January 28, 2022
Brazilian medical device and in vitro diagnostic (IVD) market regulator ANVISA has approved new rules that will facilitate the registration, distribution and sale of self-tests for detection of the coronavirus (SARS-CoV-2) antigen to consumers.
ANVISA's new regulation (link in Portuguese) will allow pharmacies and other healthcare retailers to sell COVID-19 self-test kits directly to the population as the COVID-19 public health emergency persists in Brazil. However, ANVISA notes that online sales of self-tests may be performed only by entities that have obtained required authorization and licensing from regulators.
Brazilian Registration Holders (BRH) seeking to import, market or distribute a COVID-19 rapid antigen self-test must first register that device with ANVISA; registration applications for these devices will receive expedited reviews by the regulator, according to ANVISA directors.
Furthermore, the new regulation will only apply to COVID-19 self-kits that involve samples from saliva or non-deep nasal swabs. Tests that require nasopharyngeal or oropharyngeal samples will not be available for direct sale to consumers in Brazil due to safety concerns.
Key components of ANVISA rules for COVID-19 self-test registration
ANVISA directors have disclosed high-level requirements planned for self-test registration:
- Clear instructions for use as well as storage and disposal of test kits that are easily interpreted and understood by lay users;
- Call centers set up by BRHs that provide access to qualified personnel to provide support to consumers using self-test kits as well as guidance on what to do once test results have been obtained; and:
- External labeling that includes all components of the self-test kit that are necessary to perform the test, as well as clear display of the test expiration date.
Furthermore, COVID-19 self-test device registrants must meet all requirements of RDC 36/2015, which encompasses Brazilian Good Manufacturing Practice (BGMP) certification, clinical evaluation and performance studies covering usability and stability. Requirements for in-country testing for sensibility and specificity also apply, which means that manufacturers will have to send their devices to the Instituto Nacional de Controle de Qualidade em Saúde (INCQS) for such testing before ANVISA will approve or reject their registration applications.
ANVISA’s move to prioritize registration and commercialization of coronavirus self-test kits provides an additional tool for Brazilian officials and healthcare providers to address the persistent and evolving coronavirus pandemic. Although only healthcare professionals may provide actual COVID-19 diagnoses, self-tests will help the Brazilian population to better monitor and detect possible infections.
Additional registration information regarding classification and required application documents will be available once ANVISA issues formal regulations for SARS-CoV-2 self-test kits.
Additional Brazil ANVISA medical device and IVD regulatory resources from Emergo by UL:
- Brazil Registration Holder (BRH) in-country representation
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