Class I device registration is generally valid for five years from the date of approval by ANVISA.

Obtaining Class I medical device registration with Brazil ANVISA offers several important benefits, particularly for companies looking to enter or expand within the Brazilian medical device market. These benefits are primarily related to regulatory compliance, market access, and business growth in one of the largest healthcare markets in Latin America.

The processing time for Class I medical device registration with Brazil ANVISA is generally faster compared to higher-risk devices because Class I devices are considered low-risk and follow a simplified registration process. However, the exact timeline can vary depending on several factors, including the completeness of the application and the efficiency of the review process.

Class I medical device registration with Brazil ANVISA refers to the process by which low-risk medical devices are officially approved for sale and use in Brazil. Class I devices are subject to a simplified regulatory pathway due to their minimal risk to patient health and safety.

To register and apply for Class I medical device registration with Brazil ANVISA, you will need to follow a clear process outlined by the Brazilian Health Regulatory Agency (ANVISA). Class I devices are low-risk and typically follow a Cadastro (Notification) procedure, which is simpler than the more complex registration processes for higher-risk devices.

The application procedures for Class I medical device registration with Brazil ANVISA involve a series of steps, which are generally simpler than for higher-risk medical devices. Since Class I devices are low-risk, they follow the Cadastro (Notification) Pathway under Brazil’s medical device regulations.

Confirm Class I Classification: Ensure your device is classified as Class I (low-risk) under ANVISA’s classification system. Use RDC 185/2001 to check the classification criteria for low-risk devices.

The timeline for Class I medical device registration with Brazil’s ANVISA is generally shorter and more straightforward compared to higher-risk devices. Since Class I devices are low-risk, the application process follows a Cadastro (notification) pathway, designed to be less complex.