El registro sanitario de un dispositivo médico en América Latina no es un trámite de aduana ni un contrato de distribución. Es un acto administrativo: la autoridad sanitaria emite un certificado a nombre de una persona jurídica en el país. Esa persona es el titular (o detentor, o registration holder). En varios mercados esa misma persona — o una licencia pegada a ella — es también el importador de registro. Si el titular es su distribuidor, el registro es palanca comercial. Si el titular es un especialista independiente, usted puede cambiar de canal sin rehacer el expediente… siempre que el contrato prevea la cesión.

Esta página es un hub de categoría, no un ataque a un competidor. Explica la diferencia entre titular e importador/distribuidor, nombra las autoridades que bioaccess® publica, y apunta al producto correcto: la LATAM Launch Subscription. Siempre bioaccess®. No hay clientes inventados, ni correos, ni listas de países que no estén en las páginas públicas de bioaccessla.com.

Titular vs. distribuidor: la pregunta que evita el secuestro del registro

El fabricante extranjero casi nunca puede figurar solo en el certificado. Cada regulador ata el registro a una entidad local:

• Titular / detentor / registration holder. Es el nombre en el registro. Responde ante la autoridad por el expediente, las modificaciones y, en la práctica, por buena parte de la vigilancia post-comercialización.
• Importador de registro (IOR). Es quien puede nacionalizar el producto. En algunos países el titular puede autorizar varios importadores sobre el mismo registro. En otros, titular e importador son la misma persona y no hay segundo IOR.
• Distribuidor comercial. Vende, factura, da servicio. No tiene por qué ser el titular. Cuando lo es, cambiar de canal implica una cesión formal — o un registro nuevo.

La doctrina correcta, y la que bioaccess® opera, es: el titular es un especialista independiente, con entidad propia, y el contrato trae una ruta de transferencia. El registro no es rehén. Las reglas por país — multi-importador frente a IOR único — están en la guía Importer of Record en LATAM.

Ejemplos públicos de esa geometría (no es una lista inventada; es el mapa ya publicado):

• México (COFEPRIS), Colombia (INVIMA), Brasil (ANVISA). Un titular puede articular varios importadores sobre un mismo registro, con matices de cada norma.
• Argentina (ANMAT). El representante / titular es, en la práctica, el único importador de ese registro.
• Perú (DIGEMID). Importación a través de droguería licenciada; el titular independiente es posible bajo el marco vigente citado en la guía IOR.

Si un “socio local” le ofrece “yo registro y yo vendo,” pida por escrito: (1) razón social que figurará como titular, (2) si esa sociedad es suya o de un tercero, (3) cómo se cede el registro si termina el contrato, (4) quién paga tasas gubernamentales y traducciones certificadas.

Qué incluye el registro — y qué suele facturarse aparte

Un expediente de dispositivo ya autorizado por FDA (510(k)/PMA) o con marcado CE no se “copia y pega” en Latinoamérica. Hay vía de equivalencia o reliance en algunos mercados (por ejemplo, la vía abreviada de COFEPRIS cuando el dispositivo es del mismo fabricante y ya está aprobado y comercializado en un país de referencia). Hay notificación frente a registro en ANVISA según clase. Hay registro automático frente a revisión previa en INVIMA según clase. Esos relojes son de la agencia. El trabajo del titular es el expediente, el idioma, las tasas y la representación.

Tres partidas que los consultores globales suelen dejar fuera del honorario y que bioaccess® mete en la suscripción anual por país y familia de dispositivo:

• Tasas gubernamentales de presentación.
• Traducción certificada (y jurada donde aplica, Brasil y Argentina) de IFU, etiquetas y expediente técnico — en casa, no como markup de una agencia.
• Agente / titular local y la gestión de la sumisión.

La tarifa específica de bioaccess® está en revisión — solicite una cotización. El hub publica descuentos multi-país y el Trial-to-Market Bridge para clientes de ensayo clínico. Fuera de cualquier tarifa plana honesta quedan la auditoría BGMP de planta en Brasil y la homologación telecom/EMC-RF de dispositivos inalámbricos; se gestionan y se facturan a costo de proveedor más G&A publicado. Detalle: bioaccessla.com/market-access.

