To register a Class III medical device with Brazil's ANVISA, you must prepare and submit a comprehensive set of documents that demonstrate the device's safety, efficacy, and compliance with local regulatory standards.

The registration process for Class III medical devices with Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) is a detailed and highly regulated procedure. Class III devices are considered high-risk and require comprehensive documentation and evidence to ensure their safety, efficacy, and quality.

To apply for Class III medical device registration with Brazil's ANVISA, you will need to submit your application through ANVISA’s electronic system known as Solicita. This system is used for managing all medical device registrations, including for Class III devices.

ANVISA Registration Fee: The registration fee for a Class III device can vary depending on the applicant type. For example, large foreign companies generally pay higher fees, whereas small or local companies may qualify for reduced rates.

Registering a Class III medical device with Brazil’s ANVISA involves meeting strict requirements that focus on safety, quality, and compliance with local regulatory standards. Class III devices are typically high-risk products, and ANVISA requires comprehensive evidence to ensure these devices are safe for use in Brazil.

Non-Brazilian companies are required to designate a local entity, known as a Brazilian Registration Holder (BRH), who will be legally responsible for the device within Brazil. The BRH acts as the official liaison with ANVISA.

In Brazil, Class III medical devices are high-risk products regulated by ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian health regulatory agency. These devices often support or sustain human life, have significant potential health impacts, and thus are subject to stringent controls. Examples include implantable devices, certain diagnostic tests, and life-supporting equipment.

Non-Brazilian companies must partner with a local Brazilian entity, known as a Brazilian Registration Holder (BRH). This entity will be legally responsible for the product in Brazil.