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ANVISA RDC

RDC 591/2021

Unique Device Identification (UDI) System
BrazilANVISAUDIEffective January 10, 2022
Official source linked
What this code is

RDC 591/2021 is ANVISA Collegiate Board Resolution 591/2021. 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
UDI
Source links
Authority source
Portuguese
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Authority publication; confirm whether a later amendment or consolidated version applies.
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19 articles · 1 language version
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-591-2021.pt.html#art-1.
Dates
Published
December 29, 2021
Effective
January 10, 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.

Portuguese full text19 articles · Portuguese — official textRead HTML →
About this regulation

Unique Device Identification (UDI) System

Brazil's UDI system requiring unique identifiers, machine-readable and human-readable labeling, and submission to ANVISA's UDI database. Implementation deadlines were later amended by RDC 884/2024.

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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