cms.bioaccessla.com

Author: Julio Martinez-Clark

  • REGULATE México COFEPRIS Holder vs bioaccess® LATAM Market Access

    The URL regulate.com.mx/holder-mexico-cofepris is an exact-match page for “Mexico Registration Holder COFEPRIS.” REGULATE México is a homegrown shop that sells legal representation before COFEPRIS for foreign manufacturers that do not have a Mexican office. That is a legitimate one-country titular product. This page describes what REGULATE actually publishes, then contrasts it with multi-country registration holding from bioaccess®.

    What REGULATE México publishes

    The holder page (retrieved 23 August 2026) walks a three-step COFEPRIS path: (1) alta de establecimiento — aviso de funcionamiento and responsable sanitario for a Mexico-constituted company that will appear on the sanitary registration; (2) product notification / registro sanitario; (3) activity permits for import and publicity once the registro exists. For foreign firms it contrasts three models:

    • Filial in Mexico — the manufacturer’s own titular. Advantages: control of timelines. Disadvantages they list: investment, time to constitute, a declared physical domicile, a quality system, and a farmaco / tecnovigilancia unit.
    • Holder (“empresa estratégica”) — an establishment already notified to COFEPRIS, with a health professional as responsable sanitario and an existing farmaco / tecnovigilancia unit. They present this as avoiding the time to constitute a new Mexican company.
    • Agreement with distributors — one or several distributors on the record. They list the usual risks: commission disputes, contracts written for the distributor, and confidentiality / industrial-design leakage.

    FAQ facts they publish: they tell sponsors not to believe anyone who promises less than about 10 months after filing (they attribute current clocks to contingency backlog); sanitary registration validity is 5 years, then a prórroga; modifications include cesión de derechos, presentations, distributors, importers, and shelf life; as many distributors/importers as desired if each has its own aviso de funcionamiento. They say the work is done by RA specialists / pharmaceutical chemists who have worked inside COFEPRIS and/or Terceros Autorizados, and they claim review of around 500 expedientes with more than 95% success — those figures are theirs, not independently restated here as fact. They also work medicines, herbal remedies, cosmetics, supplements, non-alcoholic beverages, and foods. Devices are one of several product classes.

    What that product is — and is not

    REGULATE is a Mexico holder + dossier + import/publicity-permit shop. It is not a published multi-country subscription, not a holder that includes government fees and certified translations in one annual fee across LATAM, and not a trial-to-market CRO bridge. If Mexico is the only label, a homegrown “empresa estratégica” can be the right titular. If Mexico is one of five, the operating system matters more than the exact-match URL.

    COFEPRIS allows multiple importers and distributors on one registration. That is why the independent-holder model they describe is useful. Details and the equivalence route: Mexico COFEPRIS.

    REGULATE México vs bioaccess®

    Dimension REGULATE México bioaccess®
    Public product COFEPRIS representación legal / holder vs filial vs distributor Register + hold already-cleared devices
    Who is the titular Their “empresa estratégica” already notified to COFEPRIS bioaccess®, working with its local partner in Mexico, held for the manufacturer
    Product mix published Devices plus medicines, herbals, cosmetics, foods FDA-cleared / CE-marked medical devices
    Timeline they publish ~10 months post-filing; do not believe shorter promises Experience-based COFEPRIS class clocks and vía abreviada target; agency discretion reserved
    Multi-country Mexico page Multi-country coverage with published pricing in five markets
    Holder as leverage Warns against distributor-as-titular Same doctrine, plus defined transfer provisions and a published IOR map

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina, and Chile and other markets are quoted case by case; named pathways include ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM/SRS, and DIGEMAPS. The registration is held for the manufacturer’s benefit, with defined transfer provisions in the agreement; it is not leverage. 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). See the LATAM importer-of-record rules for how holder and importer split by country.

    When to use which

    Use REGULATE when the search is literally “holder Mexico COFEPRIS,” the catalog may include non-device health products, and there is no second regulator on the launch plan. Use bioaccess® when the same device family must be held in Mexico and in other LATAM markets under one holder, and when the same partner already ran — or will run — the first-in-human study.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • CAPIBAM Independent COFEPRIS Holder vs bioaccess® LATAM Market Access

    CAPIBAM’s entire public site is the independent Mexico Holder pitch. The homepage at capibammdr.com (retrieved 23 August 2026) says they act as Titular de Registro (Holder) for medical devices before COFEPRIS, independent of the distribution network. For a sponsor who only needs Mexico and only devices, that is a clean one-country product. This article states what they publish, then shows why bioaccess® is the multi-country registration holder rather than another Mexico boutique.

    What CAPIBAM publishes

    CAPIBAM presents itself as a device-only sanitary-regulation shop. Public claims on the homepage:

    • They lead “estrategia regulatoria y representación sanitaria” of medical devices in Mexico and act as Titular de Registro (Holder).
    • Independence from the distribution network is the point: titularidad stays under the manufacturer’s control.
    • Services: Class I–III registros, modifications, prórrogas, tecnovigilancia (including Informes Periódicos de Seguridad), and avisos / permisos de publicidad.
    • More than 13 years of trajectory (their figure).
    • Members of CAMEXA (Cámara Mexicano-Alemana de Comercio e Industria).
    • They work with national and international manufacturers, distributors, and comercializadoras. Contact phone published: +52 (55) 7441 9286.

    They do not publish a multi-country LATAM holder list, an all-in annual subscription with government fees and certified translations, or a clinical-to-commercial bridge. They are a Mexico device Holder. That is the product.

