Anvisa regulates the use of self-tests for Covid-19 — Portuguese (Brazil)

The Collegiate Board of Anvisa approved, this Friday (28/1), during its 3rd Extraordinary Public Meeting of 2022, the resolution which establishes the requirements and procedures for requesting registration, distribution, marketing and use of self-tests for the detection of the Sars-CoV-2 antigen.

Access the Frequently Asked Questions on the topic here.

With the approval, the sale of self-tests directly to the consumer by pharmacies and health establishments licensed to sell medical devices will be allowed. It is important to make it clear that the offer of self-tests on the internet on electronic sites that do not belong to pharmacies or health establishments authorized and licensed by the competent health surveillance bodies is prohibited.

Heads up! No self-test can be immediately marketed in the country. Legally qualified companies that wish to put these devices for sale will have to register the product with Anvisa. The Resolution of the Collegiate Board of Directors (RDC) approved today establishes the criteria for requesting the registration, as well as, in its article 22, defines that petitions related to the topic will be analyzed with priority by the Agency, as long as the declaration of health emergency is maintained. public.

Conditions

Among the requirements, Anvisa determines that the instructions for use, storage and disposal of the product are clear and that they use illustrations to facilitate the handling and interpretation of the result by the lay public, that is, by individuals without formal technical or scientific training. for product use.

The self-test registration applicant must have a user service channel, with direct access to qualified personnel to meet, guide and forward demands on the use of the product and how to proceed after obtaining the result. In addition to providing the contact for this service, the company must indicate the Dial Health Service of the Ministry of Health, in accordance with the National Plan for Expansion of Testing for Covid-19, the PNE-Teste.

Regarding the packaging, the external label of the product must contain all the components of the kit, which are necessary for the performance of the test, and also the validity of the device, in order to avoid its use after the expiration date.

monitoring

The self-tests are subject to post-marketing monitoring through the Health Surveillance Notification and Investigation System, Vigipós. The registration holder must be responsible for all post-marketing surveillance actions of the product, throughout its life cycle. This includes establishing mechanisms to monitor and notify technical complaints and adverse events, recall the product when determined by Anvisa or whenever there are sufficient indications that the device does not meet quality, safety and performance requirements, and also notification of field actions. resulting from adverse events associated with the product.

The retail sector, in turn, must notify adverse events and technical complaints in the Health Surveillance Notification System, Notivisa. In case the user notifies problems related to the use of the product directly to Anvisa, the person responsible for the registration must evaluate and respond to the demand in the computerized system made available by the Agency.

Historic

At a meeting held on January 19, 2022, Anvisa’s Collegiate Board of Directors, when evaluating the proposed regulation of self-tests, expressed the need for steps to clarify the constraints of public policy for the use of these devices by lay people.

According to the understanding of the Federal Prosecutor’s Office with Anvisa, the technical note previously sent by the Ministry of Health to the Agency did not fulfill the items considered necessary for a public policy. For this reason, a request for clarification with additional information was requested from the respective Ministry.

Check the summary

• Self-tests can only be marketed in the country after the product has been registered with Anvisa.
• Anvisa will review requests for registration of self-tests with priority.
• It is prohibited to sell self-tests on sites that do not belong to pharmacies or health establishments authorized and licensed by health surveillance agencies.
• The self-test does not define a diagnosis, which must be performed by a healthcare professional. Its character is orienting. That is, it is not a medical certificate.
• Self-test result is not valid for travel and event tickets.

Access RDC 595/2022

Access the Frequently Asked Questions on the topic.

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