Autoridades que bioaccess® nombra en público

Seis mercados núcleo, con página propia o bloque en el hub: Brasil (ANVISA), Colombia (INVIMA), México (COFEPRIS), Argentina (ANMAT), Chile (ISP), Perú (DIGEMID). La misma página de market access nombra también MINSA (Panamá), ARCSA (Ecuador), DNM/SRS (El Salvador) y DIGEMAPS (República Dominicana), y describe cobertura en 19 mercados de LATAM (lista completa a solicitud). No se añaden países aquí que no estén en esas páginas.

• Registro ANVISA — Brasil
• Registro COFEPRIS — México
• Registro INVIMA — Colombia
• Registro ANMAT — Argentina
• Registro ISP — Chile

bioaccess® no obtiene el 510(k), el PMA ni el marcado CE por usted. El producto es el registro sanitario en LATAM de un dispositivo ya autorizado en esos marcos de referencia, más la tenencia del certificado a través de entidades propias.

Garantía de sumisión, no garantía de aprobación

La autoridad controla el dictamen. bioaccess® controla su trabajo: expediente completo presentado, en español o portugués certificado, con tasas pagadas, en la fecha comprometida. Si falla lo que controla, acredita una porción de la tarifa anual de ese país. Términos completos en la propuesta. Eso es la Submission Guarantee. No es una promesa de que COFEPRIS, ANVISA o INVIMA aprueben.

Cómo elegir titular sin confundirlo con la CRO

El ensayo clínico first-in-human y el registro comercial son actos distintos. Se puede — y suele — usar el mismo socio de confianza para no reaprender el expediente, y eso es el Trial-to-Market Bridge de bioaccess®. No contrate un titular de registro como si fuera la CRO del implante, ni una CRO de fase III de fármaco como si fuera su detentor ANVISA. Producto distinto, contrato distinto, a veces la misma firma.

1. Pida la razón social local que firmará como titular en cada país.
2. Pida si esa sociedad es propia o una red de partners.
3. Pida la cláusula de cesión.
4. Pida la lista de inclusiones: tasas, traducción jurada, respuestas a requerimientos, renovación.
5. Pida el remedio si el vendor atrasa la sumisión que él controla.

Preguntas frecuentes — registro sanitario de dispositivos médicos en LATAM

¿Qué es el titular de un registro sanitario?

La persona jurídica local a cuyo nombre la autoridad emite el certificado. No es, por definición, el distribuidor.

¿Puedo usar mi distribuidor como titular?

En muchos mercados es legal. Es una mala arquitectura si usted quiere cambiar de canal. Prefiera un titular independiente con cesión definida.

¿bioaccess® es el titular en Latinoamérica?

bioaccess® registra y sostiene el dispositivo a través de sus propias entidades locales, con disposiciones de transferencia en el acuerdo. Cobertura descrita como 19 mercados; detalle en el hub de market access.

¿Cuánto cuesta?

Suscripción anual plana por país y familia de dispositivo. Las tarifas específicas están en revisión — solicite una cotización. Tasas gubernamentales y traducciones certificadas van incluidas.

¿Dónde empiezo?

Market access, IOR, contacto o agenda.

Hechos de bioaccess®: bioaccessla.com/market-access y bioaccessla.com/latam-importer-of-record (revisión julio 2026). Página de categoría, no comparativo de un competidor nombrado. Sin clientes, correos, estadísticas ni países inventados. Consultado 23 de agosto de 2026.

Freyr Solutions publishes a dedicated “medical device registration in LATAM” hub. That page is why this article exists. A manufacturer searching “LATAM device registration” or “Brazil Registration Holder” will see Freyr and bioaccess® in the same cluster. Freyr is a global regulatory-affairs firm with a LATAM device offering. bioaccess® is the LATAM holder subscription. Both can be on an RFP. They should not be scored as the same SKU.

Tone first: Freyr is a legitimate global RA shop. If you need a worldwide dossier machine and you already buy Freyr for other regions, keep them. If you need an in-country titular who includes government fees and certified translations in one annual fee, holds through own entities, and will still be there if the next milestone is a LATAM trial, that is bioaccess®.

What Freyr publishes about LATAM devices

The LATAM registration page is freyrsolutions.com/medical-devices/medical-device-registration-in-latam. It states a “strong presence in Brazil, Mexico, and Colombia.” The medical-device market-access hub lists Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), and Colombia (INVIMA). Country microsites exist at freyrsolutions.com.br and freyrsolutions.com.mx. Those are the public geography claims used here. No extra countries are added.

