Manual de regularização de um aparelho de ultrassom com finalidade de diagnóstico por imagem junto aos órgãos reguladores

Abstract

The coronavirus (COVID-19) pandemic caused by the SARS-COV-2 virus was enacted 32 months ago. During this period, Brazil has more than 35 million positive cases and has 82.4% of the population fully vaccinated. Knowing that one of the main symptoms of the disease affects the respiratory system, a study by the Hospital das Clinicas da Faculdade de Medicina de São Paulo (HCMUSP) based on a study conducted in Wuhan, China found that the ultrasound image exam of the lung can be a great ally in identifying lung problems caused by COVID-19. The Brazilian market for ultrasound imaging devices has been constantly growing over the last 13 years, and currently has more than 50,000 devices in use in Brazil. Brazilian legislation requires that any medical equipment sold in Brazil must be registered with the Ministério da Saúde, failing which the Company may be subject to sanctions. The Agência Nacional de Vigilância Sanitária, National Health Surveillance Agency, which are regulated by specific resolutions, currently for risk class I and II products, ANVISA resolutions RDC N° 40/2015, RDC N° 270/2019 and RDC N° 423/2020 are used. For higher risk class III or IV, ANVISA resolution RDC N°185/2001 is used. In addition to registration with ANVISA, for certain medical equipment such as ultrasound, it must have the certificate of conformity from the National Institute of Metrology (INMETRO), currently following INMETRO’s Ordinance N° 384 of 2020 and Ordinance N° 200 of 2021. For equipment that uses accessories with bluetooth or wi-fi, it is necessary to approve these with the National Telecommunications Agency (ANATEL) currently followed by Resolution N°715, of October 23, 2019. The commercialization of medical equipment can only occur after obtaining all necessary equipment certificates and licenses for the Company.