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ANVISA RDC

RDC 551/2021

Field Safety Corrective Actions Notification
BrazilANVISAVigilanceEffective October 1, 2021
Official source linked
What this code is

RDC 551/2021 is ANVISA Collegiate Board Resolution 551/2021. 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
Vigilance
Source links
Authority source
Portuguese
Open the issuing-authority text
Authority publication; confirm whether a later amendment or consolidated version applies.
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20 articles · 1 language version
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-551-2021.pt.html#art-1.
Dates
Published
August 31, 2021
Effective
October 1, 2021
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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 text20 articles · Portuguese — official textRead HTML →
About this regulation

Field Safety Corrective Actions Notification

Requires registration holders to execute and notify field safety corrective actions, including recalls, corrections, and safety communications to ANVISA and healthcare facilities.

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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