The Brazil Registration Holder page is the sentence that matters for this comparison. Freyr writes that it acts as the BRH — liaison / agent language, “Act as the BRH” — and that it has an extensive partner network across Brazil. Read both halves. “We act as BRH” is a holder claim. “Partner network across Brazil” is a network claim. A manufacturer should ask, in writing, which local CNPJ will be the detentor de registro on this file, and whether that company is Freyr-owned or a partner. Transfers in Brazil require the current holder’s cooperation; Freyr’s own materials warn that changing BRH is not a casual email.

The Mexico language on the public medical-device pages is coordination with the registration holder and the local legal representative. That is not the same sentence as “Freyr is your Mexico Registration Holder.” Treat Mexico as RA coordination unless a signed SOW names Freyr (or a named Freyr Mexico entity) as titular. Argentina is listed on the market-access hub as ANMAT; that is a listed market, not automatically a published AAR-owned-entity claim.

Commercial model, as published: “cost-effective annual support for BRH Service.” That is annual holder support, not an all-in government-fee-plus-certified-translation subscription. “Approved translation” appears as a challenge on Freyr’s LATAM materials, not as an included in-house factory. The marketing KPI “99%+ first-time-right” is a quality statistic. It is not a fee-credit guarantee if the vendor misses a submission date it controls. No Trial-to-Market Bridge (LATAM FIH CRO + commercial registration) is published. Facts from Freyr’s public medical-device pages, retrieved 23 August 2026. No clients or emails added.

BRH is a legal person, not a slide

ANVISA issues the registro or notificação to a detentor de registro. That company is on the hook for post-market obligations and for authorizing importadores (RDC 751/2022; importers can be added without re-registering the device under the rules summarized on the IOR guide). If the detentor is a partner in a network, you have a competent local face and a second contract to unwind later. If the detentor is the vendor’s own Brazilian company, you have one throat to choke and a cleaner transfer covenant — provided the covenant is actually in the agreement.

bioaccess® holds LATAM registrations through its own in-country entities for the manufacturer’s benefit, with defined transfer provisions so the file is not leverage. Brazil is one of the six core markets detailed on the ANVISA country page. The LATAM Launch Subscription puts government submission fees and certified Portuguese (sworn where required) inside the annual fee. Brazil BGMP site audit remains outside any honest flat fee and is billed at vendor cost plus published G&A — that carve-out is on the hub, not hidden.

Freyr vs bioaccess®

Dimension	Freyr Solutions (public)	bioaccess®
Product	Global RA / market access; LATAM device-registration hub; annual BRH support	LATAM Launch Subscription: sanitary registration + holder / IOR
Public LATAM footprint	“Strong presence” BR / MX / CO; hub lists ANVISA, COFEPRIS, ANMAT, INVIMA	19-market coverage; hub details BR, CO, MX, AR, CL, PE and names MINSA, ARCSA, DNM, DIGEMAPS
Brazil Registration Holder	Freyr acts as BRH and cites a partner network across Brazil — ask which model applies to your CNPJ	Own-entity holder; transfer provisions in the agreement
Mexico	Public language: coordination with the registration holder / local legal representative	bioaccess® as independent titular / IOR on the COFEPRIS workstream
Bundle	Annual BRH support; gov fees + certified translations not published as one all-in family fee	Government submission fees + certified translations included
Translation	Listed as a challenge (“approved translation”), not as included in-house production	In-house; sworn where required; manufacturer owns the translation memory
Guarantee language	“99%+ first-time-right” = marketing KPI, not a fee-credit remedy	Submission Guarantee: we credit a portion of that country’s annual fee if we miss the submission workmanship we control (full terms in the proposal)
Pricing	Project / line-item plus annual BRH support; no public all-in LATAM subscription	Flat annual subscription per country / device family; rates under review — contact for a quote
Trial-to-Market Bridge	Global RA, not a published LATAM FIH CRO	Same partner from LATAM trial to commercial registration

When Freyr is the better fit

• You want a global RA firm for a worldwide submission calendar, and LATAM is one region on that calendar.
• You specifically want Freyr’s BRH annual-support product and you have confirmed, in writing, whether the detentor is Freyr or a partner.
• You will buy translations and government fees as separate lines and you are comfortable with a first-time-right KPI instead of a fee-credit clause.
• Your live LATAM set is the BR / MX / CO presence (plus ANMAT as listed) and you do not need the rest of the 19-market holder map on day one.

