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The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021, some medical devices that are substances for introduction into the body will be required to be reclassified. The new regulatory requirements will also include:
- more detailed assessment of the manufacturer's quality management systems and assessment of technical documentation related to each device
- conformity assessment documents demonstrating procedures appropriate for their classification
- a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
The classification of medical devices that are substances for introduction into the body determines the safety and performance requirements to be demonstrated to meet regulatory requirements.
Contents
- About this guidance
- Background
- Requirements for reclassification
- Medical devices that are substances for introduction into the body
- Examples of devices to be reclassified
- Exceptions
- Examples of devices to be reclassified
- Products that are medicines
- What you need to do
- Medical devices included in the ARTG prior to 25 November 2021
- Applications to include a medical device in the ARTG lodged before 25 November 2021
- Cancelling your ARTG inclusion
- Applications to include a new medical device in the ARTG on or after 25 November 2021
- Application to transition
- Class IIa and Class IIb devices of the same kind
- What to include in your application
- How to submit a reclassification application
- Fees
- Advertising to consumers
- If your inclusion application is not successful
- When to cease supply using your old ARTG entry
Supporting documents
Topics