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Category: Market Access Services in Latin America

Explores the regulatory requirements and best practices for obtaining marketing authorization, market clearance, and regulatory registrations in the top Latin American countries—Mexico’s Cofepris, Colombia’s Invima, Brazil’s Anvisa, and Argentina’s Anmat—market entry, and market access in Latin America, focusing on innovative medical devices.

  • Aruna Asesores LATAM Device Registration vs bioaccess® Registration Holder

    Aruna Asesores shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Aruna Asesores publishes on its own site (arunasesores.com/chile-dispositivos-medicos), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Aruna Asesores publishes

    Aruna Asesores is a Colombian regulatory firm that publishes country pages for device registration in other Latin American markets, such as its Chile ISP medical devices page. The pages describe dossier and filing work. They do not present a holder product.

    Aruna Asesores vs bioaccess®

    Dimension Aruna Asesores bioaccess®
    Public product Multi-country device dossiers (e.g. Chile ISP) LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Colombia-based; country pages for other markets 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you have local holders lined up and need one firm to prepare dossiers in several countries, Aruna's model fits.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Aruna Asesores public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • MacroBridge Registro Sanitario DIGEMAPS vs bioaccess® LATAM Registration Holder

    MacroBridge shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what MacroBridge publishes on its own site (macro-bridge.com/servicios/registro-sanitario), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What MacroBridge publishes

    MacroBridge is a Dominican Republic firm whose registro sanitario page covers DIGEMAPS dossiers for many product classes, including medical devices and health equipment. It does not describe itself as a third-party holder.

    MacroBridge vs bioaccess®

    Dimension MacroBridge bioaccess®
    Public product DIGEMAPS dossier across product classes LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Dominican Republic 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If your Dominican distributor will be the holder and you only need DIGEMAPS paperwork, MacroBridge fits.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the MacroBridge public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Enlace Profesional Registro Sanitario de Dispositivos Médicos en El Salvador vs bioaccess®

    Enlace Profesional de Consultores shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Enlace Profesional de Consultores publishes on its own site (enlacegt.com/registro-sanitario/registro-sanitario-de-dispositivos-medicos-en-el-salvador), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Enlace Profesional de Consultores publishes

    Enlace Profesional de Consultores is a Guatemala-based regional regulatory firm. Its El Salvador page covers medical device registration dossiers and representation before the Superintendencia de Regulación Sanitaria (SRS).

    Enlace Profesional de Consultores vs bioaccess®

    Dimension Enlace Profesional de Consultores bioaccess®
    Public product SRS dossier + representation LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography El Salvador (Guatemala-based regional firm) 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Central America is the whole plan and you want a Guatemala-based firm, Enlace publishes that service.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Enlace Profesional de Consultores public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Registra en Panamá Registro Sanitario de Dispositivos Médicos vs bioaccess®

    Registra en Panamá shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Registra en Panamá publishes on its own site (registraenpanama.com/registros-sanitarios-de-dispositivos-medicos), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Registra en Panamá publishes

    Registra en Panamá publishes a medical device registration page covering MINSA device registration and operating licenses. It is a dossier and permits service, and the page does not say the firm becomes the named holder.

    Registra en Panamá vs bioaccess®

    Dimension Registra en Panamá bioaccess®
    Public product MINSA device registration dossier + operating license LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Panama 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you already have a Panamanian distributor who will hold the registration, a permits shop like Registra en Panamá is enough.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Registra en Panamá public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • MD Consultora Registro Sanitario Perú vs bioaccess® LATAM Registration Holder

    MD Consultora shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what MD Consultora publishes on its own site (mdconsultora.pe/como-obtener-un-registro-sanitario), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What MD Consultora publishes

    MD Consultora is a Peruvian consultancy that publishes a guide on how to obtain a registro sanitario. It offers dossier work and droguería setup, and in replies on the page says it can evaluate registering and importing through an already-constituted droguería. It does not have a dedicated holder product page.

