Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Description

Brazilian Health Regulatory Agency is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office. It is responsible for the regulation and approval of pharmaceutical drugs, sanitary standards and regulation of the food industry.

Official website

http://antigo.anvisa.gov.br/en/english

Alerts

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Find the alerts published by Anvisa on products subject to health surveillance

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Normative Instruction - IN no. 290 of 04/04/2024

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Establishes, under the terms of Collegiate Board Resolution - RDC No. 741, of August 10, 2022, an optimized procedure for the analysis and decision of medical device registration petitions, through the use of analyses carried out by an Equivalent Foreign Regulatory Authority (AREE).

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Updated on April 8, 2024

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Normative Instruction - IN nº 283 of 07/03/2024

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Approves the list of Technical Standards for the certification of conformity of equipment under the Health Surveillance regime

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Updated on March 8, 2024

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Collegiate Board Resolution - RDC No. 848 of 06/03/2024

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Provides for the essential safety and performance requirements applicable to medical devices and in vitro diagnostic (IVD) medical devices.

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Updated on March 8, 2024

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Collegiate Board Resolution - RDC No. 837 of 13/12/2023

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Provides for clinical investigations with medical devices in Brazil.

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Updated on December 15, 2023

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Collegiate Board Resolution - RDC No. 830 of 06/12/2023

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments.

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Updated on December 11, 2023

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Guide no. 44 version 3 of 30/10/2023

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Guide to the Specification of Documentation for the Electronic Petitioning of Medical Devices

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Updated on December 6, 2023

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Collegiate Board Resolution - RDC No. 825 of 26/10/2023

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Establishes the minimum identity and quality requirements for surgical gloves and gloves for non-surgical procedures made of natural rubber, synthetic rubber, a mixture of natural and synthetic rubbers and polyvinyl chloride, under the health surveillance regime.

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Updated on October 30, 2023

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Collegiate Board Resolution - RDC No. 810 of 17/08/2023

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Amends Collegiate Board Resolution - RDC No. 751, of September 15, 2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices.

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Updated on August 18, 2023

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Guide No. 63 version 1 of 25/07/2023

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Guide to Biological Safety Assessment of Nanotechnology-based Materials for Health Use

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Updated on August 4, 2023

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Ordinance - PRT No. 511 of 30/09/2021

From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Defines the chronological criteria for analysis or approval of registration or notification processes for products defined as medical devices, within the scope of the National Health Surveillance Agency.