Apr 1, 2022

ANVISA, Brazil’s medical device market regulator, has published new regulations targeting software as a medical device (SaMD) set to take effect in July 2022.

ANVISA’s RDC 657/2022 (link in Portuguese) covers registration requirements for SaMD, for which Brazilian regulators had not previously issued specific rules.

Which types of medical software fall under the new ANVISA registration rules?

The new RDC 657/2022 makes clear which software types do not fall under the new regulation, such as:

  • Software for well-being of users
  • Software already listed by ANVISA as a non-regulated product
  • Software used only for administrative and financial purposes within healthcare organizations
  • Software to process demographic and epidemiological medical data without providing any diagnostic or therapeutic function
  • Software shipped within medical devices already under ANVISA surveillance

In cases where medical software is considered an accessory to a device, or in which software contains embedded medical applications, that software must undergo ANVISA registration together with its associated devices.

Requirements in terms of classification and related issues established under RDC 185/2001 as well as other relevant medical device regulations will apply for SaMD, as well. SaMD products registered with ANVISA will be subject to auditing, market monitoring, surveillance and inspections by the regulator.

ANVISA plans to put RDC 657/2022 into effect starting July 1, 2022.

Additional Brazilian medical device and SaMD regulatory resources from Emergo by UL:

Author

  • Stewart Eisenhart

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