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ANVISA RDC

RDC 67/2009

Technovigilance Rules for Medical Devices
BrazilANVISAVigilanceEffective December 23, 2009
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What this code is

RDC 67/2009 is ANVISA Collegiate Board Resolution 67/2009. 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
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17 articles · 1 language version
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-67-2009.pt.html#art-1.
Dates
Published
December 23, 2009
Effective
December 23, 2009
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Portuguese full text17 articles · Portuguese — official textRead HTML →
About this regulation

Technovigilance Rules for Medical Devices

Establishes technovigilance rules for medical device registration holders in Brazil. Defines adverse event reporting requirements, timelines, and post-market surveillance procedures.

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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