Our Services

ANATEL Homologation

Telecom & Wireless Products

We ensure that your telecommunications products comply with all technical and regulatory requirements set by ANATEL. From the initial steps to final certification, we manage the entire process, ensuring your products are fully prepared for safe commercialization in the Brazilian market, while adhering to all current legislation.

How ANATEL Approval Works

How ANATEL Approval Works

ANATEL (Brazilian National Telecommunications Agency) certification is a mandatory process for all telecommunications products that will be sold and used in Brazil. This process ensures that devices comply with the technical and regulatory standards required by the Brazilian government, guaranteeing the safety, quality, and compatibility of these products in the national market.

Main Steps of ANATEL Certification:

  1. Product Classification
    The first step is to identify the product category, as ANATEL classifies devices into different types, such as mobile phones, data terminal stations, transceivers, data network equipment, modems, cell phone chargers and batteries, among others.

  2. Choosing a Designated Certification Body (OCD)
    An OCD designated by ANATEL is responsible for conducting the technical evaluation of the product. The OCD issues a certificate of conformity after performing all the necessary tests based on applicable standards.

  3. Laboratory Testing
    The products undergo a series of tests in laboratories accredited by INMETRO and/or evaluated by ANATEL. These tests assess compliance with technical requirements, such as electrical safety, electromagnetic compatibility (EMC), functional performance, radiofrequency performance, among others.

  4. Issuance of the Certificate of Conformity (CoC)
    Once the product passes the tests and all the documentation is prepared, the OCD issues the certificate of conformity, which is required for the next step in the certification process.

  5. Homologation by ANATEL
    The certificate of conformity, along with all the product documentation, is submitted to ANATEL. The agency reviews the documents and, once approved, issues the official homologation of the product.

  6. Commercialization in the Brazilian Market
    With ANATEL certification in hand, your product is legally authorized to be sold and used in Brazil. Certification ensures that the product meets all necessary technical and safety requirements.

Why is Homologation Important?

ANATEL homologation is essential to ensure that telecommunications products operate efficiently and safely, without causing interference with other devices and networks. Additionally, it is a mandatory legal requirement for the commercialization of these products in Brazil, protecting both consumers and manufacturers from potential safety and quality issues.

INMETRO Certification

Medical Products, Home Appliances, IT Equipment

We offer comprehensive support in the INMETRO certification process to ensure that your medical products, home appliances, and IT equipment meet the quality and safety standards required by the Brazilian market. From technical analysis to obtaining the compliance seal, our team oversees every step to ensure your products are regulated and can be safely marketed.

How INMETRO Certification Works

INMETRO (National Institute of Metrology, Quality, and Technology) certification is a mandatory process to ensure that products sold in Brazil meet the quality, safety, and efficiency standards established by the Brazilian government. For electromedical products, household appliances, and IT goods, this certification is essential to ensure that the devices operate safely and efficiently, minimizing risks to the health and integrity of users.

INMETRO has two types of certification: Compulsory and Voluntary. 

In both cases, an INMETRO ordinance defines the mandatory requirements that must be followed by all companies producing a specific product, as well as the deadlines for the company to comply with the regulation. The first step is to determine if there is a certification applicable to your product and if the certification is compulsory or voluntary. The list of products covered by INMETRO’s Conformity Assessment Program can be found on the institute’s website at the following links:

Main Steps of INMETRO Certification:

  1. Determine the applicable certification program and INMETRO Ordinance for the productElectromedical products, household appliances, and IT goods have specific regulations that aim to ensure electrical safety, functional performance, and electromagnetic compatibility.

  2. Choosing an Accredited Certification Body (OCP)
    The next step is to choose a Product Certification Body (OCP) accredited by INMETRO. The OCP is responsible for conducting the entire certification process, including the evaluation of compliance tests performed in accredited laboratories.

  3. Laboratory Testing
    The products undergo a series of laboratory tests to ensure they comply with the technical safety and performance requirements. These tests vary according to the type of product:

    • Electromedical Products: Rigorous tests for electrical safety, electromagnetic compatibility, and performance are conducted to ensure that medical equipment is safe for patients and operators.
    • Household Appliances: Tested for energy efficiency, electrical safety, durability, and resistance, ensuring that they are safe for domestic use.
    • IT Goods: Evaluated for electromagnetic compatibility and electrical safety to ensure the product meets quality standards and does not cause interference with other electronic devices.

INMETRO accepts test reports conducted abroad by laboratories accredited by ILAC (International Laboratory Accreditation Cooperation) members and the IECEE CB SCHEME (Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components), depending on the type of product. This acceptance allows manufacturers and importers to expedite the certification process in Brazil, as long as the reports comply with Brazilian technical requirements and standards.

  1. Conformity Assessment and Factory Audit
    To ensure that products continuously meet quality standards, the INMETRO certification process includes a factory audit. This audit verifies whether the production processes comply with established standards and whether large-scale production maintains the same quality standards as the tested products.

  2. Issuance of the Certificate of Conformity
    Once the products pass laboratory tests and the factory is approved in the audit, the OCP issues the Certificate of Conformity, proving that the product meets all the technical and safety requirements established by INMETRO.

  3. INMETRO Conformity Seal
    After certification, the product can receive the INMETRO seal, which must be present on its packaging or the product itself. This seal assures consumers that the item has undergone rigorous quality and safety testing and is fit for sale in Brazil.

Why is INMETRO Certification Important?

INMETRO certification is essential to protect consumers and ensure that electromedical products, household appliances, and IT goods are safe and efficient. Moreover, it is a legal requirement for the commercialization of these products in Brazil, ensuring they comply with international quality and safety standards. This provides manufacturers with greater credibility in the market and gives consumers the confidence that they are purchasing products that meet all safety regulations.

