Jun 11, 2014

Brazilian medical device market regulators have initiated public consultations on proposals that could significantly reduce registration and re-registration requirements for Class I and II devices.

At a meeting with ANVISA in late May, Emergo Group was able to learn more about proposed Brazilian regulatory changes included in public consultations CP 23/2014 and CP 24/2014; the comment period on these proposals is expected to close in July 2014. Changes currently under consideration by ANVISA include:

  • Eliminating registro and cadastro requirements for Class I IVDs
  • Requiring only cadastro registration (not the more rigorous registro process) for Class I and II medical devices and Class II IVDs
  • Removing re-registration requirements for Class I and II devices
  • Allowing registration of controls, calibrators and standards as product families
  • Publishing a new regulation concerning classification and grouping for IVDs
  • Changing Technical Dossier formats to align more closely with those used in other countries
  • Evaluating submissions for IVD equipment and analyzers under ANVISA’s IVD division

It must be emphasized that these proposals have yet to be enacted, and may still change before actual implementation.  Emergo Group’s offices in Sao Paulo and Brasilia will continue monitoring developments at ANVISA and provide further details as we learn them, as well as analysis of how these regulatory changes will affect Brazilian medical device registrations going forward.

Stewart Eisenhart


  • Stewart Eisenhart