The time required to prepare the application can vary widely depending on the complexity of the device and the availability of required documentation. This can take anywhere from a few weeks to several months.

Correct Classification: Ensure that the device is correctly classified as Class II, which involves a moderate level of risk. The classification is based on the intended use and the risks associated with the device.

Confirm that your device is classified as Class II based on its intended use and associated risks. This classification is crucial for ensuring that you follow the appropriate regulatory pathways.

Detailed information about the device, including its name, model, intended use, design, and functional characteristics.

The process for Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil involves several key steps, and you will need to prepare specific materials for submission. Below is a detailed overview of the process, required materials, and important considerations.

Applications for medical device registration must be submitted through ANVISA's electronic system known as e-ANVISA.

The application fee for Class II medical device registration can range from BRL 1,000 to BRL 2,500 or more, depending on the specific nature of the device and its classification. The exact fee may vary, so it’s advisable to check ANVISA’s official fee schedule for the most accurate information.

Confirm Device Classification: Ensure that your device is correctly classified as Class II, which typically involves a moderate level of risk.