cms.bioaccessla.com

Category: Regulatory Affairs

  • 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 regulatory firm working in Central America and Panama since 2007, with its own offices in Guatemala, El Salvador and Panama. Its El Salvador page covers medical device registration dossiers and representation before the Superintendencia de Regulación Sanitaria (SRS), and explains that the importer must be registered with the SRS and named by the titular as authorized distributor.

    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 page; offices in Guatemala, El Salvador and Panama 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Its El Salvador page says the registered importer is named by the titular as authorized distributor and appoints a responsible pharmacist; Enlace provides the dossier and representation work 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 2026–Nov 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 multi-country market access 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 Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately)
    Geography Panama Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case
    Public pricing None published Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Holder vs distributor See the provider’s own terms Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    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.

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner) across Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. 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). Importer-of-record shipments are quoted separately. 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 market-access 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 Explains that a DIGEMID-authorized droguería holds the registration; helps clients set up their own droguería or evaluate registering through one that already exists 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 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Global Farma Titularidad de Registros DIGEMID vs bioaccess® LATAM Market Access

    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 Acts as the titular responsible before DIGEMID and imports through its own droguería 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 2026–Nov 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 Handles changes of manufacturer or titular before ISP and registers importers, distributors and titulares on the ISP platform; no holder product on the site 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 2026–Nov 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 regulatory firm founded by a pharmaceutical chemist. Its technical and legal representation page is aimed at foreign companies without a local structure, and at importers, distributors and establishments that need a technical role or representation before ISP or SEREMI. Ar Santé first assesses whether the operation needs representation and of what type, then defines roles, limits, signatures and responsibilities and keeps a record of changes and obligations. It says the scope of legal representation must be defined case by case and that it does not replace legal counsel.

    Ar Santé vs bioaccess®

    Dimension Ar Santé bioaccess®
    Public product Technical / legal representation before ISP and SEREMI, scoped case by case 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 Maps responsibilities between the company, the titular, the importer, the distributor and the technical professional; the page does not say Ar Santé holds the registration 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 you need help deciding which local representative role applies, Ar Santé publishes exactly that assessment.

    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 2026–Nov 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 Lists medical-device hosting (hosting de productos médicos) and registration transfers (transferencias de registros) before ANMAT 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 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Gailumed Alojamiento de Licencias LATAM vs bioaccess® LATAM Market Access

    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 Hosts registrations (alojamiento) with regulatory legal representation and registration maintenance, and separately offers a distributor search in Latin America 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 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • SPI Americas Hosting Regulatorio vs bioaccess® LATAM Registration Holder

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

    What SPI Americas publishes

    SPI Americas is a Colombia-based firm with intellectual property, corporate law and regulatory practices, active in Colombia and Latin America since 1993. Its regulatory affairs page covers INVIMA and SIC registrations, post-registration modifications, establishment inscriptions, import issues, regulatory due diligence, and translations and legalizations. It also sells a Marketing Authorization Holder (MAH) service: when a foreign company cannot hold the registration, SPI acts as holder in the countries that require it and answers to the authorities. Medical devices appear among its guides and client examples.

    SPI Americas vs bioaccess®

    Dimension SPI Americas bioaccess®
    Public product Marketing Authorization Holder (MAH) where required + INVIMA registrations, modifications and import support LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Colombia and Latin America 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Acts as registration holder in the countries that require a local holder, and represents the client before the regulatory authorities 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 Colombia is the anchor market and you also want IP or corporate counsel from the same firm, SPI Americas is a sensible pick.

    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 SPI Americas public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Pro Pharma Research COFEPRIS Titular del Registro vs bioaccess® LATAM Market Access

    Pro Pharma Research Organization shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Pro Pharma Research Organization publishes on its own site (propharmaresearch.com/index.php/servicio/servicios-representante-empresa-titular-registro-sanitario-mexico), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Pro Pharma Research Organization publishes

    Pro Pharma Research Organization is a Mexican company that publishes a service page for acting as company representative and titular del registro sanitario (TRS) before COFEPRIS. The page covers pharmaceuticals, medical devices and other health products, and COFEPRIS liaison. It is broader than devices.

    Pro Pharma Research Organization vs bioaccess®

    Dimension Pro Pharma Research Organization bioaccess®
    Public product Mexico titular del registro / company representative before COFEPRIS LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Mexico 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Acts as Titular de Registro Sanitario or company representative before COFEPRIS, and also offers distribution support (import/export logistics and local distribution requirements) 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 Mexico is the only market and you want a local titular that also handles pharma SKUs, Pro Pharma 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 Pro Pharma Research Organization public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.