When the LATAM Launch Subscription is the better fit

• The buying criterion is “who is on the certificate,” not “who can coordinate a holder.”
• You want government fees and certified translations inside the annual fee.
• You want a Submission Guarantee that can credit fee, not only a 99%+ statistic.
• You need holder / IOR beyond the four regulators Freyr lists, or you need the multi-importer vs single-IoR map.
• You want the Trial-to-Market Bridge.

Read market access, IOR, Brazil, Mexico, Colombia, Argentina. Compares already published: vs Emergo by UL, vs Qserve.

What to ask Freyr (and any global RA shop) before you sign a BRH

1. Name the Brazilian company that will be the detentor. Employee count in São Paulo is not the answer.
2. Is that company Freyr-owned or a partner? Who signs the transfer if we leave?
3. On Mexico: will Freyr be the titular, or will Freyr coordinate a third-party holder?
4. Are ANMAT filings done as AAR, or is Argentina a project-management line?
5. Itemize government fees and sworn translations. If they are extra, put them in the comparison total.
6. What happens commercially if a first-time-right miss is the vendor’s workmanship? A KPI slide is not a credit.

bioaccess® pricing stays under review — contact for a quote. Do not treat typical-competitor ranges on the hub as a Freyr quote; they are category context, not this firm’s invoice.

FAQ — Freyr LATAM / BRH

Does Freyr register medical devices in LATAM?

Yes, on its dedicated LATAM device-registration page. It claims a strong presence in Brazil, Mexico, and Colombia and lists ANVISA, COFEPRIS, ANMAT, and INVIMA on the market-access hub.

Does Freyr act as Brazil Registration Holder?

The BRH page says Freyr acts as the BRH and also cites a partner network across Brazil. Confirm which model applies to your registration.

Is Freyr the Mexico Registration Holder on the public page?

The public Mexico language reviewed here is coordination with the holder and local legal representative. Do not assume Freyr is the titular until the SOW says so.

Is “99%+ first-time-right” a Submission Guarantee?

No. It is a marketing KPI. bioaccess®’s Submission Guarantee is a workmanship remedy that can credit a portion of that country’s annual fee. Full terms in the proposal. Neither firm can guarantee agency approval.

Is this a smear of Freyr?

No. Freyr is a global RA firm. The distinction is product: annual BRH support and LATAM coordination versus a LATAM-only all-in holder subscription.

Where should a sponsor start?

Market access, IOR, contact.

Sources for competitor facts: freyrsolutions.com medical-device LATAM, market-access, and Brazil Registration Holder pages (plus .br / .mx medical-device microsites), retrieved 23 August 2026. bioaccess® facts: bioaccessla.com/market-access and bioaccessla.com/latam-importer-of-record. No invented clients, emails, statistics, or country lists.

“Mexico Registration Holder” is a job title, not a brand. When a manufacturer types that string, MedEnvoy and bioaccess® are both allowed to appear. MedEnvoy is a specialist in-country representative (ICR) firm. bioaccess® is the LATAM holder subscription. They overlap in Mexico, Colombia, Peru, and Brazil. They do not overlap as products.

This page names MedEnvoy from its public site, then maps the rest of Latin America. MedEnvoy is a reasonable independent holder in the four LATAM markets it actually publishes. It is not, on the public record, an all-in 19-market subscription with government fees and certified translations inside one annual fee. That is the bioaccess® job.

What MedEnvoy publishes about itself

MedEnvoy’s site is medenvoyglobal.com. The firm presents as a global in-country representation specialist, founded in the Netherlands, independent of distributors. The homepage service picker and the in-country-representation section list four LATAM products by name: Mexico Registration Holder, Colombian Registration Holder, Peru Registration Holder, and Brazil Registration Holder. Dedicated pages exist for those four:

• Mexico Registration Holder — “MedEnvoy is your trusted Mexico Registration Holder.”
• Brazil / ANVISA
• Colombia / INVIMA
• Peru / DIGEMID

Argentina appears in translation-related content, not as a published Argentina Authorized Representative product page on the pages reviewed 23 August 2026. We do not invent an AAR service MedEnvoy has not posted.

