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 multi-country market access 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 | Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately) |
| Geography | Brazil, Mexico, Argentina named on the service page; Peru explainer | 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 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.
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 THEMA public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.