The National Health Surveillance Agency (Anvisa) received, on this Mondayon the 31st, the first self-test registration request for the detection of covid-19 in the country. The request was made by the Brazilian company Okay Technology Comércio do Brasil Ltda for an imported self-test, which uses swab nose to obtain the result.
Understand
THE resolution authorizing the use and commercialization of self-tests for the detection of covid-19 was published in the last fridayFriday (28) and regulated requirements and procedures for requesting registration and distribution of the product.
Anvisa informed that it has given priority to the analysis of requests involving this type of registration, so that they are approved in the shortest possible time.
In addition to aspects such as efficacy and safety, the self-tests will be evaluated, for example, regarding the regularity of the technical documentation, the accessibility of the instructions for use, the storage and disposal of the product for the lay user, in order to enable the use in a proper.
