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.

To register a Class I medical device with ANVISA (Brazil's National Health Surveillance Agency), the process is relatively straightforward compared to higher-risk devices, but it still requires adherence to specific regulatory requirements.

In Brazil, the Agência Nacional de Vigilância Sanitária (ANVISA) regulates the safety and efficacy of medical devices. The classification of medical devices in Brazil follows risk-based criteria, where Class I medical devices are considered low-risk products. These devices generally require fewer regulatory requirements compared to higher-risk categories (Classes II, III, or IV).

Verify that the device is classified as a Class I medical device according to ANVISA’s classification rules. Class I devices are typically low-risk products with minimal regulatory requirements.

Obtaining Class III medical device registration with Brazil's ANVISA typically takes 12 to 18 months, although the timeline can vary depending on several factors such as the complexity of the device, completeness of the application, and any additional requirements like inspections.

No, Class III medical device registration with Brazil's ANVISA does not require annual renewal. However, it is important to note that medical device registrations in Brazil are valid for a period of 5 years from the date of approval.

Class III medical device registration with Brazil's ANVISA offers several key benefits, particularly for manufacturers and companies looking to enter or expand in the Brazilian healthcare market. The Class III category represents high-risk devices, so obtaining approval from ANVISA is a significant milestone that provides both market access and regulatory assurance.