ANVISA medical device registration and Brazil Registration Holder (BRH) for FDA-cleared and CE-marked products. Separate from ANVISA trial authorization.
Class I/II: notificação · registro: statutory max ~250 days (equipment), 320 (materials), 365 (IVD) (ANVISA (gov.br), prazos legais de registro) statutory max
Brazil requires a local registration holder — the detentor de registro, often called the Brazil Registration Holder (BRH) or in-country representative. The holder can add multiple importers to a single ANVISA registration, but only with the holder's cooperation, so distributors that hold your registration have practical leverage to block transfers. bioaccess® acts as your neutral BRH / in-country representative under its contract with you, working with our local partner in Brazil, so you can change or add distributors at any time. See the full country-by-country breakdown on our LATAM Importer of Record guide.
Tecnovigilancia is not a PMS add-on. Brazil’s detentor do registro must answer ANVISA on AEs, complaints, and field actions (RDC 67/2009 art. 3) through a named detentor system and the NOTIVISA duty. If that system fails, the authority can suspend or cancel the registro, seize or freeze product, or prohibit use. A device without a live registro cannot legally stay on the market. bioaccess® is the BRH and runs that system as holder under the annual holder fee.
Two-part pricing for Brazil: a one-time registration fee of $6,750 (ANVISA Class I/II) or $22,250 (ANVISA Class III/IV), then an annual holder fee from year 2 of $6,000 (Class I/II) or $7,500 (Class III/IV). The registration fee includes initial government fees and certified/sworn translations up to a stated cap, and the first 12 months of holder service; see /market-access#pricing for caps and exclusions. USD, excluding VAT and local taxes; valid for agreements signed by 31 March 2027. Brazil BGMP, INMETRO and ANATEL are not included and are quoted separately.
Technovigilance included: The annual holder fee includes technovigilance: adverse-event reporting to ANVISA, field safety actions (agency notification and relaying the field-safety notices you issue; executing a recall is quoted separately), and agency correspondence.
Two separate ANVISA workstreams. Clinical-trial authorization lets you run an investigation — CEP ethics review (CONEP only where still required), the investigational-device import permit, and the clinical-investigation dossier under RDC 837/2023. Device registration (market authorization) lets you sell — the registro/notificação dossier under RDC 751/2022, anchored by an in-country registration holder. bioaccess® runs both.
bioaccess® prepares and submits the ANVISA registration dossier — technical file, essential-principles and labeling documentation, sworn Portuguese translation of IFU and labels — with our local partner in Brazil. Class III/IV devices additionally require a separate BGMP manufacturing-site audit.
ANVISA registrations must be anchored by a local detentor de registro — the Brazil Registration Holder (BRH) / in-country representative. bioaccess® serves as your neutral BRH under its contract with you, working with our local partner in Brazil: you keep FDA/CE ownership, and importers can be named or changed under the registration without re-registering the device.
Under ANVISA’s risk-based rules (RDC 751/2022), Class I–II devices generally follow a notificação route and Class III–IV a full registro. Classification sets dossier requirements, review depth, and whether the Class III/IV BGMP audit applies. bioaccess® confirms the ANVISA class first.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Brazil.