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 the multi-country holder subscription 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 through own entities |
| 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 outside the flat fee |
| Import | Explicitly no | ANVISA detentor can authorize multiple importers; bioaccess® holds through its own Brazilian entity |
| Geography | Brazil | 19 LATAM markets; gov fees + certified Portuguese/Spanish translations included |
| Trial-to-market | Not a published FIH CRO bridge | Trial-to-Market Bridge 20% for bioaccess® clinical-trial clients |
The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.
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, when translations and government submission fees should sit inside the annual fee, 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.
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