ANVISA medical device registration and market authorization for FDA-cleared and CE-marked products entering Brazil. bioaccess® acts as your Brazil Registration Holder (BRH) / in-country representative, prepares the ANVISA dossier, handles device classification, and coordinates the Class III/IV BGMP audit — separate from ANVISA clinical-trial authorization (RDC 837/2023).
Class I/II: notificação · Class III/IV: registro up to ~250–365 days statutory max
Brazil requires a local registration holder — the detentor de registro, also 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. bioaccess® acts as your neutral BRH through our own Brazilian entity.
All-inclusive annual subscription per country; pricing under review — contact us for a quote. The Class III/IV BGMP audit is a separate third-party certification.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
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 — under our own Brazilian entity. 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 through our own Brazilian legal entity: 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.