Independence from distributors is the core pitch, especially on the Mexico page: the manufacturer keeps the sanitary registration and can appoint or change commercial partners without handing them the titular role. That is the correct doctrine. Transfer of a COFEPRIS registration is still a formal process; MedEnvoy says so. The Brazil, Colombia, and Peru pages explain the legal role and invite coordination. They do not, on those pages, quote a named local CNPJ or RFC. ISO 13485 is claimed for the firm on the public about / quality language.

Pricing is quote-driven. There is no public all-in LATAM Launch-style subscription that includes government fees and sworn translations in one annual number. Translations show up as a compliance topic (including blog treatment), not as an in-house factory bundled into the holder fee. No Submission Guarantee equivalent and no trial-to-commercial LATAM CRO bridge appear on the public pages reviewed. Facts above are from MedEnvoy’s public site, 23 August 2026. No clients or emails are added.

Mexico is not “the rest of LATAM”

COFEPRIS is the query that pays for a lot of ICR marketing, and for good reason. Mexico is a large device market, the equivalence route (vía abreviada) is real for devices already approved and marketed by the same manufacturer in a reference country, and the Mexico Registration Holder can name multiple distributors and importers on one sanitary registration. That last point is why an independent MRH is worth buying: you can add a second importer without restarting the file. See the country rules on the LATAM Importer of Record guide and the COFEPRIS country page.

The mistake is to treat a four-country ICR menu as a Latin American operating system. A manufacturer that clears Mexico still has to answer, country by country:

• Who is the titular in Colombia (INVIMA — a titular can have several importers)?
• Who is the detentor de registro in Brazil, and who are the authorized importadores?
• Who is the fused holder-and-importer in Argentina (ANMAT — one AAR per registration)?
• Who holds Chile (ISP), Peru (DIGEMID / droguería rules), Panama (MINSA), Ecuador (ARCSA), El Salvador (SRS), Dominican Republic (DIGEMAPS), and the other markets on a 19-country plan?

MedEnvoy publishes holder pages for MX, CO, PE, and BR. That is a real four-market ICR product. It is not a published ANMAT, ISP, MINSA, ARCSA, DNM/SRS, or DIGEMAPS holder product. bioaccess® publishes the LATAM Launch Subscription as coverage across 19 LATAM markets, with six core markets detailed on the hub and those additional regulators named on the same page. Own in-country entities hold the files, with defined transfer provisions so the registration is not hostage.

MedEnvoy vs bioaccess® — same contrast axes

Dimension	MedEnvoy (public)	bioaccess®
Product	Global ICR / registration-holder specialist; independent of distributors	LATAM Launch Subscription: register + hold already-cleared devices
Public LATAM holder pages	Four: Mexico, Colombia, Peru, Brazil	19-market coverage; hub details BR, CO, MX, AR, CL, PE; also names MINSA, ARCSA, DNM, DIGEMAPS
Independence / anti-leverage	Core pitch — do not let the distributor hold the registration	Same doctrine, plus own entities and written transfer provisions
Bundle (gov fees + certified translations)	Not published as an all-in annual inclusion	Included in the annual subscription per country / device family
In-house translation	Discussed as compliance / blog topic, not as included production	In-house certified Spanish/Portuguese; sworn where required; translation memory is the manufacturer’s property
Pricing model	Quote-driven; no public all-in LATAM subscription	Flat annual subscription; rates under review — contact for a quote. Multi-country and Trial-to-Market Bridge discounts as published on the hub
Quality claim	ISO 13485 claimed	Operating model published on the market-access hub (track record is self-reported as of July 2026)
Submission Guarantee	None found on the public pages reviewed	Submission workmanship: dossier in, certified language, government fees paid, on the committed schedule, or a portion of that country’s annual fee is credited (full terms in the proposal)
Trial-to-Market Bridge	Not a LATAM FIH CRO	Same partner from trial to commercial registro sanitario

When MedEnvoy is the better fit

• You want a dedicated global ICR, not a LATAM-only subscription, and Mexico / Brazil / Colombia / Peru is the live set.
• Independence from distributors is the only buying criterion and you will run translations and government fees as separate vendors.
• You already use MedEnvoy as ICR in other regions and want one representative brand on the org chart.
• You need ISO 13485 language on the ICR itself and you are buying a quote, not a published bundle.

Hire them for that. Do not hire them for a job they have not published — for example, “titular in 19 LATAM markets with sworn translations inside one fee.”

