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®
| Dimension | THEMA | bioaccess® |
|---|---|---|
| Public product | Local representative / license holder in Brazil, Mexico and Argentina, inside an EU AR network | LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately) |
| Geography | Brazil, Mexico, Argentina named on the service page; Peru explainer | 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 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–Oct 2026). Claims are theirs. No invented clients, prices or contacts.
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