Foreign manufacturers must appoint a Brazilian Registration Holder (BRH). This is a local company or individual authorized to represent the foreign manufacturer in Brazil.

For Class I medical device registration with Brazil’s ANVISA, you need to prepare a series of materials and documents to ensure compliance with the regulatory requirements. Below is a detailed list of the materials required and how to prepare the application documents effectively.

To register a Class I medical device with Brazil's National Health Surveillance Agency (ANVISA), you need to follow a series of steps, submit specific documentation, and address key considerations to ensure compliance with Brazilian regulations. Below is a detailed breakdown of the steps, required documents, and important considerations.

To apply for Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA), the application must be submitted through ANVISA's e-Submission System. The system is called SNGPC (Sistema de Notificação de Produtos de Saúde), which is used for registering health products, including medical devices, in Brazil.

The cost and time required for obtaining Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA) are generally lower compared to higher-risk classes. However, the exact duration and fees can vary depending on several factors such as the type of device, the completeness of the application, and the efficiency of the process.

Obtaining Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA) involves meeting specific requirements due to the low-risk nature of these devices.

Verify that your product qualifies as Class I under ANVISA’s classification system. Class I devices are low-risk and have minimal impact on patient health if they fail.

Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA) is a regulatory process designed for low-risk medical devices. These devices require a simpler registration pathway due to their low-risk nature, and this is often referred to as "Cadastro" (registration) rather than "Registro" (higher scrutiny, applicable for higher-risk devices).