IBAMA Registration

Noise Seal

The IBAMA Noise Label is a mandatory certification in Brazil for certain types of home appliances that emit noise, with the purpose of informing consumers about the noise level produced by the device. Created in accordance with the National Program for Education and Control of Noise Pollution, the label is regulated by the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA).

What is the purpose of the IBAMA Noise Label?

The Noise Label serves two main purposes:

    1. Protecting consumer health and well-being: The label provides clear and accessible information about the noise level generated by the equipment, allowing consumers to choose products that emit less noise, promoting more acoustic comfort and reducing noise pollution.
    2. Encouraging the production of quieter products: By requiring the measurement and disclosure of noise levels, the label encourages manufacturers to develop technologies and products that operate more quietly, reducing the environmental and social impacts of noise pollution.


How does the IBAMA Noise Label work?
The process of obtaining the label involves the following steps:

    1. Noise level measurement:The manufacturer or importer must submit the product for noise measurement tests in laboratories accredited by INMETRO. The measurement is done in decibels (dB) and follows the technical criteria of the NBR 13910 standard, which defines the exact test conditions.
    2. Classification: Based on the measurement results, the product is classified on a scale from 1 (quietest) to 5 (noisiest). Therefore, the lower the number, the better. To receive the best rating, a hair dryer cannot exceed 78 decibels, a vacuum cleaner 80 decibels, and a blender 85 decibels.
    3. Labeling the product: After measurement and approval, the label is affixed to the product or its packaging, indicating the measured noise level. Consumers can view this information before purchasing the equipment.

Which products require the Noise Label?
The Noise Label is mandatory for a variety of home appliances, especially those that traditionally generate higher levels of noise during use. Examples of products that need this label include:

  • Vacuum cleaners;
  • Hair dryers;
  • Blenders.

 

Importance of the Noise Label
The IBAMA Noise Label is an important tool for both environmental protection and improving consumers’ quality of life. It raises awareness about noise pollution and promotes more sustainable and comfortable choices in everyday life.



ANVISA Registration

Medical Products

The registration of medical products with ANVISA (Brazilian Health Regulatory Agency) is a mandatory process for the commercialization and use of these products in Brazil. ANVISA regulates the entry of medical devices and ensures that these products meet the necessary requirements for quality, safety, and efficacy, protecting public health

How ANVISA registration works and its purpose

  1. Product Classification

    Medical products are classified into four risk classes by ANVISA, depending on their potential to cause harm:
  • Class I: Low risk (e.g., simple bandages).
  • Class II: Medium risk (e.g., ultrasound equipment).
  • Class III: High risk (e.g., prosthetics).
  • Class IV: Very high risk (e.g., defibrillators)

    The higher the risk, the more rigorous the registration process.

  1. Registration Process

    The process involves submitting a series of technical and administrative documents, which vary according to the product’s risk class. The main steps include:

  • Registration or Notification: Products in Classes I and II typically require “Notification,” which is a simplified process. Products in Classes III and IV require full “Registration,” a more detailed and rigorous process.
  • Technical Documentation: The manufacturer must provide technical information about the product, including specifications, clinical studies (if applicable), and data on safety and efficacy.
  • Good Manufacturing Practices (GMP): The manufacturing company must have a GMP certificate, ensuring that the factory follows proper manufacturing standards.
  • Conformity Assessment: In some cases, the product must undergo laboratory testing or additional certifications, especially for higher-risk products.
  1. Purpose and Importance

    The main goal of medical product registration with ANVISA is to ensure that they are safe and effective for use in the healthcare system and by end consumers. By requiring compliance with technical standards and risk assessment, ANVISA protects public health from low-quality products or technical failures that could harm patients. ANVISA also ensures that imported or locally manufactured medical products comply with international standards, promoting competitiveness in the national market and building consumer trust in the available products.

    This regulation is essential for ensuring that doctors, hospitals, and the general public have access to reliable and high-quality products.

Samples Configuration

Our engineering team, with over 10 years of experience, provides comprehensive support in configuring samples for certification testing. With state-of-the-art equipment, such as Spectrum Analyzers for WLAN and CMU200 & CMW500 for WWAN, we ensure that your products are properly configured to meet technical and regulatory requirements. The entire process is carried out in our office, ensuring accuracy, efficiency, and reliability in test results.

Samples Configuration

Currently, national laboratories are facing a high volume of projects, which compromises their ability to meet demand quickly and with the necessary lead time to configure and verify products. This situation significantly increases the risk of test delays, as if the laboratory is unable to configure the product before the scheduled date, the test may be postponed or even canceled, potentially delaying the project’s timeline by several months.

To mitigate these risks, E3Tech has developed a dedicated structure equipped with high-tech instruments and a team of qualified engineers. This team is responsible for verifying test samples and ensuring they are 100% operational, minimizing the chances of delays and ensuring greater efficiency in the certification process.

Technical Translation

Manuals, Certificates, and Other Documents

We offer professional technical translation services, including certified translations, for manuals, ISO certificates, and other critical documents. Our team of specialized translators guarantees precision and clarity in adapting content into Portuguese (for Brazil) and Spanish (Latin America), ensuring that all specifications and standards are accurately conveyed. This helps to facilitate compliance with regulatory requirements while ensuring the content is easily understood by end users.

Learn with us how you can get Certified

Welcome to our informative blog! As a Brazilian leading company in product certification, we specialize in helping foreign companies navigate the complex regulatory environment in Brazil.

With over 20 years of experience, our expertise ensures a smooth process for achieving certification in this dynamic market. Whether you’re looking to understand how to get certified in Brazil or the latest updates on product certification in Brazil, this blog is your go-to resource.

On our blog we are dedicated to providing clear, actionable insights to help you succeed in bringing your products to the Brazilian market with confidence.

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