BRAZIL (ANVISA) Medical Device Registration

Brazil is the largest medical device market in Latin America, with an established but complex regulatory system. Medical devices in Brazil are regulated by the National Health surveillance agency (ANVISA).

With Partner offices in Brazil, Lexium’s team in Brazil has the expertise to help you navigate ANVISA’s regulatory requirements and begin selling your device in Brazil .

    Brazil Registration Partner

    Foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazil Registration Holder (BRH), your BRH will submit your registration application to ANVISA and maintains control of your device registration and Brazil Good Manufacturing Practice (B GMP) certification, if applicable. Hiring an independent BRH instead of a distributor gives you freedom to change distributors at any time.

    INMETRO Certification Requirement

    ANVISA requires certain medical devices be certified by the National Institute of Metrology, standardization and industrial quality (INMETRO) which is responsible for the establishment of technical standards in Brazil, INMETRO certification is often required for electro medical devices subject to IEC 60601, as well as some other medical devices. Lexium can assist with the selecting of INMETRO certifier and communicate with them on your behalf.

    Let Lexium assist you with your Brazils’s Regulatory Approval Process

    Lexium assists manufacturers to identify the device classification as a first step. Lexium helps client in procuring certification such as INMETRO and BGMP by helping in rectifying the regulatory hassles involved. Our partner companies are having vast experience in launching numerous devices in the region.

      Post Approval Services

      Lexium supports the foreign manufacturers in start to end medical device life cycle management, including post approval activities such as:

    • Post approval change management, modifications to existing medical device approvals such as addition of new variants, accessories & addition of new indications of use among others.
    • Maintenance of approvals and registration through timely payment of administrative & registration fees.
    • Renewal of License
    • Liaison between ANVISA and the Manufacturer
    • Importation Arrangement

      Lexium Expertise
    • Regulatory Due Diligence Services
    • Official Classification Services
    • BGMP Certification Services
    • MDSAP Certification
    • INMETRO Certification
    • Economic Information Report (EIR) Services
    • Device Registration Through Notificacao and Registro Pathways
    • Brazilian Registration Holder(BRH) Services
    • Translation Services
    • Labelling Services
    • Distributor Identification & Qualification Services
    • Operating Permits and Authorization
    • Post Approval Change Management
    • License Renewal and Transfer Services

    Ready to get started – Request a free consultation