Foreign manufacturers cannot hold an ANVISA medical-device registration in their own name. They appoint a Brazilian Registration Holder (BRH) — a local PJ authorized to represent the products. Sobel Consult publishes dedicated English and Portuguese pages for that role and is explicit about what it is not: importer or distributor. That is a clean one-country BRH. This article quotes their public product, then explains when multi-country registration holding from bioaccess® is the operator instead.
What Sobel Consult publishes
English: Brazilian Registration Holder for Medical Devices. Portuguese: representante legal no Brasil para dispositivos médicos (both retrieved 23 August 2026).
Public facts on the English BRH page:
- Audience: foreign manufacturers without a Brazilian legal entity that want to commercialize devices under ANVISA.
- Steps they describe: contract and designation letter appointing Sobel as BRH; recognition with ANVISA and communications; ongoing vigilance and regulatory updates; lifecycle support for as long as the manufacturer wants the device registered.
- Two modalities: BRH with INMETRO (electrical / electromedical in INMETRO scope) and BRH without INMETRO (ANVISA representation, vigilance, and distributor qualification only).
- Related services they list: notification / registration / updates under RDC 978/2025 and RDC 658/2022; INMETRO or ANATEL support; biological evaluation aligned with ISO 10993 and ANVISA.
- FAQ: a foreign manufacturer cannot hold its own Brazilian registration. Changing BRH later is possible if the regulatory updates are performed; they say their process is built for commercial independence so distributors can change without losing the registration. Sobel does not offer importation or distribution. QMS aligned with ISO 13485 and RDC 665 is expected of the manufacturer.
That last sentence is the important one. Brazil lets the detentor de registro authorize multiple importadores under one registration (RDC 270/2019; RDC 751/2022 names a single detentor). A BRH that refuses to import is a feature for manufacturers who want interchangeable distributors. It is also a gap if the sponsor expected one party to issue import letters and sit as IOR. See Brazil — ANVISA and the IOR guide.
Sobel Consult vs bioaccess®
| Dimension | Sobel Consult | bioaccess® |
|---|---|---|
| Public product | Independent BRH / legal representative; not importer or sales | Register + hold already-cleared devices; holder/IOR under contract (own entity in Colombia; local partner elsewhere) |
| INMETRO / ANATEL | BRH with/without INMETRO; related certification support | Manages INMETRO/ANATEL and RF homologation as separate third-party work (vendor cost + 20% G&A on the market-access page); Brazil BGMP site audit likewise billed separately |
| Import | Explicitly no | ANVISA detentor can authorize multiple importers; bioaccess® holds under contract, working with its local partner in Brazil |
| Geography | Brazil | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case; certified Portuguese/Spanish translations in-house |
| Trial-to-market | Not a published FIH CRO bridge | Same firm can run the FIH trial and hold the commercial registration |
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets are quoted case by case. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. 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).
Sobel is a fair Brazil-only BRH when the manufacturer already has — or will appoint — a separate importer. bioaccess® is the operator when Brazil is one country in a multi-market hold, and when the holder must not become commercial leverage.
If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.