    Independent holder is the right Mexico model — country is the constraint

    The COFEPRIS rule is simple: the registration names a Mexican establishment. If that establishment is also the exclusive distributor, the manufacturer has outsourced both the license and the channel. CAPIBAM’s public wording is the correct commercial answer for Mexico-only: an independent titular, multiple channels, tecnovigilancia and publicity permits in the same shop. The constraint is geography. A U.S. or EU manufacturer that also needs ANVISA, INVIMA, ANMAT, ISP, or DIGEMID will otherwise hire a second titular, a third dossier vendor, and a fourth translator — and will rediscover that Argentina fuses holder and importer while Brazil lets the detentor authorize several importadores.

    Country detail: Mexico COFEPRIS. Multi-importer vs single-IoR map: LATAM IOR.

    CAPIBAM vs bioaccess®

    Dimension CAPIBAM bioaccess®
    Public product Independent COFEPRIS Holder, devices only Registration holder (own entity in Colombia; local partner elsewhere), already-cleared devices
    Classes published I–III registros, prórrogas, tecnovigilancia, publicity Class I–III COFEPRIS; other LATAM classes per country page
    Affiliation they publish CAMEXA member Miami HQ + regional offices including Mexico City; own entity in Colombia; local partner elsewhere
    Years they publish 13+ (company site) 15+ years hands-on COFEPRIS / INVIMA / ANVISA / ANMAT (company market-access page, July 2026)
    Bundle Mexico RA / holder (pricing not published as all-in LATAM) Certified translations + holder/IOR; Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Trial to market Not published Same firm can run the FIH trial and hold the commercial registration

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina, and Chile and other markets are quoted case by case; named pathways include ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM/SRS, and DIGEMAPS. The registration is held for the manufacturer’s benefit, with defined transfer provisions in the agreement; it is not leverage. 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). See the LATAM importer-of-record rules for how holder and importer split by country.

    CAPIBAM is a fair Mexico-only Holder. bioaccess® is the operator when the same device family must stay off the distributor’s license in more than one LATAM country.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • RAF Consulting COFEPRIS Titular vs bioaccess® LATAM Market Access

    Teams searching “RAF Consulting COFEPRIS” or “titular de registro México” are usually looking for an independent Mexico Registration Holder (MRH) — a Mexican legal entity that will sit on the COFEPRIS sanitary registration so a foreign manufacturer does not have to give the license to its first distributor. That is a real, one-country job. RAF Consulting publishes dedicated holder pages for it in Spanish and English. This article names that product fairly, then explains when multi-country registration holding from bioaccess® is the better fit.

    What RAF Consulting publishes

    RAF Consulting is a Mexico regulatory shop with a public titular de registro / Mexico Registration Holder offer. The Spanish page is rafconsulting.net/titular-registro.php; the English twin is rafconsulting.net/eng/registration-holder.php (both checked as indexed holder URLs on 23 August 2026). Public positioning: independent MRH, not a commercial distributor. The shop also publishes dossier work and a tecnovigilancia unit framed against NOM-240. The commercial contrast they themselves use is independent holder versus distributor-as-titular — the same contrast U.S. sponsors already hear from global RA brands.

    What those pages do not publish — and this is a finding, not an insult — is a multi-country LATAM holder subscription, government fees and sworn translations inside one annual fee, or a trial-to-commercialization bridge with the same operator. RAF is a Mexico titular. Treat it as one.

    Why Mexico needs a titular at all

    COFEPRIS issues the sanitary registration in the name of a Mexico-established establishment. The titular del registro carries legal responsibility for the product. A foreign manufacturer that is not constituted in Mexico must appoint someone who is. That someone can be (1) the manufacturer’s own Mexican filial, (2) an independent holder / “empresa estratégica” already notified to COFEPRIS, or (3) a commercial distributor that will also be the titular. Option 3 is still common. It is also how a registration becomes leverage: changing the commercial channel later usually means a cesión de derechos, a new dossier, or both.

    COFEPRIS can name multiple distributors and importers on a single registration. That is why an independent titular is useful: the manufacturer keeps the license and adds or drops commercial partners without handing them the asset. See Mexico — COFEPRIS medical device registration and the importer-of-record guide.

    Mexico also has an equivalence route (vía abreviada) for devices already approved and marketed by the same manufacturer in a reference country (U.S. FDA, Health Canada, or Japan). A CE mark alone does not qualify. bioaccess® manages Class I–III COFEPRIS work on that pathway and on the standard route. Typical published processing targets (~30 / ~35 / ~60 working days by class; ~30 working days on the equivalence target) are routinely exceeded in practice; COFEPRIS retains full technical discretion. Approval is never guaranteed.

    RAF Consulting vs bioaccess®

    Dimension RAF Consulting bioaccess®
    Public product Independent Mexico MRH / titular de registro + dossier + tecnovigilancia Register + hold already-cleared devices
    Geography published Mexico / COFEPRIS Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case; own entity in Colombia; local partner elsewhere; country pages for Mexico, Brazil, Colombia, Argentina, Chile
    Who holds the license RAF as independent titular (their pages) bioaccess® under contract, working with its local partner in Mexico, for the manufacturer’s benefit
    Distribution Positions as not the distributor Holder is not the commercial distributor; registration is not leverage
    Gov fees + certified translations Not published as one included annual bundle Certified translations in-house (sworn where required); See the rate card for what the one-time registration fee covers
    Trial-to-market Not a published FIH CRO + holder bridge Same firm can run the FIH trial and hold the commercial registration

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina, and Chile and other markets are quoted case by case; named pathways include ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM/SRS, and DIGEMAPS. The registration is held for the manufacturer’s benefit, with defined transfer provisions in the agreement; it is not leverage. 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). See the LATAM importer-of-record rules for how holder and importer split by country.

