In-country Representation: Brazilian Registration Holder

In-country Representation: Brazilian Registration Holder

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Brazilian legislation mandates that only national companies with local and federal sanitary licenses can register medical devices. The authorized representative, or Brazilian Registration Holder (BRH) assumes responsibility for your device registration in Brazil, serving as the intermediary between your company and ANVISA. Appointing an independent ANVISA representative provides greater flexibility and control over your registration compared to appointing a distributor. Brazilian law permits the registration holder to issue import permits, authorizing chosen distributor(s) to import your devices, granting you full control over the process. DOMO Salute meets all legal and technical requirements to host medical device, SaMD and IVD registries, serving as your in-country representative before ANVISA and managing all regulatory procedures. Our services encompass registration control, surveillance, and adverse event reporting, always prioritizing your company's interests in Brazil. Choosing DOMO as your BRH eliminates the need to select a distributor beforehand. You can initiate the registration process while familiarizing yourself with the Brazilian market and potential distributors.
DOMO Salute ConsultoriaE-185We specialize in regulatory consulting and serve as Brazilian Registration Holders (BRH) for medical devices, Software as a Medical Device (SaMD), and in vitro diagnostic (IVD) products. Our mission is to simplify the complexities of the Brazilian regulatory system, facilitating market entry for manufacturers. We prioritize understanding your unique needs and establishing clear and comfortable communication channels to ensure transparency and confidence throughout the process. Leveraging our team's expertise, we tailor regulatory strategies for medical devices, delivering efficient and timely services. * Somos consultoria regulatória dedicada a orientar fabricantes de dispositivos médicos, Software como Dispositivo Médico (SaMD) e produtos para diagnóstico in vitro (IVD) através das complexidades do sistema regulatório brasileiro, facilitando sua entrada em nosso mercado em expansão. Nossa abordagem envolve dedicar tempo para compreender suas necessidades específicas e estabelecer uma comunicação fluida e eficaz, garantindo clareza e segurança durante todo o processo. Com a expertise de nossa equipe, adaptamos a abordagem regulatória para dispositivos médicos, oferecendo serviços eficientes e pontuais.

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