Nov 20, 2019

Brazilian medical device market regulator ANVISA has outlined several near- and long-term oversight priorities pertaining to post-registration requirements, software as a medical device (SaMD), Unique Device Identification and other issues.

ANVISA announced these priorities during an event in early November commemorating 20 years of medical device regulation in Brazil; Emergo by UL consultants in Brazil attended the event and provided the following details.

Focus on post-market device modification requirements

First, ANVISA plans to publish a public consultation in 2019 to establish a new three-tier system for managing submissions of modification applications that manufacturers of Class II, III and IV devices must provide when proposing changes to their products.

  • Required modification: These changes require petitioning, technical review and publication in order to be implemented. Major impact changes such as different raw materials would fall under this category.
  • Express implementation: Low-risk changes may be implemented immediately; however, these modifications still require petitioning and should be published in Brazil’s Official Gazette even though technical reviews are not required. Changes in commercial names, for example, fall under this category.
  • Not reportable: Changes that do not require petitioning; a change of technical manager, for example, qualifies as a not-reportable modification.

Key ANVISA regulatory priorities for 2020 and beyond

Along with ANVISA’s planned change application system, the agency also listed several short- and long-term medical device regulatory priorities it plans to pursue. Key targets include:

  • Issuing a public consultation for the agency’s regulatory approach to SaMD;
  • Revisions to INMETRO Ordinance 54/16 as well as RDC 25/01 and RDC 156/06 pertaining to used and refurbished medical devices;
  • Updates to the Normative Instruction on electromagnetic compliance certification;
  • Launching a new product labeling and instructions for use uploading system to replace VisaDoc;
  • Implementing a UDI system encompassing all of the Brazilian medical device sector.

Emergo by UL will provide further updates on these initiatives as ANVISA makes them available.

Learn more about Brazilian medical device regulations:

  • ANVISA medical device registration and approval consulting
  • Brazil GMP (BGMP) quality management system compliance support
  • Brazil Registration Holder (BRH) in-country representation
  • Whitepaper: Transitioning to Medical Device Single Audit Program (MDSAP) compliance
  • Process chart: Brazil ANVISA medical device registration pathway