Regulation, Licensing, and Accreditation of the ART Laboratory in Brazil

According to the International Federation of Fertility Societies (IFFS) latest surveillance report, there are approximately 5353 ART centers around the globe. Only 57.1% of the countries have to follow specific legislation regulating ART activities, while 24.3% have only national society guidelines without any formal legislation, and 18.6% have no regulatory structure in the form of legislation or guidelines. In Brazil, the regulatory agency (ANVISA) issued a regulation for reproductive cells and tissues banks, which includes assisted reproductive technology (ART) centers, in 2006. The regulation was later reviewed, in 2011, to include more details and explanations not very clear in the first resolution, and was again reviewed in 2016 to include specific testing instructions due to the Zika virus outbreak and microcephaly cases. Besides the regulatory agency regulation, ART centers must observe ethical standards established by the Medical Council (CFM 2121/2015), a professional organization that doctors and clinics must comply with, and whose objective is to guarantee the safety and efficacy of medical procedures and treatments involved in ART.