SUBMIT INQUIRY
Brazil
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
Medical devices are regulated by ANVISA (Agência Nacional de Vigilância Sanitária, or the Health Surveillance Agency)

CLASSIFICATION SYSTEM: Devices are classified according to a risk based model of Classes I, II, III and IV.

TIMEFRAME: There are two different pathways for registration: cadastro for Class I and II devices and registro for Class III and IV devices. Approval takes only 4-6 months for the cadastro process. For the registro process, an ANVISA audit is required, after which registration takes an additional 8-10 months. 

LICENSE VALIDITY: Licenses issued in Brazil expire after five years. 

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Brazil.

Last updated on April 6, 2017.



Interested in obtaining fast market approval for your medical device or IVD in Brazil? REQUEST A FREE QUOTE>

For more information on registration in Brazil, check out the following articles on our blog:
Country at a Glance: Brazil
3 Ways Registration in Brazil is Improving
3 More Ways Registration in Brazil is Improving
 
latest news
  • Oct 3 2018
    REGULATORY UPDATE - LABORIE

    China: Laborie's Aquarius System was approved for sale with LICENSALE.COM®. ...

    Read More
  • Sep 28 2018
    REGULATORY UPDATE - VAREX IMAGING CORP.

    Canada: Varex Imaging's Nexus DR was approved for sale with LICENSALE.COM®....

    Read More
  • Sep 12 2018
    REGULATORY UPDATE - TECHNOPATH CLINICAL DIAGNOSTICS

    Canada: Technopath Clinical Diagnostics' Multichem A1C was approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 16 2018
    REGULATORY UPDATE - VIASONIX

    Canada: Viasonix' Dolphin family of products was approved for sale with LICENSALE.COM®....

    Read More
  • Aug 8 2018
    REGULATORY UPDATE - ORASURE TECHNOLOGIES

    Nepal: OraSure Technologies' OraQuick HIV Self-Test was approved for sale with LICENSALE.COM®....

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP