Medical Device Registration in Brazil - Part I - The Role of ANVISA and BRH скачать в хорошем качестве

Medical Device Registration in Brazil - Part I - The Role of ANVISA and BRH

This video is the first of a three-part Freyr Video Cast Series on Medical Device Registration in Brazil. Medical Devices in Brazil are regulated by Agencia Nacional de Vigilancia Sanitaria (ANVISA) functioning under The Brazilian Ministry of Health (Ministério da Saúde). To register their Medical Devices in Brazil, manufacturers and suppliers must ensure their products meet the requirements laid down by the National Health Surveillance Agency – ANVISA. Foreign manufacturers who intend to market their Medical Devices in Brazil must appoint a Brazilian Registration Holder (BRH), i.e. an Authorized Local Representative responsible for submitting to ANVISA the necessary documents for the registration procedure. Freyr extends auxiliary support for manufacturers with Device Classification, conformity assessment for certification and extends support throughout the Regulatory process. Freyr provides manufacturers with Regulatory support to acquire Brazilian Good Manufacturing Process (BGMP) Certification, procure INMETRO Certification, Document Compilation for Cadastro and Registro Processes and effectively handles the post-marketing surveillance activity of Medical Devices in Brazil. For more info, Please visit: https://www.freyrsolutions.com/medica...