In Brazil, medical devices must adhere to rigorous regulatory standards to ensure their safety, effectiveness, and quality. A key element of this regulatory framework is ANATEL certification. This blog delves into ANATEL certification, explaining its significance, legal foundation, and the certification process, while also providing practical tips for manufacturers aiming to understand and comply with this essential aspect of Brazilian medical device regulation.
What is ANATEL Certification of Medical Devices in Brazil ?
ANATEL, Brazil's National Telecommunications Agency (Agência Nacional de Telecomunicações), is responsible for regulating telecommunications and related technologies. ANATEL certification is mandatory for medical devices that incorporate wireless communication technologies, including Wi-Fi, Bluetooth, and other radio frequencies. It ensures that these devices comply with Brazil's standards for electromagnetic compatibility and radiofrequency emissions. Importantly, obtaining ANATEL certification is a prerequisite for applying for ANVISA registration.
Medical devices with wireless features—such as Bluetooth, Wi-Fi, and radio frequency—must obtain ANATEL certification and homologation before they can be legally marketed and used in Brazil, and before ANVISA registration can be pursued.
Understanding the Roles in Regulation of Medical Devices in Brazil: ANATEL Certification vs. ANVISA Registration
In Brazil, the regulation of medical devices involves several agencies, each with specific responsibilities:
ANATEL Certification: This agency focuses on the technical standards for devices with wireless or electronic components. It ensures that these devices meet Brazil’s requirements for electromagnetic compatibility and radiofrequency emissions. ANATEL regulates all telecommunications products in Brazil, akin to the Federal Communications Commission (FCC) in the U.S.
ANVISA Registration: Managed by the National Health Surveillance Agency (ANVISA), this process assesses the overall safety, efficacy, and quality of medical devices. ANVISA’s review includes evaluating clinical data and conducting thorough assessments for market approval.
While ANATEL certification deals with technical compliance, ANVISA registration addresses broader concerns related to safety and performance.
Legal Basis for ANATEL Certification in Brazil
ANATEL certification is governed by Brazilian telecommunications regulations, primarily set out in the General Telecommunications Law (Lei Geral de Telecomunicações) and related decrees. These regulations provide the framework for the technical standards, testing, and certification necessary for devices using wireless communication technologies. Key regulations include:
Resolution 715/2019: Specifies the certification requirements for telecommunications products.
Resolution No. 680/2017: Covers radiocommunication equipment with restricted radiation.
Act 423: Updates Act 14448 regarding technical requirements for assessing restricted radiation radiocommunication devices and includes new permitted devices in Brazil.
Act 237: Revokes Act 6506 and revises testing procedures for restricted radiation radiocommunication devices.
ANATEL certification is a vital component of the registration process, particularly for devices that facilitate remote patient monitoring or data transfer.
Who Issues ANATEL Certificates ?
ANATEL certificates can be issued directly by ANATEL or through certification bodies accredited by ANATEL. These accredited bodies evaluate and certify devices to ensure they meet technical standards for electromagnetic compatibility and radiofrequency emissions. Certification bodies must be listed on ANATEL’s official website and are responsible for assessing products and recommending accredited laboratories for testing.
What are Designated Certification Bodies (OCDs)?
Designated Certification Bodies (Organismo de Certificação Designado (OCDs)) are third-party organizations authorized by ANATEL to issue certifications. Only those OCDs listed on ANATEL’s official website are permitted to provide certification. These bodies evaluate products and issue certificates based on tests conducted by laboratories accredited by Inmetro. The OCDs also recommend appropriate laboratories for testing based on the product’s technical specifications.
Which Medical Devices Require ANATEL Certification?
ANATEL certification is not necessary for every medical device—only those equipped with wireless communication features or electronic systems susceptible to radio frequencies. Devices lacking these features may not need ANATEL certification but must still comply with other regulatory standards. This includes devices with built-in wireless capabilities such as remote monitoring systems, diagnostic equipment with wireless functions, and other electronic medical devices. This certification applies to both the primary device and any electronic components or accessories. Specifically, ANATEL certification is mandatory for products that:
Transmit data or voice via radio frequency or cables.
Feature telecommunications functionalities such as Bluetooth, wireless connectivity, Wi-Fi, or interfaces with cell phones.
Categories of Telecommunication Products Classified by ANATEL
ANATEL classifies telecommunication products into three categories: Category I, II, and III.
Category I:
Includes low-risk, less technically complex telecommunications products.
These typically involve devices that do not have advanced technologies or features that could significantly interfere with telecommunications networks.
Examples : mobile phones, satellite phones, and VOIP phones.
Products in Category I require annual laboratory testing and re-evaluation.
If a manufacturer does not hold ISO 9000 certification, ANATEL will assess the manufacturing process through plant inspections.
Certification involves testing at an INMETRO-accredited laboratory, followed by annual re-evaluations.
Category II:
This category encompasses telecommunications products with moderate complexity and risk.
These devices may have advanced functionalities and could potentially cause some network interference.
Examples : Wi-Fi equipment and RF automation devices such as wireless cardiac monitors, implanted cardiac pacemakers, defibrillators, neuromuscular stimulators, RFID wireless systems, and Handheld TENS devices
They require initial laboratory testing and bi-annual document verification, with no additional lab testing required for re-evaluation.
Category III:
Products in this category are highly complex and pose a greater risk.
They include sophisticated equipment that may significantly impact networks and require stringent technical analysis.
Examples include optical fiber cables and mobile network signal transmitters.
Category III products require initial laboratory testing but do not need periodic re-evaluation.
Devices must comply with specific certification and testing requirements based on their category.
Types of ANATEL Certificates
ANATEL issues various types of certificates based on product categories:
Declaration of Conformity: Issued for non-commercial handcrafted products.
Declaration of Conformity with Analysis Report: Used when an application cannot be evaluated by an OCD within 3 months, necessitating evaluation by ANATEL itself.
Certification of Conformity with System Quality Evaluation: Applicable to Category I products.
Certification of Conformity Based on Type Analysis and Periodic Evaluation: For Category II products.
Certification of Conformity Based on Type Analysis: For Category III products.
Who Can Apply for ANATEL Certification?
Applications for ANATEL certification can be submitted by:
Domestic Manufacturers: Either directly or through their representatives in Brazil.
Suppliers and Importers: Operating within Brazil.
Foreign manufacturers must apply through their Brazilian distributor or legal representative, who must be registered in Brazil
Documentation Requirements for ANATEL Certification
Applying for ANATEL certification involves a comprehensive documentation process to ensure that your product meets all technical and regulatory standards. Here is a list of the essential documents you need to submit:
Applicant and Manufacturer Information: Provide detailed contact information for both the applicant and the manufacturer. This should include company names, addresses, and contact details.
Manufacturing Plant Details: Submit information about the manufacturing facility where the product is produced. This includes the plant's address and any relevant operational details.
User and Product Manuals: Include comprehensive user and product manuals that outline the usage, installation, and maintenance of the device. These manuals help verify that the product complies with regulatory requirements.
Technical Specifications: Provide a detailed technical description of the product, including its functionality, design, and performance characteristics.