Sep 30, 2020

During a recent meeting of the Collegiate Board of Directors of Brazil’s National Health Surveillance Agency (ANVISA), Emergo by UL representatives learned that ANVISA will likely decline to extend the validity period for Resolutions RDC No. 348/2020 and 349/2020 (links in Portuguese). These Resolutions had temporarily established an expedited registration scheme for IVDs, personal protective equipment (PPE), and certain medical devices used for the prevention or treatment of COVID-19.

Regulations for expedited COVID-19 registration are deemed to have served their purpose

According to the directors who spoke in the meeting, the extension of these Regulations is unnecessary because Brazil already has an adequate supply of medical devices, IVDs, and PPE to treat and diagnose COVID-19 patients. Although ANVISA has yet to issue an official statement on the matter, submissions for expedited registrations are currently no longer being accepted.

The last day on which submission of registrations through the expedited schemes was taken was on September 14 for IVDs (covered by RDC No. 348/2020) and September 16 for medical devices and PPE (per RDC No. 349/2020).

Emergency B-GMP certification procedures extended

Other regulatory procedures relating to the COVID-19 public health crisis remain in force. An amendment to Resolution RDC No. 346/2020, which established temporary Brazil Good Manufacturing Practice (B-GMP) certification procedures for products needed during the COVID-19 outbreak, extended the validity of the Resolution until Brazil’s Ministry of Health declares the health emergency to be over. The amendment was published as RDC No. 419/2020.

Learn more about Brazilian medical device regulations at Emergo by UL:

Author

  • Timothy Herr

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