The standards for Class I medical device registration with ANVISA in Brazil are primarily defined by ANVISA regulations and international standards that ensure the safety, quality, and performance of the device. Since Class I devices are considered low-risk, the standards are generally less stringent than for higher-risk devices. However, they still require manufacturers to demonstrate compliance with certain criteria.

When applying for Class I medical device registration with ANVISA in Brazil, certain technical documents must be submitted to demonstrate the safety, performance, and compliance of the device with Brazilian regulations. Class I devices are considered low-risk and non-invasive, so the technical documentation required is typically less extensive than for higher-risk classes, but it still ensures that the device is safe and effective for its intended use.

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.