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ANVISA RDC

RDC 665/2022

Good Manufacturing Practice (GMP) for Medical Devices
BrazilANVISAGMP/QMSEffective May 2, 2022
Official source linked
What this code is

RDC 665/2022 is ANVISA Collegiate Board Resolution 665/2022. 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
GMP/QMS
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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138 articles · 2 language versions
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Direct citations can link to an article, for example /data/regulations/brazil/rdc-665-2022.en.html#art-1.
Dates
Published
March 31, 2022
Effective
May 2, 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 text138 articles · English — ANVISA translationRead HTML →Portuguese full text138 articles · Portuguese — official textRead HTML →
About this regulation

Good Manufacturing Practice (GMP) for Medical Devices

GMP requirements for medical device manufacturers including quality management system, design controls, and production processes. Replaced RDC 16/2013.

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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