Anvisa (National Health Surveillance Agency) rejected three requests for self-tests in Brazil. So far, 51 requests have been made for the release of the product, but none have been approved.
The regulatory agency has approved the sale of self-tests in Brazil as a form of screening for Covid-19. However, each company will need to apply for registration with Anvisa to market the product.
The rejected requests were from the companies LMG Lasers, Medlevensohn Comércio e Representações de Produtos Hospitalares and Okay Technology Comércio do Brasil.
“The requests were denied due to the lack of studies and complete documents on the products that requested authorization. The companies have already been informed through an electronic letter about the necessary adjustment points for each product before a new submission can be made”, said in note.
In addition to the rejected requests, six have their analysis completed and are awaiting publication in the Official Gazette of the Union. However, the regulatory agency did not say whether they will be approved.
Four are under analysis by the technical area, and six are under technical requirement, that is, there is a need for the presentation of complementary data by the manufacturer. The rest are still waiting for the start of the analyses.
The regulatory agency said that another three requests were denied because they were delivered before Anvisa’s resolution that regulates this type of exam. The publication took place on Monday (7) in the Official Gazette of the Union.
The self-test will serve to expand the testing of symptomatic and asymptomatic individuals and their possible contacts. In this way, early isolation and breaking the chain of transmission could occur.
According to Anvisa’s decision, the self-test can only be marketed in pharmacies with and without manipulation and licensed health establishments. These licensed establishments will also be able to sell online.
Such as leaf showed, the sector is already preparing to serve the market. The executive president of CBDL (Brazilian Chamber of Laboratory Diagnosis), Carlos Gouvêa, estimated that the industry installed in Brazil has the capacity to produce up to 10 million Covid self-tests per month.
He also said that self-tests should be cheaper than antigen tests sold in the pharmacy.
As informed in the technical note from the Ministry of Health, the self-test will become a new screening tool for the PNE (National Testing Expansion Plan for Covid-19).
Thus, the person with a positive result should seek a health care unit or telecare so that a health professional can confirm the diagnosis, notify and provide relevant guidelines for surveillance and health care.
Chad-98Weaver, a distinguished author at NewsBulletin247, excels in the craft of article writing. With a keen eye for detail and a penchant for storytelling, Chad delivers informative and engaging content that resonates with readers across various subjects. His contributions are a testament to his dedication and expertise in the field of journalism.