When bioaccess® is the better fit

• Mexico is the first country, but Argentina, Chile, Panama, Ecuador, El Salvador, or the Dominican Republic is already on the 12-month plan.
• You want government fees and certified translations inside the annual fee.
• You want the holder to be bioaccess®’s own local entity, with transfer language, including the IOR variants (multi-importer vs single-IoR) documented on the IOR guide.
• You want a Submission Guarantee on submission workmanship.
• You want the Trial-to-Market Bridge — the same firm that can run the LATAM trial can hold the commercial file.

Start at the market-access hub. Country deep-dives: Mexico, Brazil, Colombia, Argentina, Chile. Existing global compares: vs Emergo by UL, vs Qserve.

Questions to put in the MedEnvoy (or any ICR) RFP

1. Name the local legal entity that will be the COFEPRIS / INVIMA / ANVISA / DIGEMID holder. Is it MedEnvoy-owned or a partner?
2. Which LATAM countries beyond MX / CO / PE / BR are in scope on a written SOW — and which are “we can introduce someone”?
3. Are government fees and sworn translations included, estimated, or excluded?
4. What is the transfer covenant if we change ICR or stand up our own entity?
5. Who owns the translation memory?
6. Is there a fee-credit remedy if the vendor misses a submission date it controls?

bioaccess® answers those from the published subscription. Pricing is under review — contact for a quote.

FAQ — MedEnvoy Mexico Registration Holder / LATAM

Is MedEnvoy a Mexico Registration Holder?

Yes, on its own public page. It sells an independent MRH, separate from the distributor.

Which other LATAM holder pages does MedEnvoy publish?

Colombia (INVIMA), Peru (DIGEMID), and Brazil (ANVISA). Four public LATAM markets. Argentina is not treated here as a published AAR product page.

Does MedEnvoy publish an all-in LATAM subscription?

No. Pricing is quote-driven on the public record reviewed 23 August 2026.

Does ISO 13485 make MedEnvoy the LATAM holder?

It is a quality claim for the firm. It is not a substitute for own-entity coverage, included government fees, or a transfer covenant.

Is this a smear?

No. MedEnvoy is a specialist ICR. The distinction is product: four published LATAM holder pages and a quote, versus a 19-market LATAM subscription with translations and government fees in.

Where should a sponsor start?

Market access, IOR guide, contact.

Sources for competitor facts: medenvoyglobal.com (homepage, about, ICR hub, MX / BR / CO / PE holder pages), retrieved 23 August 2026. bioaccess® facts: bioaccessla.com/market-access and bioaccessla.com/latam-importer-of-record. No invented clients, emails, statistics, or country lists.

When a U.S. or EU medtech team searches “flat-fee medical device registration,” “ANVISA license holder,” or “COFEPRIS Mexico Registration Holder,” Pure Global and bioaccess® can land on the same shortlist. That is not an accident. Both firms sell an independent in-country holder for already-cleared devices, and both talk about an annual fee instead of a one-off consulting SOW.

They are still different products. Pure Global is a global market-access firm with a published flat annual fee that starts at USD $2,000 per year and, on its own 5 February 2026 press release, leaves government fees, certified translations, and marketing materials outside that fee. bioaccess® is the LATAM holder subscription: sanitary registration, own-entity holder / importer of record, certified translations, and government submission fees inside one annual fee per country and device family, with a Submission Guarantee and a Trial-to-Market Bridge for clinical-trial clients. This page is a practitioner comparison, not a smear. Pure Global is a reasonable global RA / holder option in the markets it actually names. bioaccess® is the LATAM-only holder subscription.

What Pure Global publishes about itself

Pure Global’s public site is pureglobal.com. The firm positions local companies as authorized representative / license holder and publishes dedicated market pages for Argentina, Brazil, Colombia, Costa Rica, Mexico, and Peru (plus North America). On the Brazil, Mexico, and Colombia pages it sells the classic holder roles: Brazilian Registration Holder (BRH), Mexico Registration Holder (MRH), and INVIMA Legal Representative (with CCAA importer language on the Colombia page).

Public entity language is strongest in those three markets. Pure Global names its own local companies in Brazil, Mexico, and Colombia — including Pure LATAM Colombia SAS (Bogotá), Pure Latam Mexico, S. de R.L. de C.V. (Mexico City), and a São Paulo office. The Peru page is more careful: it refers to “our local partner” while still using “Acting as your Holder.” Treat Peru — and, unless a named subsidiary appears, Argentina and Costa Rica — as partner-network coverage, not proven own-entity holder. That distinction matters when the registration is the only legal hook you have in-country.

