Case Study 71: Registration of Covid-19 Test Kit in Brazil

Company Situation

Client is a European medical device company that develops and manufactures Antigen Test Kits , was looking for a regulatory professional in Brazil that can act as its local representative in Brazil and register with Anvisa an Antigen rapid test kit used for SARS-CoV-2 Antibody testing.
The Covid-19 test kit is intended for the qualitative detection of antibody content against SARS-CoV-2 in clinical samples (serum/plasma/whole blood). The product has a CE mark and sold in Europe.

GRP Solution

Global Regulatory Partners Brazil (GRP Brazil) has a team of regulatory experts in Brazil who has registered successfully many medical devices and IVDs with Anvisa. After receiving the technical information from the client, the team was able to:

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