ANVISA Medical Device Registration in Brazil

Information

Brazil is the largest medical device Market in Latin America, and it has a well-established but rather complex regulatory system. Before marketing medical devices in Brazil the products must comply with ANVISA`s (Brazilian Health Surveillance Agency) requirements. The application and regulatory requirements vary depending on the device`s classification. As such, the correct classification of your device is essential. DOMO Salute has the knowledge and expertise to work out the correct classification for your device (medical devices, in vitro diagnostics, combination products, software as medical device and health and wellness products) and to assist with every step of the preparation and submission of your application. To take the appropriate time to understand your product means that from the beginning you will know exactly the paths your product will take and the total cost of the project.