The authorization aims to ensure that the material imported for assisted human reproduction has quality and safety.
Anvisa (National Health Surveillance Agency) makes available on its query system the list of Brazilian companies authorized to import gametes (eggs or semen) and human embryos from foreign banks. For a period of 2 years, these companies may carry out the activities of importing, transporting, storing and distributing biological material for carrying out assisted human reproduction procedures.
The authorization informs that the company complies with the requirements set out in the Good Practices standard (RDC 771/2022 – find out more about the resolution below), guaranteeing the safety and quality of these imported materials.
This process also ensures that supplier banks meet criteria that include carrying out clinical and laboratory tests, process validation, quality control, among other relevant aspects.
There are two processes for importing human gametes and embryos in force. Either the import of samples from the patient himself or the import of samples from donors via importer authorization. Read which companies have been authorized by Anvisa:
- CrioBrasil Services
- Close Services
- WE Bank Brazil
- LAB Male Medicine
Gametes and embryos
The importer qualification process was established by RDC 771/2022, which provides for Good Practices in Germ Cells, Germ Tissues and Human Embryos, for therapeutic use.
Good practices consider “minimum technical and sanitary requirements related to the production cycle of human germ cells and tissues and embryos, with a view to the safety and quality of these products”.
According to Anvisa, assisted human reproduction techniques can be performed with gametes and embryos donated and processed in Brazilian centers and through the use of biological material from foreign donors.
“With the global increase in imports of gametes and embryos, it becomes crucial to establish specific requirements to ensure the safety and quality of these imported materials.”
According to the agency, in addition to assessing the quality of samples, importing companies must ensure compliance with documentation, foreign and local regulations, as well as standardized procedures.
“All imported batches must be reviewed and certified for quality before being released to Brazilian clinics. Furthermore, importing companies are responsible for implementing pregnancy control mechanisms, in order to comply with the provisions of the Federal Council of Medicine (CFM) resolution.”
With information from Brazil Agency and of the Gov.br.
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