    When RAF is the right hire

    Hire a Mexico-only independent MRH when the commercial plan is Mexico, the manufacturer wants a homegrown COFEPRIS face, and there is no second-country clock. RAF’s public pages are built for that search. Hire bioaccess® when Mexico is the first of several labels — Brazil ANVISA, Colombia INVIMA, Argentina ANMAT, Chile ISP, Peru DIGEMID, and other LATAM markets quoted case by case — and the manufacturer wants one operator, one pricing structure, and a holder who will not become the commercial channel.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • Registro sanitario de dispositivos médicos en LATAM: titular vs. distribuidor

    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: el servicio de market access de bioaccess®. 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 bajo contrato (en Colombia, a través de su propia entidad colombiana; en los demás países, con su socio local), 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 conviene confirmar en cualquier cotización:

    • 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.

    Los precios de bioaccess® son precios en dos partes: una tarifa única de registro por país según la clase del dispositivo y, desde el año 2, una tarifa anual de titular más baja (publicada para México, Colombia, Brasil, Perú y Argentina en la tabla de precios). Se facturan aparte 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 publica precios en dos partes para México, Colombia, Brasil, Perú y Argentina; Chile y otros mercados se cotizan caso por caso. No se añaden países aquí que no estén en esas páginas.

    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 bajo contrato (en Colombia, a través de su propia entidad colombiana; en los demás países, con su socio local).

    Registro, 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. Nadie puede prometer 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 lo que ofrece 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 bajo contrato (en Colombia, a través de su propia entidad colombiana; en los demás países, con su socio local), con disposiciones de transferencia en el acuerdo. Precios publicados para México, Colombia, Brasil, Perú y Argentina; otros mercados se cotizan caso por caso; detalle en el hub de market access.

    ¿Cuánto cuesta?

    Los precios de bioaccess® son precios en dos partes: una tarifa única de registro por país según la clase del dispositivo y, desde el año 2, una tarifa anual de titular más baja (publicada para México, Colombia, Brasil, Perú y Argentina en la tabla de precios).

    ¿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.

  • MedEnvoy vs bioaccess®: Mexico Registration Holder and the Rest of LATAM

    “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 registration holder (own entity in Colombia; local partner elsewhere). 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, a multi-country registration holder with published LATAM pricing. 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:

    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 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 trial-to-commercial LATAM CRO bridge appears 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 multi-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 two-part market-access pricing for Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets are quoted case by case. bioaccess®’s own Colombian entity holds the file in Colombia; elsewhere bioaccess® holds it with its local partner. Transfer provisions are defined 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 Register + hold already-cleared devices
    Public LATAM holder pages Four: Mexico, Colombia, Peru, Brazil Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets quoted case by case
    Independence / anti-leverage Core pitch — do not let the distributor hold the registration Same doctrine, plus written transfer provisions (own entity in Colombia; local partner elsewhere)
    Bundle (gov fees + certified translations) Not published as an all-in annual inclusion Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    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 Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Quality claim ISO 13485 claimed Operating model published on the market-access hub (track record is self-reported as of July 2026)
    Trial to market 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 registration holder, 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 across LATAM.”

    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 bioaccess® as holder under contract (own entity in Colombia; local partner elsewhere), with transfer language, including the IOR variants (multi-importer vs single-IoR) documented on the IOR guide.
    • You want the same firm that can run the LATAM trial to 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?

    bioaccess® answers those in writing. 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).

    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 a contracted holder 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 multi-country LATAM registration holder with published two-part pricing.

    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.

  • Freyr vs bioaccess®: LATAM Device Registration and the Brazil Registration Holder

    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 registration holder (own entity in Colombia; local partner elsewhere). 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 one contracted in-country titular (own entity in Colombia; local partner elsewhere) that 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. No LATAM FIH CRO + commercial registration bridge 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, ask who signs your contract and who answers to ANVISA. What protects you is one accountable contract and a transfer covenant that is actually in the agreement.

    bioaccess® holds LATAM registrations for the manufacturer’s benefit under contract (in Colombia through its own Colombian entity; elsewhere with its local partner), with defined transfer provisions so the file is not leverage. Brazil is one of the five markets with published pricing (Mexico, Colombia, Brazil, Peru and Argentina); in Brazil bioaccess® acts as BRH working with its local partner (see the ANVISA country page). bioaccess® provides certified Portuguese (sworn where required). Brazil pricing: a one-time registration fee, then an annual holder fee from year 2 of $6,000 (Class I/II) or $7,500 (Class III/IV) (rate card). Brazil BGMP site audit is billed separately.

    Freyr vs bioaccess®

    Dimension Freyr Solutions (public) bioaccess®
    Product Global RA / market access; LATAM device-registration hub; annual BRH support Sanitary registration + holder / IOR
    Public LATAM footprint “Strong presence” BR / MX / CO; hub lists ANVISA, COFEPRIS, ANMAT, INVIMA Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets quoted case by case
    Brazil Registration Holder Freyr acts as BRH and cites a partner network across Brazil — ask which model applies to your CNPJ BRH under contract, with our local partner in Brazil; 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 Certified translations in-house; Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Translation Listed as a challenge (“approved translation”), not as included in-house production In-house; sworn where required; manufacturer owns the translation memory
    Pricing Project / line-item plus annual BRH support; no public all-in LATAM subscription Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Trial to market 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.
    • Your live LATAM set is the BR / MX / CO presence (plus ANMAT as listed) and you do not need a wider LATAM holder map on day one.

    When bioaccess® market access is the better fit

    • The buying criterion is “who is on the certificate,” not “who can coordinate a holder.”
    • You need holder / IOR beyond the four regulators Freyr lists, or you need the multi-importer vs single-IoR map.
    • You want one partner from LATAM trial to commercial registration.

    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 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). 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” an approval guarantee?

    No. It is a marketing KPI. 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 registration holder.

    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.

