Your independent Brazil Registration Holder.

A Brazil Registration Holder (BRH) is a Brazilian legal entity that holds your medical device registration before ANVISA and is responsible for its commercialization, post-market obligations and import authorizations. Any foreign manufacturer without a physical presence in Brazil must appoint one. Through Brazil Import Healthcare Solutions (BIHS), BRISA Advisors acts as your independent BRH, keeping your registration separate from your distributors.

Yes, but not unilaterally. Under Brazilian rules (RDC 102/2016) a registration transfer requires the cooperation of the current holder, who must sign the transfer and ask ANVISA to cancel the registration under their name; the new registration keeps the original validity date. One caveat: only Class III and IV registrations can be transferred by ownership change — notified Class I and II products must be re-submitted by the new holder. BIHS manages this process so you can consolidate registrations under an independent holder.

Brazilian Good Manufacturing Practices (BGMP) certification is required for higher-risk devices (Class III and IV) and involves an ANVISA audit of your manufacturing site. A valid Medical Device Single Audit Program (MDSAP) report is accepted by ANVISA in place of an on-site inspection, shortening the path. BIHS coordinates BGMP certification and MDSAP recognition as part of your registration.

Brazil classifies medical devices into four risk classes (I–IV) under ANVISA's RDC 751/2022, aligned with international IMDRF rules. Lower-risk Class I and II devices follow a simplified Notification (“Notificação”) path; higher-risk Class III and IV devices require full Registration (“Registro”) with a technical dossier and Good Manufacturing Practices certification. Correct classification sets your timeline, documentation and cost — BIHS confirms it before submission.

Software that performs a medical function on its own — diagnosis, monitoring or therapy — can qualify as Software as a Medical Device (SaMD). Its registration and regulation in Brazil is governed primarily by ANVISA's RDC 657/2022, while classification still follows the general risk-based framework (RDC 751/2022). It must be classified, registered and held by a Brazil Registration Holder like any physical device. BIHS handles SaMD classification and submission.