---
title: "Regulatory Update: Brazil"
description: Regulatory Update for Brazil, November 2023
image: https://blog.arazygroup.com/hubfs/imgpsh_fullsize_anim-Nov-06-2023-11-01-11-6389-PM.jpg
---

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# Regulatory Update: Brazil

[Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group)

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On August 17, 2023, the National Health Surveillance Agency in Brazil (ANVISA) published the Resolution - RDC No. 810 for risk classification, notification, registration regimes, and labeling requirements and instructions for the use of medical devices.

The resolution outlines that the import of medical devices, including their accessories, is permitted even if their manufacturing dates precede the notification or registration publication dates, provided that the period does not exceed 5 (five) years and that such products are in strict accordance with the conditions for approval with ANVISA.

Find the full (Spanish) resource [here](https://www.in.gov.br/web/dou/-/resolucao-rdc-n-810-de-17-de-agosto-de-2023-503893646).

 

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