Conformity certificates are issued by accredited organisms and attest the compliance of products, processes or systems with specific standards. They prove quality, safety and performance following applicable regulations. Among the different types of certificates of conformity, ANATEL certification is also widely used in health products.
ANATEL is the regulatory agency responsible for supervising and controlling the telecommunications sector in the country, and its certification guarantees that devices meet the quality and safety standards established by Brazilian technical standards. The certification process aims to guarantee that these products do not interfere or harm the operation of other devices and telecommunications networks, as well as that they are safe for consumers to use.
The Regulation for Conformity Assessment and Homologation of Telecommunications Products, approved by RDC No. 715 of October 23, 2019, establishes that the issuance of the homologation document is a mandatory prerequisite for the marketing and use of telecommunications products in Brazil.
In addition, with regard to health products, the ANATEL certificate is compulsory for products that contain specificities, including:
- Products that transmit data or/and voice by radio frequency or cables;
- Products that contain telecommunications functionalities such as: bluetooth system, wireless connection, Wi-Fi and interface with the cell phone;
The products are classified into 3 categories (1, 2 and 3) and the Designated Certification Bodies (OCD) are responsible for evaluating the product and classifying it according to the classifications already defined by the agency. Only organizations listed on ANATEL’s official website can issue such certification – they can be accessed at this link.
- Category 1: These are low-risk and less technically complex telecommunications products. Generally, they include devices and equipment that do not have advanced technologies or characteristics that could significantly interfere with telecommunications networks.
- Category 2: In this category are telecommunications products with a moderate level of complexity and risk. It encompasses devices that may have more advanced functionality and may present some risk of interference in networks.
- Category 3: Highly complex and risky telecommunications products are classified in Category 3. These devices may include more sophisticated and technologically advanced equipment that may have a significant impact on networks and require more rigorous technical analysis.
Medical products that fit into the above categories must present an approval certificate from Anatel (National Telecommunications Agency) or a test and test report that proves the safety of these devices, ensuring that the radiofrequency and electromagnetic field emissions are within the limits established by regulation.
Anvisa even warns that manufacturers and importers follow the duty to comply with all obligations determined by Anatel, such as Resolution No. 680, of June 27, 2017, which approves the Regulation on Radiocommunication Equipment with Restricted Radiation.
