ANATEL (National Telecommunications Agency)

The National Telecommunications Agency, known as ANATEL (Agência Nacional de Telecomunicações), is Brazil’s federal telecommunications regulator. Established under Law 9.472/1997, it manages radio spectrum, sets technical requirements, and certifies and homologates telecommunications products.

ANATEL is not Brazil's general medical device regulator. That role belongs to ANVISA. ANATEL becomes relevant when a medical device incorporates regulated telecommunications or radio-frequency functionality.

Which medical devices need ANATEL approval?

Medical devices with Bluetooth, Wi-Fi, cellular, or other radio transmitters may require ANATEL certification and homologation before they can be commercialized or used in Brazil. Applicability depends on the radio technology, frequency, power, module approval, integration, and current ANATEL technical requirements.

Using a previously approved wireless module can simplify some evidence, but it does not automatically prove that the complete medical device is exempt. The finished configuration, antennas, labeling, and integration should be assessed.

How does ANATEL approval relate to ANVISA registration?

ANATEL approval addresses telecommunications and radio requirements; ANVISA market authorization addresses medical device safety, performance, quality, and regulatory compliance. A connected medical device may need both approvals. Projects should evaluate ANATEL, INMETRO, cybersecurity, and ANVISA requirements early because the workstreams can affect testing and submission timing.

The certification process typically involves an ANATEL-designated certification body, applicable laboratory testing, issuance of a conformity certificate, and ANATEL homologation. Requirements may change, so confirm the current route through the official ANATEL portal.

Is ANATEL the medical device regulator in Brazil?

No. ANATEL regulates telecommunications and radio-frequency functions, while ANVISA regulates medical device safety, performance and market authorization. A connected device may require both processes. Manufacturers should coordinate the technical configurations used for ANATEL testing with the model and labeling submitted for Brazil registration.