Author: Julio Martinez-Clark

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®

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 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®

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 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®

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 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®

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 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®

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.

PharmaLex (Cencora) shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what PharmaLex (Cencora) publishes on its own site (www.pharmalex.com/pharmalex-industry-sectors/medtech · www.pharmalex.com/pharmalex-solutions/local-affiliate-services), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

What PharmaLex (Cencora) publishes

PharmaLex, part of Cencora, is a global regulatory consultancy that says it has 60+ offices in 32 countries. Its MedTech page says it arranges authorized-representative services in "multiple markets" and manages the product licenses, and its local-affiliate page names emerging Latin American markets "such as Brazil and Mexico." The public pages do not list INVIMA, ANMAT, ISP or DIGEMID holder services one by one, and much of the MedTech content is EU MDR/IVDR work.

PharmaLex (Cencora) vs bioaccess®

Where each one fits

If you are a large manufacturer already buying EU MDR and pharmacovigilance work from PharmaLex, adding Brazil or Mexico through the same account is fine.

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

Registrar Corp (CMC Medical Devices) shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Registrar Corp (CMC Medical Devices) publishes on its own site (www.registrarcorp.com/medical-devices/global-representation · www.registrarcorp.com/contact/mexico-office), then compares it with multi-country market access from bioaccess®. It is a practitioner comparison, not a teardown.

What Registrar Corp (CMC Medical Devices) publishes

Registrar Corp is a long-standing U.S. FDA-compliance firm that works with CMC Medical Devices on global representation. Its representation page lists Europe, the UK, Switzerland, Australia, China, the US, India, Korea, Southeast Asia and "South America." We found no country pages naming ANVISA, COFEPRIS, INVIMA or ANMAT holder services. Registrar Corp does publish a Mexico office contact page.

Registrar Corp (CMC Medical Devices) vs bioaccess®

Where each one fits

If you need one vendor for US Agent, EU, UK, Swiss and Asian representation and Latin America is a later thought, Registrar Corp is a reasonable global bundle.

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 Registrar Corp (CMC Medical Devices) public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

Global Regulatory Partners (GRP) shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Global Regulatory Partners (GRP) publishes on its own site (globalregulatorypartners.com/registration-holder-for-medical-devices-imported-from-mexico · globalregulatorypartners.com/countries/brazils-anvisa), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

What Global Regulatory Partners (GRP) publishes

Global Regulatory Partners (GRP) is a Massachusetts regulatory firm with affiliates in China, Japan, Brazil and Mexico. Its public pages say GRP-Brazil is licensed by ANVISA to act as Brazilian Registration Holder, and that GRP Mexico is COFEPRIS-licensed to act as Mexico Registration Holder and local representative. The Mexico page pitches an independent holder, so a manufacturer can add distributors without handing them the dossier, and also lists importation, warehousing and distribution.

Global Regulatory Partners (GRP) vs bioaccess®

Where each one fits

If Brazil and Mexico are the only Latin American markets on the plan, and you also want GRP for China or Japan, its own-affiliate model covers 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 Global Regulatory Partners (GRP) public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

THEMA shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what THEMA publishes on its own site (www.thema-med.com/en/services/local-representative-and-license-holder · www.thema-med.com/en/medical-device-registration-argentina), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

What THEMA publishes

THEMA is an Italy-based medical-device consultancy. Its local representative and license holder service page names three Latin American roles it offers: Brazilian Registration Holder (BRH), Mexican Registration Holder (MRH), and Argentina Authorized Representative (AAR). It also publishes a Peru registration explainer that describes the DIGEMID local holder. THEMA offers local representation and license holding "where required" as part of a wider EU authorized-representative network. Its Argentina page warns that changing the AAR means restarting the registration, which is the honest description of how ANMAT works.

THEMA vs bioaccess®

Where each one fits

If you already use THEMA as your EU authorized representative and need one or two of Brazil, Mexico or Argentina, keeping the same vendor is a fair choice.

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

IzzoMed is a Lima-based company that now publishes an independent Peru registration holder offer for international medical device, IVD, and pharmaceutical manufacturers. The English page is at izzomed.com/peru-registration-holder/ and the Spanish version is at izzomed.com/es/titular-del-registro-en-peru/. The English holder page went live in late September 2026. This article uses only what IzzoMed publishes, then compares it with multi-country market access from bioaccess®.

What IzzoMed publishes

IzzoMed positions itself as a local regulatory representative and registration holder before DIGEMID, Peru’s medicines and devices authority. The holder page lists four parts: local regulatory representation, registration management, registration maintenance (renewals and modifications), and a holder structure that “can remain independent from commercial distribution.” The home page adds importation, storage through authorized healthcare infrastructure, distribution, and commercial development in Peru. IzzoMed also represents specialized oncology equipment in Peru on its own product pages. We found no public price on the site.

The pitch is the right one for Peru. As summarized in the bioaccess® LATAM registration guide, Decreto Supremo N° 001-2024-SA permits an independent Peru registration holder, and imports still flow through a licensed droguería. A titular that is not the exclusive seller lets the manufacturer change or add distributors without losing the registro.

IzzoMed vs bioaccess®

Where each one fits

If Peru is the only market and the plan is to build a local commercial channel with one partner, IzzoMed’s published offer covers that job, and it says the right things about keeping the titular separate from the seller.

bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract across Latin America (in Colombia through its own Colombian entity; elsewhere with its local partner). The bioaccess® Peru Holder covers DIGEMID registration through the licensed droguería pathway, and the same holder doctrine applies next to COFEPRIS, ANVISA, INVIMA, and ANMAT. 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). Import 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 a local titular is enough? Hire the shop that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, try the market-access calculator, or request a registration quote.