    MD Consultora vs bioaccess®

    Dimension MD Consultora bioaccess®
    Public product DIGEMID dossier + droguería setup LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Peru 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you plan to set up your own Peruvian droguería, a consultancy that does droguería setup is the right first call.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the MD Consultora public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Global Farma Titularidad de Registros DIGEMID vs bioaccess® LATAM Launch Subscription

    Global Farma shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Global Farma publishes on its own site (globalfarma.pe/services/titularidad-de-registros), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Global Farma publishes

    Global Farma is a Peruvian company whose titularidad de registros page offers to hold registrations for pharmaceuticals, cosmetics, medical devices and sanitary products, and to import through its own droguería.

    Global Farma vs bioaccess®

    Dimension Global Farma bioaccess®
    Public product DIGEMID registration holder + import through its droguería LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Peru 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Peru is the only market and you want the titular and the importing droguería in one local company, Global Farma covers it.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Global Farma public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Mi Regulatorios ISP Chile Registration vs bioaccess® LATAM Registration Holder

    Mi Regulatorios shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Mi Regulatorios publishes on its own site (miregulatorios.cl), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Mi Regulatorios publishes

    Mi Regulatorios is a Chilean regulatory practice led by María Inés Silva. Its homepage covers ISP registrations for cosmetics, medical devices, pharmaceuticals and disinfectants, company inscription and warehouse (bodega) resolutions. It is a dossier service, and the site does not present a separate holder product.

    Mi Regulatorios vs bioaccess®

    Dimension Mi Regulatorios bioaccess®
    Public product ISP dossiers, company inscription, bodega resolution LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Chile 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you already have a Chilean importer and only need the ISP paperwork done, a dossier shop like Mi Regulatorios is the right size.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Mi Regulatorios public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Ar Santé Representación Técnica y Legal ISP Chile vs bioaccess® Registration Holder

    Ar Santé shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Ar Santé publishes on its own site (arsante.cl/servicios/representacion-tecnica-legal), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Ar Santé publishes

    Ar Santé is a Chilean firm whose technical and legal representation service puts a qualified pharmacist or technician in front of ISP and SEREMI to sign filings for foreign companies that have no local professional. The page does not say Ar Santé holds the registro sanitario itself, but it is the company's in-country face.

    Ar Santé vs bioaccess®

    Dimension Ar Santé bioaccess®
    Public product Technical / legal representative before ISP and SEREMI LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Chile 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Chile is the only market and what you need is a qualified local signatory, Ar Santé publishes exactly that.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Ar Santé public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • D-UP Hosting de Productos Médicos ANMAT vs bioaccess® LATAM Registration Holder

    D-UP Consultoría Regulatoria y Calidad shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what D-UP Consultoría Regulatoria y Calidad publishes on its own site (d-up.com.ar), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What D-UP Consultoría Regulatoria y Calidad publishes

    D-UP is an Argentine regulatory and quality consultancy. Its homepage lists hosting de productos médicos, company habilitaciones, registration of local and imported products, and registration transfers before ANMAT, alongside a broader pharma and quality practice.

    D-UP Consultoría Regulatoria y Calidad vs bioaccess®

    Dimension D-UP Consultoría Regulatoria y Calidad bioaccess®
    Public product ANMAT hosting de productos médicos + habilitaciones + transfers LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Argentina 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Argentina is the only market and you also need quality-system support there, D-UP's hosting service fits.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the D-UP Consultoría Regulatoria y Calidad public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Gailumed Alojamiento de Licencias LATAM vs bioaccess® LATAM Launch Subscription

    Gailumed shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Gailumed publishes on its own site (gailumed.com/servicios-para-america-latina), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Gailumed publishes

    Gailumed publishes a Latin America services page that offers to register products, host ("alojar") the licenses, and act as legal representative across the region. Medical devices are listed among other health product classes.

    Gailumed vs bioaccess®

    Dimension Gailumed bioaccess®
    Public product Registration + license hosting + legal representation LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Multi-country Latin America (countries per its services page) 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor See the provider’s own terms Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If your portfolio mixes devices with other health products and you want one hosting vendor for all of them, Gailumed advertises that job.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Gailumed public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.