ANVISA – COLLEGIATE BOARD RESOLUTION – RDC Nº 657, OF MARCH 24, 2022: Provides for the regularization of software as a medical device (Software as a Medical Device – SaMD)
ANVISA published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION – RDC No. 657, OF MARCH 24, 2022, which provides for the regularization of software as a medical device (Software as a Medical Device – SaMD), a milestone for the software market in Brazil, as it is ANVISA’s first RDC that deals exclusively with this product category.
Effective from July 1, 2022, RDC 657/2022 establishes the requirements for the regularization of software as a medical device (Software as a Medical Device – SaMD), defined as Software that meets the definition of a medical device, may be in vitro diagnostics (IVD) or not, being intended for one or more medical indications, and which accomplish those purposes without being part of medical device hardware. Includes mobile applications and software for in vitro purposes, if their indications are included in the general definition of medical devices. This definition includes, among others, software licensed by subscription and centrally hosted (Software as a Service), which meets the definition of medical devices.
According to RDC 657/2022, software with medical applications that are considered accessories for the exclusive use of medical devices and software with embedded medical applications must be regularized together with the medical devices under the associated health surveillance regime. In addition, SaMD must be framed in the rules and classes according to the Collegiate Board Resolution – RDC No. 185, of October 22, 2001, or subsequent regulations.
For SaMD for in vitro, notwithstanding the risk classification of SaMD for in vitro, its regularization must follow the other rules in accordance with the Resolution of the Collegiate Board of Directors – RDC No. 185, of October 22, 2001, or subsequent regulations.
The SaMD developed internally (in house) by the health service and for the exclusive use of the health service, head office or branches, which fall into risk classes I and II, will not be subject to regularization at Anvisa, as long as they do not interfere with the functioning of medical devices subject to regularization, being prohibited their commercialization or donation of the SaMD developed internally, without proper regularization at Anvisa.
Finally, the regularization of a SaMD must follow the general provisions of medical devices, in particular the Collegiate Board Resolution – RDC nº 185, of October 22, 2001, and the Collegiate Board Resolution – RDC nº 40, of August 2015, including its updates, and the manufacturer is not allowed to commercialize, in the form of licensing or equivalent, or to make the SaMD or its updates available to new users with expired or canceled regularization.
Link to access RDC 657/2022 in portuguese, click here.
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