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ANVISA RDC

RDC 657/2022

Software as Medical Device (SaMD)
BrazilANVISASoftware/SaMDEffective July 1, 2022
Official source linked
What this code is

RDC 657/2022 is ANVISA Collegiate Board Resolution 657/2022. A Collegiate Board Resolution is ANVISA’s primary binding regulation. The number is sequential within the year (RDC 751/2022 is resolution 751 issued in 2022).

Instrument
RDC
Full name
Resolução da Diretoria Colegiada
Category
Software/SaMD
Source links
Authority source
English
Open the issuing-authority text
ANVISA-hosted English text; confirm legal effect against the current official Portuguese publication.
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25 articles · 2 language versions
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-657-2022.en.html#art-1.
Dates
Published
March 30, 2022
Effective
July 1, 2022
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

English full text25 articles · English — ANVISA translationRead HTML →Portuguese full text25 articles · Portuguese — official textRead HTML →
About this regulation

Software as Medical Device (SaMD)

Requirements for regularizing Software as a Medical Device (SaMD), including classification, technical documentation, software validation, cybersecurity, labeling, and post-market responsibilities.

A Collegiate Board Resolution is ANVISA’s primary binding regulation. The number is sequential within the year (RDC 751/2022 is resolution 751 issued in 2022). Always confirm the current consolidated text and transition provisions with the official source before filing.

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