  • Pure Global vs bioaccess®: Flat-Fee LATAM Device Registration and What Is Inside the Fee

    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: sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner) and certified translations, 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 is a practitioner comparison, not a smear. Pure Global is a reasonable global RA / holder option in the markets it actually names. bioaccess® is a LATAM-only registration holder with published two-part pricing.

    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. Check what each quote includes before you compare.

    bioaccess® publishes that product 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 under contract (in Colombia through its own Colombian entity; elsewhere with its local partner); provide certified Spanish/Portuguese translations (sworn where required); hold across Latin America (published pricing in Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets quoted case by case). 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. 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 Sanitary registration + holder / IOR for already-cleared devices
    Public LATAM market pages Argentina, Brazil, Colombia, Costa Rica, Mexico, Peru Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets quoted case by case
    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 Own Colombian entity in Colombia; local partner elsewhere; 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) Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Government submission fees Outside the published flat fee (PR) See the rate card for what the one-time registration fee covers
    Certified translations Outside the published flat fee (PR) In-house production; sworn where required (Brazil, Argentina); See the rate card for what the one-time registration fee covers
    Marketing materials Outside the published flat fee (PR) Not sold as a creative-agency line; labels/IFU translation for the dossier is part of the registration work
    Trial to market Not a published FIH CRO + commercial registration stack Same partner from LATAM clinical trial to commercial registro sanitario
    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 that publishes two-part pricing, 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 bioaccess® market access is the better fit

    • The near-term milestone is commercial registro sanitario in Latin America, not a worldwide RA retainer.
    • You want one contracted holder with a written transfer path and published two-part pricing (its own entity in Colombia; its local partner elsewhere).
    • 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.

    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.
    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 quotes.

    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). 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: registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified translations. 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).

    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.

  • Panama Eye Centre / Orillac-Calvo MINIject: STAR-I Site and the CRO That Owns MINSA

    Figures cited from ClinicalTrials.gov NCT03193736, the British Journal of Ophthalmology STAR-I paper, published bioaccess® Panama pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current MINSA, CNBI, and FDA rules with qualified advisers. We name only the clinic and trial those sources support. We do not claim iSTAR Medical or MINIject as a bioaccess® client.

    If you searched Panama Eye Centre clinical trial, Orillac-Calvo MINIject, STAR-I Panama, or go direct to the eye clinic in Panama, you are following a clinic name that is genuinely in the public file. Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a real ophthalmic research site in Panama City. It is not the operator of the MINSA / CNBI file.

    bioaccess®’s position is simple and it is not adversarial: Panama Eye Centre is the site. The First-in-Human CRO still owns MINSA/CNBI, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Panama is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A STAR-I listing does not become a CRO.

    This page is for the ophthalmic-clinic query. It does not repeat clinical trials in Panama, the March 2026 Panama essay, or The Panama Clinic first-in-human. Those pages stay the country system and the large-hospital page (Axoft, Newrotex). This page answers the Orillac-Calvo / Panama Eye Centre search.

    Why the clinic name wins the search — and why that is not a CRO

    Device registries and journals write the implant, the city, and the site. They rarely write the CRO. MINIject STAR-I is the clean public example for this Panama City eye clinic.

    NCT03193736 (STAR-I), retrieved 23 August 2026: official title is a prospective, open, multicenter clinical trial with one cohort analysing the efficacy and safety of MINIject in patients with open-angle glaucoma uncontrolled by topical hypotensive medications. Lead sponsor: iSTAR Medical. Status: completed. Start 19 June 2017; primary completion 16 April 2018; completion 25 November 2019. Locations listed: Maxivision Eye Hospital, Hyderabad, India, and Clinica de ojos Orillac-Calvo, Panama City, Panama.

    The British Journal of Ophthalmology two-year STAR-I paper (trial registration NCT03193736) identifies the Panama site as Panama Eye Centre (previously Clínica de Ojos Orillac-Calvo), Panama City, Panama, and states IRB approval was obtained from that hospital (and from Maxivision). The paper reports a prospective, multicentre, first-in-human, single-arm study of stand-alone MINIject implantation in 25 patients; implants between June and October 2017 by three surgeons in Panama and India; two-year follow-up for 21 patients. We cite the published outcomes as journal facts, not as a bioaccess® result: mean IOP 23.2 to 13.8 mmHg at two years (-40.7 percent) on fewer medications, as the paper states. We will not add a PI name the registry listing we retrieved did not put in the site row.

    That file is useful public information about a site-named Panama ophthalmic FIH. It is not a bioaccess® case study. As of this writing, bioaccess® does not list iSTAR Medical as a client on our published pages, and this article will not invent that relationship.

    Panama Eye Centre is a site. The CRO is the operator.

    A Panama City eye clinic can provide the OR, imaging, and surgeons who have already taken a supraciliary micro-invasive glaucoma device through a published first-in-human cohort. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

    What a site can typically do when a sponsor goes direct:

    • Discuss investigator interest and surgical feasibility — when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and clinic research rules.
    • Quote procedure and local staffing costs for the cases they will physically run.

    What the site is not built to own for an investigational device:

    • MINSA and CNBI. Panama’s Ministry of Health, through the Dirección Nacional de Farmacia y Drogas, is the national health authority. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). A hallway conversation with a surgeon is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work already described on the Panama pages, not a PI email.
    • Clinical trial insurance. Required. Our Panama essay publishes a typical premium range of $5,000-$15,000 depending on device risk and enrollment; that is a published planning band, not a quote for your protocol.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If Panama enrollment or the indication later needs Colombia, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.

