Approval of Wireless Health Equipment in Brazil

The use of technologies such as Bluetooth, Wi-Fi or other wireless communications, have for long spread across all fields and industries.

These types of technologies were not widely adopted in medical applications for many years, perhaps due to a certain level of hesitancy regarding its reliability and safety. However, it is undeniable that the adoption of wireless communication played an essential role in the development of products that have truly changed the monitoring, diagnostics and treatment of patients.

Brazil has two main governmental agencies involved in the approval of medical and health equipment which make use of any type of network connectivity or wireless communication: Anvisa and Anatel. Anvisa, the Brazilian Health Surveillance Agency, ensures that all medical and health-related products are safe and efficient towards humans.

In order to mitigate any telecommunication issues that may arise due to interferences and failure to comply with technology and safety standards, products or equipment with wireless communication capabilities are also required to be homologated by Anatel, the Brazilian Telecommunications Agency.

Requirements for medical products with wireless communications in Brazil

Regardless of the telecommunication capabilities of the product, Anvisa’s registration must be obtained by the manufacturer or importer prior to the equipment commercialization in Brazil. The process differs according to the invasiveness of the product for humans. We have written an extensive article about Brazilian regulation for health technology that can be accessed here: “Brazilian Regulation for Health Technology”.

Over the years, the number of wireless devices launched towards healthcare has skyrocketed. In April 2018, Anvisa issued a technical notice to clarify that these types of devices and its accessories also require Anatel homologation. The homologation is an essential step for completing the registration of your product with Anvisa, which means that without a valid homologation or proof that the product is in accordance to the local telecommunication regulation, your Anvisa registration will not be granted.

You will not need to present Anatel certificate in order to register your company with Anvisa, but to request Anvisa product registration, you should already have the homologation in hands.

To be homologated by Anatel, the product requires a certification, which is issued by the OCD after the product undergoes laboratory tests on samples to ensure it meets the local regulations. Anatel tests include:

• Product functionality
• Emission levels
• Electrical safety

What Medical and healthcare products require homologation from Anatel

There is a vast range of products that are subject to certification and further homologation by Anatel to be approved by Anvisa. Among equipment and devices that need to undergo the homologation process with Anatel are:

• All versions of Bluetooth, including low power
• RFID readers
• Wi-Fi, both 2.4 GHz and 5.8 GHz
• Any devices that use RF modules
• Devices that connect to the mobile network using GPRS, Edge, 3G, LTE, WiMax or 5G
• LPWAN gateways and endpoints

The list of products that fall into these categories is extensive, ranging from devices like wireless glucose monitors and smart scales, to more comprehensive multi-sensors systems for assisted nursing homes to monitor the overall well-being of senior’s health.

Summary of the homologation process with Anatel

Once you figured out that your product requires Anatel homologation, the first step is the contact an OCD, which is an independent company authorized by Anatel to conduct certification processes for telecommunication products. Master Certificações is an OCD with an extensive experience in homologating a range of products, including wireless electromedical devices, and will be able to provide you with professional advice regarding your certification process.

The OCD will need access to the technical specification, datasheets, and other additional information so they can determine the exact documents and tests required by Anatel for your specific device. The tests and the time that it will take for conclusion by the laboratory will vary greatly depending on the wireless technology, whether your product uses batteries, etc.

The following step for the certification requires the laboratory testing on the product samples you have supplied. The results will be then returned to the OCD, which will verify whether the product complies with local regulation.

If the product is in accordance with all standards, the OCD will issue a conformity certificate. At this stage, your OCD would already have determined together with you the best location for your Anatel stamp, which can be either in the product itself or the product manual if there is no space to place it within the product.

The final stage is to submit the conformity certificate to Anatel. The agency uses this certificate as the base for your homologation, but additional documents are also required at this stage, including manufacturer documents, stamp containing the Anatel homologation code, translated manuals (shall the product be commercialized towards the B2C market), warranty information, etc.

Upon analysing the documents, Anatel will finally issue the homologation and register the product on Mosaico, which is their public databases.

As you see, you will need a lot of support from your OCD, so it is recommended to choose one with good track records of successful homologation process with Anatel. Master Certificações has over a decade of experience in certification processes and helped several hundreds of foreign business to obtain the homologation for their products in Brazil.