Throughout RDC 595/2022, ANVISA has established on the 28th of January the requirements for SARS-CoV-2 antigen self-test’s registration, distribution, commercialization and usage. The Resolution allows pharmacies and other healthcare companies to sell COVID-19 self-test kits directly to the population.

Here are a few highlights on the requirements:

– COVID 19 test kits registrations that are already on the market cannot be turned into self-test registrations;

– ANVISA has defined minimum sensitivity and specificity values which the tests must meet. The tests will have to undergo prior analysis in a Brazilian laboratory (National Institute for Quality Control in Health);

– BRH must have a call center for user support, with direct access to qualified personnel to meet, guide and forward the interested party’s demands on the use of the product, interpretation of results and on how to proceed after obtaining the results;

– Additional requirements for Instructions for Use are: clear instructions for lay user to collect and perform the test, using photos or illustrations to facilitate the test and subsequent interpretation; hygiene conditions in order to proceed with the test, information related to covid-19’s prevention;

– BRH may make registry systems of test results available in the form of the National Testing Expansion Plan for Covid-19.

ANVISA will prioritize the analysis of COVID-19 self-test kits’ registration petitions, while the COVID-19 public health emergency persists in Brazil. COVID-19 self-test kits aim to bring additional aid to the Brazilian population to better detect and monitor infections, although in terms of guidance, it will not be considered conclusive as a diagnosis. It is worth mentioning that self-tests do not replace the diagnosis performed by a healthcare professional.

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DOMO Salute team