The commercial motion that makes Pure Global the closest analog is the fee. The Mexico page publishes “Starting at $2,000/year” and a fee calculator. The 5 February 2026 PR Newswire release, “Pure Global Introduces Industry-First Flat-Fee Pricing Model for Full-Service Global MedTech Market Access” (PR 302680246), describes a standard multi-year flat annual fee per registration and names Brazil, Mexico, and Colombia among the markets. The same release is explicit about what sits outside the fee: government fees, certified translations, and marketing materials. AI-assisted dossier workflows appear on the site. Pure Global is not a first-in-human CRO, and this comparison is not a CRO comparison.

Facts above are taken from Pure Global’s public market and company pages and the 5 February 2026 release, retrieved 23 August 2026. No clients, emails, or extra country names are added.

What “flat fee” has to mean on a LATAM holder file

A Latin American sanitary registration is not a consulting memo. The regulator issues the certificate to an in-country legal person. That person is the titular / detentor / registration holder. In several markets the same person, or a closely tied license, is also the importer of record. If the holder is your distributor, the registration is commercial leverage. If the holder is an independent specialist, you can change distributors without rewriting the entire file — provided the agreement actually allows a transfer.

The cash cost of that file is not only the holder’s time. Government submission fees are real invoices. Certified or sworn translations of IFUs, labels, and the technical file are often the largest hidden line, especially in Portuguese (Brazil) and Spanish with sworn-translator rules (Argentina, and frequently Brazil). A “flat annual fee” that excludes those two items is still a subscription. It is not the same product as a subscription that includes them.

bioaccess® publishes that product as the LATAM Launch Subscription on bioaccessla.com/market-access. The model is: register and hold an already FDA-cleared (510(k)/PMA) or CE-marked device; act as in-country registration holder and importer of record through own local entities; include certified Spanish/Portuguese translations (sworn where required) and government submission fees; hold across 19 LATAM markets (six core markets detailed on the hub — ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID — with MINSA, ARCSA, DNM/SRS, and DIGEMAPS also named on the same page). Specific subscription rates are under review — contact for a quote. Multi-country discounts and a Trial-to-Market Bridge (20% off for clinical-trial clients, as published on the hub) sit on top of that structure. The LATAM Importer of Record guide is the country-rule companion.

Two items sit outside the bioaccess® flat fee because they cannot be bundled honestly at a flat rate: Brazil BGMP manufacturing-site audit and telecom/EMC + RF homologation for wireless devices. Those are managed end-to-end and billed at vendor cost plus published G&A. That carve-out is on the market-access page. It is not the same carve-out as “government fees and certified translations extra.”

Pure Global vs bioaccess® — what is inside the fee

Dimension	Pure Global (public)	bioaccess®
Product	Global medtech market access; independent AR / license holder; AI dossier workflows	LATAM Launch Subscription: sanitary registration + holder / IOR for already-cleared devices
Public LATAM market pages	Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru	Hub details Brazil, Colombia, Mexico, Argentina, Chile, Peru; coverage described as 19 LATAM markets; also names MINSA, ARCSA, DNM, DIGEMAPS
Own local entity vs partner	Own subsidiaries published for BR / MX / CO. Peru page: local partner. AR / CR not proven as own entities on the public pages reviewed	Holds through own in-country entities; defined transfer provisions so the registration is not leverage
Holder roles named	BRH, MRH, INVIMA Legal Representative / CCAA importer language	Registration holder / IOR across the LATAM set; country rules on the IOR guide
Published fee	Flat annual fee starting USD $2,000/year (Mexico page + 5 Feb 2026 PR)	Flat all-inclusive annual subscription per country and device family; rates under review — contact for a quote
Government submission fees	Outside the published flat fee (PR)	Included
Certified translations	Outside the published flat fee (PR)	Included; in-house production; sworn where required (Brazil, Argentina)
Marketing materials	Outside the published flat fee (PR)	Not sold as a creative-agency line; labels/IFU translation for the dossier is in the subscription
Submission Guarantee	No public equivalent found (dossier submitted on a committed schedule or a fee credit)	Yes — submission workmanship; portion of that country’s annual fee credited if we miss what we control; full terms in the proposal
Trial-to-Market Bridge	Not a published FIH CRO + commercial registration stack	Same partner from LATAM clinical trial to commercial registro sanitario (20% off for clinical-trial clients, as published)
FIH CRO	Not this product	Separate live CRO practice; not what this page sells

Read the table as a product map. If you need a global AR network and a published $2,000 starting number, Pure Global is a real option — just budget government fees and certified translations as extra, because they said so. If you need a LATAM holder who already put those two lines inside the annual fee, holds through own entities, and will still be the same firm if you ran (or will run) the trial in the region, that is bioaccess®.

