Brazil (ANATEL) - Act 5701
The Agência Nacional de Telecomunicações (ANATEL) in Brazil has published Act 5701, which complements Act 4088 issued in 2020. Previously, Act 4088 confirmed that Telecommunication/RF devices subject to ANATEL approval must arrive in the country at customs properly labeled and identified with the ANATEL label/ID. Under the current wording from Act 4088, this requirement would be mandatory starting August 1, 2021. With the issuance of Act 5701, ANATEL increased the time for manufacturers to comply and this requirement will be mandatory starting August 1, 2022.
Medical devices that make use of wireless/RF technology, subject to both ANVISA registration and ANATEL approval, are also included in Act 5701’s mandatory requirement listed above.