Brazil ANATEL Certification Compliance

Start Your Brazilian Market Entry Success with Freyr's Expertise!

The National Telecommunications Agency, or ANATEL (Agência Nacional de Telecomunicações), oversees the regulations of all telecommunication devices marketed in Brazil.

Start Your Brazilian Market Entry Success with Freyr's Expertise! Overview

The National Telecommunications Agency, or ANATEL (Agência Nacional de Telecomunicações), oversees the regulations of all telecommunication devices marketed in Brazil. Before being registered with ANVISA, medical devices, which utilize Bluetooth, Wi-Fi, Radio Frequency (RF), and other wireless interfaces must undergo ANATEL certification and homologation, a process known as Brazil ANATEL Certification.

It is strictly forbidden to use or sell telecommunication devices in Brazil without ANATEL approval. Approval codes are non-transferable and unique to each holder; approved products must display the ANATEL logo and their unique approval number.

The Mosaico system, introduced by the Agência Nacional de Telecomunicações (ANATEL) in Brazil, is the new online platform for monitoring the certification process of telecom equipment, replacing the former Sistema de Gestão de Certificação de Homologação (SGCH) system. Registration in Mosaico is essential for producers, importers, and certifying bodies to access ANATEL approval certificates, track homologation requests, and submit applications for telecommunication devices.

For a foreign manufacturer, the application for approval must be made by the distributor or the legal representative of the company in Brazil. This representative must be registered in the country and be responsible for the legal aspects of the product's sale.

Let us help you navigate ANATEL certification and bring your innovative medical device to the Brazilian market. Freyr has an in-house office in Brazil with medical device Regulatory experts to streamline the approval process. For expert assistance, contact Freyr's specialists.

Freyr Brazil ANATEL Certification Competencies:

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    Consultation on ANATEL compliance to understand specific requirements for wireless medical device certification.
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    Support the application process via the Mosaico system.
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    Provide technical support by developing test plans, liaising with test labs, and preparing technical documentation.
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    Robust Quality Management Systems (QMSs) implementation and gap assessment.
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    Maintaining and updating certification (as required).
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    Audit and inspection preparedness.
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    Post-certification support after ANATEL approval.

Frequently Asked Questions (FAQs)

  • Devices that use Bluetooth for communication or data transfer.
  • Devices that incorporate Wi-Fi for transmitting data or for the purpose of remote monitoring.
  • Any Radio Frequency (RF) utilizing technology for sending or receiving signals, among various functionalities.

  • Streamlined Process: Medical device Regulatory expertise saves you time and resources.
  • Reduced Risk of Errors: Knowledge of the Regulatory experts increases the likelihood of first-time approval.
  • Faster Market Entry: Consultation on ANATEL compliance expedites your path to certification.

  • The processing time for acquiring ANATEL certification for your wireless medical device can vary depending on several factors, such as device complexity, completeness of the application, and ANATEL workload.
  • It takes a total of three (03) months to acquire the ANATEL certification.
Book a meeting with our Brazil ANATEL experts

Medical Device Regulatory Consulting – Proven Expertise

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Countries
1900

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Global Customers
2200

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In-house Regulatory Experts
850

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In-country Regulatory Affiliates
8
Global Delivery Hubs
 

Why Freyr?

  • Independent Representation and Regulatory Support in Brazil.
  • Continuous Liaison with ANATEL via the Mosaico System for Submissions, Queries, and Feedback.
  • Single Point of Contact (POC) in Brazil for ANATEL certifications for all telecommunication devices.