ORBIS Compliance

New ANVISA Regulation for In Vitro Diagnostic Self-Tests

Published /Brazil

Overview

ANVISA has published RDC nº 595/2022, stipulating the requirements and procedures for the registration, distribution, marketing, and use of in vitro diagnostic medical devices as self-tests for detecting SARS-CoV-2 antigen. This new regulation enables pharmacies and other regulated health retailers to sell the product directly to the population.

Importation and Approval

This regulation affects importation requirements, and approvals must be completed prior to commercialization. Legal holder companies in Brazil are required to request registration of these kits with ANVISA.

Registration Requirements

The product registration must comply with the requirements of RDC 36/205 and the specific particulars outlined in RDC 595/2022 regarding the instructions for use, labeling, customer service channels, among other stipulations.

Priority Review

Important: ANVISA will prioritize the review of registration requests for self-tests.

Contact Us

For more information or if you have questions about the regularization of self-test products for COVID-19, please contact our experts.

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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