In the past few weeks, the Australian Regulatory Authority – the Australian Therapeutic Goods Administration (TGA) – has published some guidelines and important updates on clinical evidence, reclassification of some devices and a project on post-market reporting.
Guidelines on clinical evidence updated
First of all, TGA delivered the updated guidance “Clinical evidence guidelines: Medical Devices”, the goal of which is to provide clarification of clinical evidence requirements for Manufacturers of Medical Devices and IVDR, and to Sponsors (any person, company, institution, or organisation that takes responsibility for initiating, managing, and arranging the financing of the clinical investigation).
The paper focuses specifically on:
- Total or partial joint prostheses.
- Cardiovascular devices.
- Implantable pulse generators.
- Heart valve prostheses.
- Implantable Medical Devices in the field of magnetic resonance imaging.
Reclassification of Medical Devices involved in circulatory and nervous system
TGA published the guidelines “Reclassification of Medical Devices in direct contact with the heart, central circulatory and central nervous system” to reclassify Medical Devices involved in the circulatory and nervous system from class IIa (moderate risk) to class III (high risk).
According to the guidelines, the following devices are reclassified in class III starting from November 25, 2021:
- Medical Devices used in direct contact with the heart and central circulatory system (CCS) and intended for short-term or transient use;
- Medical Devices used in direct contact with central nervous system (CNS) and intended for transient use.
Although the reclassification took effect on November 25, 2021, the following deadlines and transitional arrangements apply:
- With regard to devices included in the Australian Register of Therapeutic Goods (ARTG) within November 25, 2021, Sponsors have to notify the TGA before May 25, 2022, to inform the Regulatory Authority that some devices need to be reclassified in Class III. After that, sponsors, before November 1, 2024, need to apply for their new device to be included in the ARTG as a Class III Medical Device.
- Those sponsors who applied for Class IIa devices to be included in the ARTG before November 25, 2021, must notify TGA within May 25, 2022, to reclassify their devices as a Class III devices. Furthermore, these sponsors need to apply for their device to be included in the ARTG as a Class III devices before November 1, 2024.
- On the other hand, the sponsors who did not apply for their devices to be included in the ARTG within November 25, 2021, must apply for new Class III devices within November 1, 2024.
Lastly, TGA announced on its website a project to enhance post-market monitoring and reporting processes for Medical Devices on the Australian market to ensure safer and efficient products, as well as to improve patient safety and communication between interested parties.
Do you need more information to market your Medical Devices in Australia?
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