National Telecommunications Agency (ANATEL)

What is ANATEL? The National Telecommunications Agency, known as ANATEL (Agência Nacional de Telecomunicações), is Brazil’s federal authority responsible for regulating and supervising the country’s telecommunications sector. It ensures that any wireless or radio-enabled device meets Brazil’s technical standards for telecom functionality, including medical devices that transmit data. It was established in 1997 under the General Telecommunications Law (Law 9.472) and became the first independent regulatory agency in Brazil. ANATEL has administrative and financial autonomy, and its decisions may only be contested in court. What does ANATEL do? ANATEL regulates technical standards, issues licenses, and manages the use of radio frequency spectrum. It enforces certification requirements for telecommunications equipment, which must undergo in-country testing and approval before being imported or marketed in Brazil. The agency also monitors market practices to promote competition, supports infrastructure expansion, and manages spectrum auctions that drive investment and innovation. What is ANATEL's role in medical devices regulation in Brazil? Medical devices that incorporate Bluetooth, Wi‑Fi, cellular, or other telecom modules must obtain ANATEL certification to demonstrate conformity with electromagnetic compatibility and radiofrequency emission standards before ANVISA will grant market authorization. ANATEL certification is obtained through testing conducted by laboratories accredited by ANATEL.