    Going direct to Panama Eye Centre is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How MINSA and CNBI sit next to the clinic

    Use the country pages for the full pathway. Two published bioaccess® clocks, both live, both kept here as published rather than averaged into a third number:

    • On Clinical Trials in Panama: ethics typically 3-5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6-8 weeks. Per-patient costs on that page: $12,000-$22,000. A 10-patient FIH is described as typically $200K-$300K. Currency is the U.S. dollar.
    • On the March 2026 blog: early-feasibility is ethics-committee-driven; CNBI review timed to each committee’s meeting schedule; conservative submission-to-first-patient envelope 3-5 months including site prep and screening.

    Ask for a protocol-specific calendar. Do not treat a clinic hallway estimate as MINSA clearance. All bioaccess® Panama protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

    What the STAR-I public file actually supports — and what it does not

    • Device: MINIject (iSTAR Medical), STAR-I, NCT03193736.
    • Panama site: Clinica de ojos Orillac-Calvo on ClinicalTrials.gov; Panama Eye Centre, formerly Clinica de Ojos Orillac-Calvo, in the BJO paper.
    • Design: prospective, multicentre, first-in-human, single-arm; 25 implanted; Panama and India; completed 2019 on the registry.
    • Not claimed here: that iSTAR retained bioaccess®; that this clinic is The Panama Clinic; that Axoft or Newrotex ran here; that we have a named PI on this page beyond the three-surgeon statement in the journal (PD, CH, IKA) — we will not guess local identities those initials do not prove.

    What the CRO still does after you have a clinic name

    1. Regulatory-fit, not tourism. Panama is fast and bilingual. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the MINSA/CNBI packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

    bioaccess® has been active in Panama since the early 2010s. The firm was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates FIH device studies as a multi-country platform. That is the operator layer around a named Panama City eye clinic.

    Not a critique of the clinic

    Clínica de Ojos Orillac-Calvo / Panama Eye Centre is a serious ophthalmic resource. This page is not a critique of the site. A published STAR-I cohort is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator. If the hospital you actually typed was The Panama Clinic, use that page instead of stretching this one.

    Colombia is still on the map

    A Panama clinic search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream Panama Eye Centre / the site bioaccess® / the CRO
    Procedure OR, imaging, glaucoma service Protocol fit, training, device accountability
    Ethics Institutional committee calendar Packet, ICF, IB, CNBI-registered process
    National authority Not the permit holder by appearing on STAR-I MINSA / CNBI
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One building in Panama City Colombia (INVIMA) still on the platform

    Frequently asked questions

    Can I contract Panama Eye Centre or Orillac-Calvo directly?

    You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT03193736, become your MINSA/CNBI applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the clinic as the site if it is the right site for your protocol.

    Is this the same as The Panama Clinic?

    No. The Panama Clinic page covers Axoft and Newrotex, which publicly named bioaccess®, and Nanochon in independent press. This page is the sourced ophthalmic clinic for MINIject STAR-I. The buildings are separate.

    What does the CRO still do if the clinic is already identified?

    Regulatory-fit and country choice; the MINSA and CNBI packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia if Panama is not enough. The clinic still does the procedure.

    Did bioaccess® run STAR-I?

    We do not claim that. iSTAR Medical is the sponsor on the registry. This page exists because sponsors search the site name. It is not a STAR-I case study.

    Next step

    If the search that brought you here was Orillac-Calvo, Panama Eye Centre, or MINIject Panama, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Hospital: The Panama Clinic. Country: Panama, Colombia. Other clinics: CODET, Laser Center, Adrian Ebner.

  • Laser Center Santo Domingo FIH: GORE GDI Site and the CRO That Owns DIGEMAPS

    Figures cited from ClinicalTrials.gov NCT05557058, ICH GCP registry mirrors, published bioaccess® Dominican Republic pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DIGEMAPS, CONABIOS, and FDA rules with qualified advisers. We name only the clinic, investigator, and trial those sources support. We do not claim W. L. Gore and Associates as a bioaccess® client.

    If you searched Laser Center Santo Domingo clinical trial, Juan Batlle GORE glaucoma, Dominican Republic first-in-human ophthalmic, or go direct to the site in Santo Domingo, you are following a clinic name that is genuinely in the public file. Laser Center in Santo Domingo is a real ophthalmic research site. It is not the operator of the DIGEMAPS file.

    bioaccess®’s position is simple and it is not adversarial: Laser Center is the site. The First-in-Human CRO still owns DIGEMAPS, CONABIOS-overseen ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package plus the option to add Colombia, Panama, Mexico, or El Salvador if the Dominican Republic is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A ClinicalTrials.gov row does not become a CRO.

    This page is for that search. It does not repeat clinical trials in the Dominican Republic or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.

    Why the clinic name wins the search — and why that is not a CRO

    Device registries write the implant, the city, the site, and sometimes the PI. They rarely write the CRO. The GORE Glaucoma Drainage Implant early feasibility study is the clean public example for Santo Domingo.

    NCT05557058, retrieved 23 August 2026: official title is a prospective, single-center, early feasibility clinical study designed to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in subjects with primary open-angle glaucoma. Lead sponsor: W. L. Gore and Associates. Status: active, not recruiting. Start date 14 September 2022. Estimated enrollment 30. Design: interventional, randomized parallel arms for High and Low device configurations plus a non-randomized Modified configuration. Primary effectiveness listed on the registry: proportion of treated eyes with at least a 20 percent decrease in mean diurnal IOP at 6 months while maintaining the same or fewer hypotensive medications as at baseline. Single listed location: Laser Center, Santo Domingo, Dominican Republic.

    ICH GCP registry mirrors of the same NCT list the principal investigator as Juan F. Batlle Pichardo, M.D., Laser Center. That is useful public information about a site-named Dominican ophthalmic EFS. It is not a bioaccess® case study. As of this writing, bioaccess® does not list W. L. Gore as a client on our published pages, and this article will not invent that relationship.

