The National Health Surveillance Agency (Anvisa) rejected requests for registration of three covid-19 self-tests. According to the agency, the requests were denied due to the lack of studies and complete documents on the products that requested authorization.
Companies have already been informed by means of an Electronic Letter about the necessary adjustment points for each product before a new submission can be made, informed Anvisa, in a note sent to Brazil Agency.
“These are the results of the first self-test registration requests evaluated by the Agency. Yesterday’s (Monday, February 7) publication by Official Diary of the Union brings three other self-tests that also had their requests denied. But in these cases, the denial happened because the requests were made before the validity of the rule that regulated self-tests for Covid19 in Brazil”, informed Anvisa.
The rejected records belong to the companies LMG Lasers; Medlevensohn; and Okay Technology. The two resolutions with the denials (nº 364 and nº 387) were published in the Official Diary of the Union yesterday (7).
Anvisa counts 33 registration requests for covid-19 self-tests – a number that does not consider requests made before the rule came into force.
Of these, three had denials already published in the Official Diary of the Union; four products had their analysis concluded and are awaiting the publication of the result; nine are under analysis by the technical area; and 17 were distributed to the area and are currently awaiting the start of the analysis.