The processing time for Class I medical device registration with ANVISA in Brazil typically ranges from 30 to 90 days, depending on several factors such as the completeness of the application, the volume of applications being processed by ANVISA, and whether additional documentation or clarification is required during the review.

To apply for Class I medical device registration with ANVISA in Brazil, you must meet certain conditions as outlined in Brazilian regulatory requirements. Class I devices are considered low-risk, non-invasive devices that have basic safety and performance standards.

To apply for Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency), you must follow a set process and submit your application via ANVISA’s online platform, the e-PL system (Sistema Eletrônico de Peticionamento de Produtos para Saúde). Below is a step-by-step guide on how to apply for Class I medical device registration and where to apply.

For Class I medical device registration with ANVISA in Brazil, several materials and documents must be prepared to ensure compliance with Brazilian regulations. These documents will be submitted electronically via ANVISA’s e-PL system.

Applying for Class I medical device registration with ANVISA in Brazil involves a structured process, and several key materials and considerations must be addressed. The process is generally more straightforward than for higher-risk devices, but it still requires adherence to specific regulatory guidelines. Below are the process steps, required materials, and key considerations for applying for Class I medical device registration.

To apply for Class I medical device registration with ANVISA in Brazil, you must use the ANVISA electronic platform known as e-PL (Sistema Eletrônico de Peticionamento de Produtos para Saúde). This is the official system for submitting and managing medical device registration applications.

The costs for registering a Class I medical device with ANVISA are relatively modest compared to higher-risk devices. However, they still include administrative fees for processing and registration.

To apply for Class I medical device registration with ANVISA (Brazil's National Health Surveillance Agency), certain requirements must be met. These requirements ensure the device complies with safety and performance standards and follows regulatory guidelines in Brazil.