When Pure Global is the better fit

• You want one global market-access vendor beyond LATAM and you are already buying their U.S./Canada or other-market stack.
• You want a published starting price of $2,000/year and you are willing to pay government fees, certified translations, and marketing materials as separate invoices.
• Your live markets are Brazil, Mexico, and/or Colombia, where Pure Global publishes own legal entities, and you do not need Andean / Southern Cone / Central American / Caribbean breadth on day one.
• You want their AI dossier workflow as the primary production method.

None of those are insults. They are scope. A global RA firm is allowed to be good at global RA.

When the LATAM Launch Subscription is the better fit

• The near-term milestone is commercial registro sanitario in Latin America, not a worldwide RA retainer.
• You want government submission fees and certified translations inside the annual fee, not as change orders.
• You want the holder to be an own local entity with a written transfer path — including markets where Pure Global’s public page still says “local partner.”
• You need more than the six Pure Global LATAM market cards, or you need the importer-of-record rules (multi-importer vs single-IoR) documented country by country.
• You already used, or will use, bioaccess® as the LATAM clinical-trial CRO and want one accountable partner through commercialization (Trial-to-Market Bridge).
• You want a Submission Guarantee on the workmanship of the submission — not a promise that the agency will approve.

How to run the RFP without inventing numbers

1. Ask each vendor to list the LATAM countries where their own legal entity will be the titular, and the countries where a partner will. Demand the local company name.
2. Ask for a written inclusion list: government fees, sworn translations (page count and languages), holder/IOR year one and renewal, agency queries, and transfer of the registration if you leave.
3. Ask whether marketing-material production is in or out. Pure Global’s PR already answers “out.”
4. Ask what happens if the dossier is late because of the vendor. A KPI is not a fee credit.
5. Ask who holds the translation memory. bioaccess® publishes that the glossary is the manufacturer’s property.
6. Do not treat “starting at $2,000” as all-in LATAM cost. Add the two excluded lines before you compare it to a bioaccess® quote.

bioaccess® pricing remains under review — contact for a quote. Country pages and the compare set already published: Brazil / ANVISA, Mexico / COFEPRIS, Colombia / INVIMA, Argentina / ANMAT, Chile / ISP, vs Emergo by UL, vs Qserve Group.

FAQ — Pure Global LATAM device registration

Does Pure Global offer a flat annual fee?

Yes, on its public Mexico page (starting at $2,000/year) and in the 5 February 2026 PR Newswire release. The same release states that government fees, certified translations, and marketing materials sit outside that fee.

Does Pure Global act as BRH, MRH, or INVIMA Legal Rep?

Those roles are on its Brazil, Mexico, and Colombia market pages. Own-entity language is published for those three countries. Peru is described with a local partner.

Is Pure Global a first-in-human CRO?

No. Do not hire it — or bioaccess®’s market-access team — as a substitute for an ISO 14155 FIH operating system. Commercial registration and investigational-device trials are different regulatory acts.

What does bioaccess® include that the Pure Global flat fee excludes?

On the published record: government registration submission fees and certified translations, plus own-entity holder across the 19-market LATAM coverage, a Submission Guarantee, and the Trial-to-Market Bridge. bioaccess® rates are under review — contact for a quote.

Can a sponsor use both?

Yes. A common pattern is a global RA firm for FDA/EU work and bioaccess® for LATAM holder / IOR. Documentation is built to reuse the FDA or CE technical file.

Where should a sponsor start?

Market access, IOR rules, then contact or book a meeting.

Sources for competitor facts: pureglobal.com market and company pages and PR Newswire release 302680246 (5 February 2026), retrieved 23 August 2026. bioaccess® facts: bioaccessla.com/market-access and bioaccessla.com/latam-importer-of-record (July 2026 review). No invented clients, emails, statistics, or country lists.