 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 page.

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

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

Colombia: first-in-human studies and market access

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

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

Frequently asked questions

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

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

Do you underwrite clinical-trial liability on this page?

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

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

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

Next step

If the search that brought you here was Emergo vs a LATAM registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub: 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 page. 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 page. We do not split Israel and Canada into two posts until Julio asks.

This page is not a hospital site page and not an insurance page. distinct page. 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 pages. 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.

Country 2 is LATAM. It is not a second Australian CTN

Country 2 can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now. INVIMA registro remains a separate service.

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

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

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at Clinical Trials in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

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

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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 duplicate. Those operators have separate pages. This page is the geography pattern.

This page is not a hospital site page and not an insurance page. distinct page. 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 registry pull. 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 Australian campuses as the pitch

Site pages are a different topic. 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. 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

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. Colombia is an option too: bioaccess® runs first-in-human studies in Colombia now.

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

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

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

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

El Salvador is a public bioaccess® geography (DNM on llms.txt; live hub at Clinical Trials in El Salvador). We will not invent a new Salvadoran clock here.

Colombia: first-in-human studies and market access

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

A Bogotá hospital NCT row is facility evidence, not a CRO. If Colombia is country 2, bioaccess® runs first-in-human studies in Colombia now.

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. Published first-in-human device case studies 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 topics have their own pages. We do not underwrite. We do not name HDI as a partner here.

Can Colombia be country 2?

Yes. bioaccess® runs first-in-human studies in Colombia now. INVIMA registro is a separate service. 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®