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ANVISA RDC

RDC 848/2024

Essential Safety and Performance Requirements
BrazilANVISARegistrationEffective September 4, 2024
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What this code is

RDC 848/2024 is ANVISA Collegiate Board Resolution 848/2024. 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).

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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88 articles · 2 language versions
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Dates
Published
March 8, 2024
Effective
September 4, 2024
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English full text88 articles · English — ANVISA translationRead HTML →Portuguese full text88 articles · Portuguese — official textRead HTML →
About this regulation

Essential Safety and Performance Requirements

Essential safety and performance requirements for medical devices and in vitro diagnostic medical devices (IVDs). Replaces the previous essential requirements framework used with RDC 751/2022.

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). Always confirm the current consolidated text and transition provisions with the official source before filing.

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