The Brazilian Agencia Nacional de Vigilancia Sanitaria (ANVISA) is the competent authority for medical devices in Brazil. All products must be registered with ANVISA before sold in the Brazilian market. Medical devices are divided into one of the four classes: I, II, III and IV. In vitro diagnostic devices are divided into six different groups comprising of a total of 87 families of devices.
To register a medical device with the Brazilian Ministry of Health, the manufacturer must have an office in Brazil or have a local distributor in Brazil who is authorized by the Brazilian authorities to import and distribute medical devices. Our country specific (*) regulatory services in Brazil include:
Medical Device specific regulation strategy reports, Medical Device Registration with ANVISA, Brazilian Representative and certification holder for Medical Device manufacturers, ANIVISA Technical documents Preparation, B-GMP audit compliance and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Brazil!
(*) Brazilian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.