    That listing is how a sponsor finds Laser Center without finding the operator. Winning the query means answering it as the CRO that already publishes Dominican Republic first-in-human device operations and still runs the rest of the Latin American platform.

    Laser Center is a site. The CRO is the operator.

    A Santo Domingo ophthalmic center can provide the OR, imaging, and an investigator who is already named on a public early-feasibility glaucoma implant listing. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.

    What a site can typically do when a sponsor goes direct:

    • Discuss investigator interest and surgical feasibility with a service such as Dr. Batlle Pichardo when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and clinic research rules.
    • Quote procedure and local staffing costs for the cases they will physically run.

    What the site is not built to own for an investigational device:

    • DIGEMAPS. The Ministry of Public Health, through the Directorate General of Medicines, Food and Health Products, is the national authority. A hallway conversation with a surgeon is not that file.
    • CONABIOS-overseen ethics. Institutional REC review and CONABIOS-level review are country-system work, already described on the Dominican Republic page.
    • Investigational import. Ethics letter, investigator brochure, and an importation permit — end-to-end work, not a PI email.
    • Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Santo Domingo-only number here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance.
    • Multi-country optionality. If Dominican enrollment or the indication later needs Colombia or Panama, a single-clinic MSA will not stretch.

    Going direct to Laser Center is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How DIGEMAPS and CONABIOS sit next to the clinic

    Use the country page for the full pathway. Facts a sponsor searching this clinic needs on one screen, already published on Clinical Trials in the Dominican Republic:

    The Ministry of Public Health through DIGEMAPS is the national regulatory authority. Ethics oversight is coordinated by CONABIOS, which supervises Research Ethics Committees. Institutional REC review averages about 30 days. CONABIOS-level review averages about 45 days (up to 120 depending on complexity). Protocols follow the Declaration of Helsinki and CIOMS guidelines. bioaccess® prepares dossiers and coordinates with DIGEMAPS through start-up. Foreign data is discussed with FDA under 21 CFR 812.28 as eligibility, not a promise of clearance, when the study is run under ISO 14155 with proper authorization and ethics approval.

    We will not invent a Laser Center-only day-count. Ask for a protocol-specific calendar. A surgeon email is not a DIGEMAPS approval.

    What the GORE public file actually supports — and what it does not

    • Device: GORE Glaucoma Drainage Implant, several configurations (registry).
    • Site: Laser Center, Santo Domingo, Dominican Republic (NCT05557058 locations).
    • PI on registry mirrors: Juan F. Batlle Pichardo, M.D., Laser Center.
    • Design: prospective, single-center, early feasibility; estimated n=30; start 14 September 2022; active, not recruiting on the 23 August 2026 snapshot.
    • Not claimed here: that the NCT named bioaccess®; that Laser Center is the only ophthalmic site in the Dominican Republic; that we have GORE outcomes; that Centro Laser marketing copy is the same as a first-in-human quality system.

    What the CRO still does after you have a clinic name

    1. Regulatory-fit, not tourism. The Dominican Republic is a sourced ophthalmic EFS geography. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the DIGEMAPS / CONABIOS packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

    bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Santo Domingo site.

    Not a critique of the clinic

    Laser Center and Dr. Batlle Pichardo are serious ophthalmic resources. This page is not a critique of the site. A public EFS listing is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.

    Colombia is still on the map

    A Santo Domingo search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream Laser Center / the site bioaccess® / the CRO
    Procedure OR, imaging, glaucoma service, PI Protocol fit, training, device accountability
    Ethics Institutional REC calendar Packet, ICF, IB, CONABIOS coordination
    National authority Not the permit holder by being listed on an NCT DIGEMAPS
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One building in Santo Domingo Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

    Frequently asked questions

    Can I contract Laser Center Santo Domingo directly?

    You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named on NCT05557058, become your DIGEMAPS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate Laser Center as the site if it is the right site for your protocol.

    Who is the PI on the GORE GDI listing?

    Juan F. Batlle Pichardo, M.D., Laser Center, as stated on ICH GCP mirrors of NCT05557058. That fact does not make the PI your CRO.

    What does the CRO still do if the clinic is already identified?

    Regulatory-fit and country choice; the DIGEMAPS and CONABIOS packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or Panama if Santo Domingo is not enough. The clinic still does the procedure.

    Is an early feasibility study the same as a commercial first implant in LATAM?

    No. NCT05557058 is an investigational early feasibility program. A commercial first implant is launch activity. Do not mix the two when you brief a board.

    Next step

    If the search that brought you here was Laser Center or Juan Batlle, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: CODET Vision Tijuana, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country: Dominican Republic, Colombia, Panama.

  • Adrian Ebner Paraguay FIH: The PI Search and the CRO That Owns DINAVISA

    Figures cited from named public press, the live Hospital Italiano Asuncion page, the bioaccess® Supira program page, and DINAVISA-related country copy, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current DINAVISA and FDA rules with qualified advisers. We name only the PI, hospital aliases, and trials those sources support. We do not claim Protaryx, Artio, NuVera, Thoratec, or Vascudyne as bioaccess® clients. Supira is cited from a live bioaccess® page; we do not invent a CRO sentence the 2022 sponsor release does not contain.

    If you searched Adrian Ebner first-in-human, Adrián Ebner Paraguay clinical trial, Sanatorio Italiano Asuncion FIH, or go direct to the PI in Paraguay, you are following an investigator name that is genuinely in the public file. Dr. Adrián Ebner, Head of Cardiovascular at Sanatorio Italiano / Hospital Italiano / Italian Hospital, Asunción, is a real first-in-human cardiovascular investigator. He is not the operator of the DINAVISA file.

    bioaccess®’s position is simple and it is not adversarial: Dr. Ebner and the Italian Hospital are the site. The First-in-Human CRO still owns DINAVISA, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or Panama if Asunción is not the only fit. Sponsors who skip the CRO and email the PI still have to rebuild that stack. A press release that names the surgeon does not make the surgeon a CRO.

