May 20, 2022

Brazilian medical device market regulator ANVISA announced the repeal of several regulations and requirements related to the COVID-19 pandemic which have been deemed no longer necessary due to the lower numbers of infections in the Public Health Emergency (PHE). The news (link in Portuguese) was reported in Brazil’s Diário Oficial Da União.

As a consequence of the closure of the Public Health Emergency of National Importance (ESPIN) by the Brazilian Minister of State for Health, there is no longer a need for the simplification of requirements for registration or importation, or exemption from registration for pandemic-prioritized products.

What impact will RDC 702/2022 have on medical device manufacturers and importers?

ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to treat patients during the height of the COVID-19 pandemic.

The resolution RDC 702/2022 repeals the following:

  • RDC 349/2020: the temporary criteria and procedures for regularization of personal protective equipment (PPE), ventilators and other medical devices ANVISA identified as critical to the PHE.
  • RDC 375/2020: extraordinary/temporary procedures for submission of clinical trials used for the validation of class III and IV medical devices due to PHE.
  • RDC 378/2020: temporary procedures for import of used ICU equipment due to PHE.
  • RDC 386/2020: assembly, sale and donation of Artificial Manual Breathing Unit (AMBU) devices.
  • RDC 445/2020: special consent for retroactive application of extended shelf life for IVD devices.
  • RDC 448/2020: temporary requirements for manufacture, import and sale of priority PPE.

The resolution RDC 702/2022 becomes effective on May 22, 2022.

What medical device manufacturers and importers should do to respond to RDC 702/2022

According to Luiz Levy, Director of QA/RA at Emergo by UL in Brazil, the best approach is to be prepared. “Now manufacturers will need to comply with all registration and importation requirements associated with medical device regulations in Brazil,” Levy advised.

Emergo by UL will post updates on new Brazilian medical device resolutions as they become available.

Learn more about Brazil’s medical device regulations from Emergo by UL:
 

  • Brazil ANVISA regulatory approval process chart
  • Brazil ANVISA Registration Holder service for medical device companies
  • Brazil ANVISA medical device classification consulting
  • Brazil Good Manufacturing Practice (B-GMP) compliance consulting
  • Brazil medical device approval and ANVISA registration service
  • Brazil emergency use pathways for medical devices and IVDs service
  • Brazil's medical device regulatory update webinar

 

Author

  • Kathryn Burke's picture
    Kathryn Burke

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