The timelines for the review and approval of medical devices in Australia can vary depending on several factors, including the classification of the device, the completeness of the application, and the workload of the Therapeutic Goods Administration (TGA). However, the TGA aims to process most applications within certain target timeframes:
1. Class I Non-sterile, Class I IVDs, and Custom-made Medical Devices: Typically, these devices are not subject to TGA review and can be placed on the market immediately after self-certification by the manufacturer.
2. Class IIa, IIb, III, and Active Implantable Medical Devices: The TGA aims to process these applications within 255 calendar days.
3. In vitro Diagnostic (IVD) Medical Devices: The TGA aims to process these applications within 255 calendar days.
These timelines are targets and actual processing times may vary. It's important for manufacturers to submit complete applications and respond promptly to any requests for additional information to help expedite the review process.
For expedited review, the TGA offers Priority Review and Provisional Approval pathways for certain medical devices that address an unmet clinical need or public health priority. These pathways may result in shorter review times.
It's recommended to consult the TGA website or contact the TGA directly for the most up-to-date information on review and approval timelines for medical devices in Australia.
