The fees and costs associated with the registration of medical devices in Brazil can vary depending on several factors, including the classification of the device, the type of application, and the services required. ANVISA's fee schedule includes the following fees that may be applicable to the registration of medical devices:
1. Application Fees: ANVISA charges application fees for the submission of registration applications for medical devices. The amount of the application fee can vary based on the classification of the device and the type of application (e.g., initial registration, renewal, modification).
2. Annual Fees: After the initial registration, manufacturers and importers of medical devices are typically required to pay annual fees to maintain the registration of their devices with ANVISA. The amount of the annual fee can depend on factors such as the classification of the device and the specific regulatory requirements.
3. Technical Service Fees: In some cases, manufacturers may need to engage the services of technical experts or consultants to assist with the preparation and submission of the registration application. The fees for these services can vary based on the scope of work and the expertise required.
4. Other Costs: In addition to the fees charged by ANVISA, manufacturers should also consider other potential costs associated with the registration process, such as the costs of preparing the required documentation, translation services (if applicable), and any fees charged by third-party testing laboratories or certification bodies.
For a detailed information you can visit the official website of Brazil National Health Surveillance Agency (ANVISA) or Speak with an Artixio Consultant.
