The fees and costs for the registration of medical devices in Australia can vary depending on the classification of the device and the type of application. The Therapeutic Goods Administration (TGA) sets fees based on the regulatory activities involved in the assessment and monitoring of medical devices. Here is a general overview of the fees:
1. Application Fees: These fees are payable at the time of submission of the application and vary depending on the classification of the device and the type of application (e.g., new application, change in classification, etc.).
2. Annual Charges: Once a medical device is included in the Australian Register of Therapeutic Goods (ARTG), annual charges apply for the maintenance of the registration. These charges are based on the risk classification of the device.
3. Other Fees: Additional fees may apply for certain activities such as variations to the registration, requests for priority review, and inclusion of additional information.
It's important to note that fees are subject to change, and manufacturers should refer to the latest TGA fees and charges schedule for accurate information. Fees are typically payable in Australian dollars (AUD) and can be paid online through the TGA's eBusiness Services portal.
For more detailed information, you may want to visit the official website of the Therapeutic Goods Administration or speak with Artixio Expert
