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ANVISA RDC

RDC 830/2023

In Vitro Diagnostic (IVD) Medical Devices
BrazilANVISARegistrationEffective June 1, 2024
Official source linked
What this code is

RDC 830/2023 is ANVISA Collegiate Board Resolution 830/2023. 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
Registration
Source links
Authority source
English
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ANVISA-hosted English text; confirm legal effect against the current official Portuguese publication.
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71 articles · 2 language versions
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-830-2023.en.html#art-1.
Dates
Published
December 11, 2023
Effective
June 1, 2024
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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 text71 articles · English — ANVISA translationRead HTML →Portuguese full text71 articles · Portuguese — official textRead HTML →
About this regulation

In Vitro Diagnostic (IVD) Medical Devices

Regulation for IVD medical devices including classification (Class I-IV), registration pathways, self-testing requirements, and companion diagnostics. Replaced RDC 36/2015.

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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