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On August 21, 2023, TGA released the latest guidance on the reclassification of medical devices, as follows:
Reclassification of active medical devices intended for therapeutic use with diagnostic functions
The guidance aims to help sponsors of therapeutically active medical devices with diagnostic functions meet their obligations and outlines transition arrangements to help comply with the new regulation.
Guide download link:
Reclassification of medical devices that come into direct contact with the heart, central circulatory system, and central nervous system
The guidance is intended to help sponsors of medical devices intended for direct contact with the heart, central circulatory system (CCS) or central nervous system (CNS) meet their obligations and outlines transition arrangements to aid compliance with the new regulations.
Guide download link:
Reclassification of medical devices for administration of drugs or biological products by inhalation
The guidance is designed to help sponsors of medical devices that deliver drugs or biologics by inhalation to meet their obligations and outlines transition arrangements to help comply with the new regulations.
Guide download link:
Reclassification of medical devices consisting of a substance or combination of substances introduced into the body through a body orifice or applied to and absorbed by the skin
The guidance aims to help sponsors of medical devices that introduce substances in the body meet their obligations and outline transitional arrangements to help comply with the new regulations.
Guide download link:
Reclassification of Spinal Implantable Medical Devices
This guidance is intended to help sponsors and manufacturers of spinal implantable medical devices understand and comply with new regulatory requirements.
The new regulatory requirements will also include:
1. Conduct a more detailed assessment of the manufacturer’s quality management system and an evaluation of the technical documentation associated with each device.
2. Conformity assessment documents demonstrating the procedures applicable to its classification
3. TGA’s mandatory audit evaluation of devices for inclusion in applications, including clinical evidence evaluation
4. Class IIb spinal fusion cages are required to include specific information in the ARTG entry regarding the device provided under the ARTG entry. This includes the product names of all devices under each ARTG entry.
Guide download link:
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