    This page is the PI-query page. The hospital-query page is already published at Hospital Italiano Asunción FIH. The program narrative stays at Supira Medical first-in-human trial, Paraguay. Do not treat this page as a second hospital essay. It answers the investigator-named search.

    Why the PI name wins the search — and why that is not a CRO

    Device press writes the implant, the city, and the surgeon. It rarely writes the CRO. Dr. Ebner is a repeated public example of that pattern. The hospital names in those releases vary — Sanatorio Italiano, Hospital Italiano, Italian Hospital Asunción — and we will use the alias each source used rather than collapsing them into a name we invented.

    Named first-in-human press we will stand behind (verified 23 August 2026), with the CRO rule stated once so it is not missed:

    • Protaryx transseptal puncture — December 2024. Cardiac Rhythm News reports completion of a first-in-human study on 3 December 2024 at Sanatorio Italiano de Asunción; five patients; ethics approval from the Research Ethics Committee of the Paraguayan Institute of Social Studies; procedures by Adrian Ebner, head of the cardiovascular department at the Sanatorio Italiano Hospital, with guidance by Gagan Singh (UC Davis). The release discusses 510(k) intent. Not a bioaccess® client claim.
    • Artio Amplifi vein dilation system — 2021. Interventional News reports Artio completed enrolment of a first-in-human study; five patients treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción. Not a bioaccess® client claim.
    • NuVera NuVision ICE catheter — July 2020. PR Newswire (6 July 2020) and Cardiac Rhythm News: first-in-human use; first participant treated for an atrial septal defect by PI Adrian Ebner, M.D., Head of the Cardiovascular Department at the Italian Hospital Asunción, with remote live-feed support from the NuVera team in the U.S. Not a bioaccess® client claim.
    • Thoratec HeartMate PHP — 2013. DAIC (28 March 2013): first human use of HeartMate PHP during high-risk PCI; procedures by Adrian Ebner, M.D., at Sanatorio Italiano in Asunción; chief of the Cardiovascular Department. Not a bioaccess® client claim.
    • Vascudyne TRUE Vascular Graft. Company / OTS release: first-in-human use for hemodialysis access; first procedures by Adrian Ebner, MD, Director of Endovascular and Cardiovascular Surgery at Sanatorio Italiano in Asunción, as part of an early feasibility study; five patients in that announcement. Later literature lists Ebner among authors of a first-in-human evaluation of the TRUE AVC conduit. Not a bioaccess® client claim.
    • Supira pVAD — September 2022. Sponsor release (16 September 2022) names PI Adrian Ebner at the Italian Hospital Asunción. The live bioaccess® program page places the same FIH at that hospital and reports later South American experience, Breakthrough designation, U.S. EFS (November 2024), and SUPPORT II (April 2026) as published there. We cite the bioaccess® page. We do not invent a CRO sentence the 2022 sponsor copy does not contain.

    That list is how a sponsor finds Dr. Ebner without finding the operator. It is also how a founder concludes that emailing the PI is the whole first-in-human plan. It is not. DINAVISA still exists after you have the name.

    The PI is a site. The CRO is the operator.

    An Asunción cardiovascular department can provide the cath lab, imaging, and an investigator who has taken several public first-in-human devices through first cases, sometimes with visiting or remote U.S. advisors. That is necessary. It is not sufficient for a first-in-human device study a U.S. board expects to survive FDA review.

    What a PI / hospital can typically do when a sponsor goes direct:

    • Discuss investigator interest and procedural feasibility — when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote procedure, bed, and local staffing costs for the cases they will physically run.

    What the PI is not built to own for an investigational device:

    • DINAVISA. Paraguay’s national sanitary authority (Dirección Nacional de Vigilancia Sanitaria) is the file a sponsor actually needs. A hallway conversation with a surgeon is not that file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
    • Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent an Asunción-only number here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The hospital runs the case. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Eligibility is not clearance. Supira’s later U.S. EFS and SUPPORT II path, as published on the bioaccess® page, is exactly why the early Latin American dataset has to be built as a file, not as a souvenir implant.
    • Multi-country optionality. If Paraguay enrollment or the indication later needs Colombia or Panama, a single-PI MSA will not stretch.

    Going direct to Dr. Ebner is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

    How DINAVISA sits next to the PI (the short version)

    The hospital page already states this. We repeat it here because the PI query is a different Google, not a different file.

    DINAVISA is the national sanitary authority. Ethics sits with the institutional committee — Protaryx press, for example, names the Research Ethics Committee of the Paraguayan Institute of Social Studies for that study. Import sits on a permit. Monitoring sits on ISO 14155. Those layers are why a CRO exists after you already know Dr. Ebner’s name.

    We will not invent a median DINAVISA day-count. The clocks we will repeat are already published elsewhere on bioaccessla.com and are country-specific, not PI-specific: Panama ethics 3-5 weeks and 6-8 weeks to first patient with bioaccess® coordination on Clinical Trials in Panama; Colombia ethics timed to each committee’s meeting schedule, and per-patient $15,000-$25,000 on that same comparison. Ask for a Paraguay protocol-specific calendar.

    All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

    The Tangent tricuspid feasibility file (NCT07140562)

    A sponsor searching Dr. Ebner’s name now also lands on a ClinicalTrials.gov record. Here the registry names him as the site contact, not as principal investigator (PI). A named contact is still a site. The operator layer is separate.

