ANATEL Approval: compliant connectivity for your device.
Medical devices with wireless connectivity (Wi-Fi, Bluetooth, RF) need ANATEL approval to be marketed in Brazil. We manage the regulatory assessment, telecommunications testing and certificate management alongside INMETRO and ANVISA registration.
We manage the telecommunications requirements for your connected product's market authorisation.
Assessment of the product against ANATEL categories and requirements.
Determining applicable radiofrequency/telecommunications tests.
Liaison with designated laboratories and designated certification bodies (OCDs).
Document preparation and submission of the approval application.
Coordination with INMETRO and ANVISA for the complete product.
What you receive
Reference standards
- ANATEL regulations and acts for radiocommunications equipment.
- Applicable electromagnetic compatibility requirements.
- Integration with INMETRO certification and ANVISA registration.
Frequently asked questions
Does your device have wireless connectivity?
We manage ANATEL approval alongside INMETRO and ANVISA.
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