Overview:
Brazil’s Anvisa approves resolution establishing requirements for registration, distribution, commercialization, and use of covid-19 self-tests.
Introduction
Brazil’s National Health Surveillance Agency (Anvisa) approved, on Friday (01/28), during its 3rd Extraordinary Public Meeting of 2022, the resolution that establishes the requirements and procedures for the application for registration, distribution, marketing and use of self-tests for detection of the Sars-CoV-2 antigen.
What will be allowed with this self-test approval?
- With the approval, it will be allowed the sale of self-tests directly to consumers by pharmacies and health establishments licensed to sell medical devices.
- The commerciliazation of self-tests on the internet on websites that do not belong to pharmacies or health establishments authorized and licensed by the competent health surveillance agencies is prohibited.
Do the devices need registration at Anvisa?
Attention! No self-test can be commercialized immediately in the country. Legally qualified companies that wish to sell these devices will have to register the product with Anvisa.
The Collegiate Directive Resolution (RDC) approved today establishes the criteria for the registration petition, as well as defines that petition related to the subject will be analyzed with priority by the Agency, while the declaration of public health emergency is maintained.
- Self-tests can only be commercialized in the country after registration of the product with Anvisa.
– Anvisa will analyze the self-test registration requests with priority. - The sale of self-tests on sites that do not belong to pharmacies or health establishments authorized and licensed by the sanitary surveillance organs is prohibited.
- The self-test does not define a diagnosis, which must be made by a health professional. Its character is orientative. In other words, it is not a medical certificate.
- The result of the self-test is not valid for travel and entrance in events.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.