    • Record: NCT07140562 — prospective, multi-center, single-arm study of the safety and technical feasibility of the Tangent Tricuspid Annular Therapy System for transcatheter valve repair in severe, symptomatic functional tricuspid regurgitation (TR).
    • Sponsor: Tangent Cardiovascular Inc. (industry). No collaborator. No CRO named.
    • Site: Sanatorio Italiano, Asunción, Paraguay — the only location row, listed as recruiting.
    • Named person: Dr. Adrian Ebner, listed as the site contact. The record lists no overall official.
    • Status and size: recruiting; estimated enrollment 25.
    • Dates: actual start 15 July 2025; estimated primary completion August 2027; estimated completion September 2028; first posted 24 August 2025; last update posted 13 October 2026.
    • Not claimed here: that bioaccess® ran or runs this study; that the record calls it first-in-human (its title says safety and feasibility); that the site is the CRO.

    Registry checked 13 Oct 2026 (ClinicalTrials.gov record, live pull). Registry facts only. Not a claim that bioaccess® ran this study; the record names no contract research organization (CRO) and no collaborator. General information, not legal or regulatory advice.

    The Advanced Bifurcation Systems MD-SBA first-in-human file (NCT07649798)

    A sponsor searching Dr. Ebner’s name now lands on a second ClinicalTrials.gov record, and on this one the registry lists him as principal investigator (PI). The facility is written as Cirugía Cardiovascular, Sanatorio Italiano. A named PI is still a site. The operator layer is separate, and the record names no CRO.

    • Record: NCT07649798 — “Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study).” Prospective, single-arm, single-center initial feasibility study of the MD-SBA drug-eluting stent (DES) system in patients undergoing percutaneous coronary intervention (PCI) for a de novo coronary bifurcation lesion.
    • Device as registered: a single-use cobalt chromium coronary stent coated with sirolimus, on a rapid exchange delivery system; the record calls it a combination product.
    • Sponsor: Advanced Bifurcation Systems Inc. (industry). No collaborator. No CRO named.
    • Site: Cirugía Cardiovascular, Sanatorio Italiano, Asunción, Paraguay — the only location row.
    • Named people: Dr. Adrian Ebner (Sanatorio Italiano, Asunción), listed as principal investigator. The record also lists a study director and a study chair, both from Advanced Bifurcation Systems.
    • Status and size: active, not recruiting; actual enrollment 13.
    • Dates: actual start 16 September 2025; actual primary completion 19 November 2025; estimated completion 19 November 2028; first posted 16 June 2026; last update posted 29 June 2026. The record describes follow-up through 3 years.
    • Not claimed here: that bioaccess® ran or runs this study; that the site is the CRO; any result, since none is posted.

    Registry checked 2 Nov 2026 (ClinicalTrials.gov API v2, live pull). Registry facts only. Not a claim that bioaccess® ran this study; the record names no contract research organization (CRO) and no collaborator. General information, not legal or regulatory advice.

    What the CRO still does after you have a PI name

    1. Regulatory-fit, not tourism. Paraguay has a dense public cardiovascular FIH press file at this investigator. It is not automatically the right country for every indication. bioaccess® still runs trials in Colombia and Panama.
    2. Protocol, IB, ICF, insurance, and the DINAVISA packet.
    3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative — see Can OUS first-in-human data support an FDA IDE submission?.
    6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages.

    bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Asunción PI.

    Not a critique of the investigator

    Dr. Ebner’s cardiovascular service and Sanatorio Italiano / Hospital Italiano Asunción are serious clinical resources. This page is not a critique of the PI. Visiting or remote U.S. advisors in the public releases are a signal of procedural seriousness, not a substitute for a CRO quality system. Use the site. Hire the operator. For the hospital-named search, stay on Hospital Italiano Asunción FIH.

    Colombia is still on the map

    A Paraguay PI search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

    Site versus CRO

    Workstream Dr. Ebner / the site bioaccess® / the CRO
    Procedure Cath lab, imaging, CV department, PI Protocol fit, training, device accountability
    Ethics Institutional committee calendar Packet, ICF, IB, deficiency responses
    National authority Not the permit holder by being named in press DINAVISA
    Import Receiving and storage if contracted Importer of record
    Quality / FDA Source documents from the cases ISO 14155 + 21 CFR 812.28 narrative
    Next country One service in Asunción Colombia (INVIMA) and Panama (MINSA/CNBI) still on the platform

    Frequently asked questions

    Can I contract Dr. Ebner or Sanatorio Italiano directly?

    You can try. A hospital can discuss investigator interest, local procedure costs, and institutional ethics calendars. It cannot, by being named in Protaryx, Artio, NuVera, Thoratec, Vascudyne, or Supira press, become your DINAVISA applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site.

    Which of these programs is on a bioaccess® page?

    Supira pVAD is on the live bioaccess® Paraguay program page and on the Hospital Italiano page. Protaryx, Artio Amplifi, NuVera NuVision ICE, Thoratec HeartMate PHP, and Vascudyne TRUE graft are named public press. We will not invent a CRO role on those five.

    What does the CRO still do if the PI is already identified?

    Regulatory-fit and country choice; the DINAVISA and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or Panama if Asunción is not enough. The hospital still does the procedure.

    Is this the same page as Hospital Italiano Asunción FIH?

    No. That page is the hospital-named page, centered on the Supira public file. This page is the PI-named page and lists the broader press file without converting those sponsors into clients.

    Next step

    If the search that brought you here was Adrian Ebner or Sanatorio Italiano, start as the operator: contact bioaccess®. Hospital page: Hospital Italiano Asunción FIH. Program: Supira Paraguay. Clinic hub: ophthalmic FIH clinics vs CRO. Hospital hub: LATAM hospitals vs CRO. Country: Colombia, Panama.