Brazil: ANVISA repeals coronavirus-related medical device laws

With the decreasing numbers of infections in the Public Health Emergency (PHE), the Brazilian Medical Device Market Regulator ANVISA repealed some regulations and requirements related to the Covid-19 pandemic. The Public Health Emergency of National Importance (ESPIN) has closed, with requirements of registration and importations no longer simplified and there would be no exemption from registration for pandemic-prioritized product.

Impact of RDC 702/2022 on Medical Device Manufacturers and Importers

RDC 702/2022 is published by ANVISA to repeal certain requirements that hastens market approval of devices for Covid-19 treatment during the height of the pandemic. This resolution will be implemented starting 22 May 2022.

The following are the temporary guidelines that has been repealed:

1. RDC 349/2020: Personal Protective Equipment (PPE), Ventilators and other medical devices critical to the PHE

2. RDC 375/2020: Clinical Trials for validation of Class III and IV medical devices for PHE

3. RDC 378/2020: Importation of ICU equipment for PHE

4. RDC 386/2020: Assembling, selling and donating Artificial Manual Breathing Unit (AMBU) devices

5. RDC 445/2020: Extension of shelf life for IVD devices

6. RDC 448/2020: Manufacturing, importation and selling of priority PPE Source: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=18/05/2022&jornal=515&pagina=197&totalArquivos=255 (in Portuguese language) Contact us at info@arqon.com for more information.