Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it.
Medical devices include a wide range of products. For example, medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment.
While we use medical devices to improve our health and wellbeing, there are also potential risks.
The level of risk determines:
- what type of evaluation we need to carry out
- the amount and type of information we need to review
- The level of scrutiny the product needs to pass.
Our role in approving medical devices
To get a device on the Australian Register of Therapeutic Goods (ARTG), the sponsor needs to apply to the TGA.
Medical devices must be included in the ARTG before they can be lawfully sold in Australia.
To approve a device for use in Australia, we use a risk-based approach.
Our team may review the evidence and gets expert advice to see if the device's benefits outweigh the potential risks.
Classification of medical devices
The risk level of medical devices determines their classification. The higher classification level, the tougher the requirements will be.
We classify devices based on:
- What does the manufacturer intend the medical device to be used for?
- How invasive will it be in the body (e.g., is it placed on the skin, or a catheter inserted into the body)?
- Where on (or in) the body will it be used?
- How long will it be used for?
| Risk level | Classification(s) | Examples |
|---|---|---|
| Low | Class I |
|
| Low to Medium | Class I - supplied sterile Class I - with a measuring function Class IIa |
|
| Medium to High | Class IIb |
|
| High | Class III |
|
Keeping devices safe
No medicine or medical device is completely safe and without risks and side effects. We take several steps to minimise the potential risks.
Australians should feel confident about the safety and quality of their medical devices. We have some of the strictest regulations in the world for medical devices.
Australian medical devices are also closely monitored after they're approved for supply.
The Essential Principles
All devices must comply with six general principles. They're called the Essential Principles.
The principles relate to health and safety. They include long-term safety and a focus on making sure the benefits outweigh the risks.
A further nine Essential Principles relating to design and construction apply to devices on a case-by-case basis.
After a device is approved, the manufacturer must:
- continue to monitor the performance and safety of their device, and
- make sure it continues to comply with the Essential Principles.
Reforms
Australia's Government has been reforming the regulation of medical devices.
An Action Plan for Medical Devices (Action Plan) is a three-part strategy to strengthen Australia’s regulatory system.
The strategies outlined are:
- Improve how new devices get on the market
- Strengthen monitoring and follow-up of devices already in use
- Provide more information to patients about the devices they use
Post-market monitoring
We continue to monitor medical devices even after they are approved for use in Australia.
We call this post-market monitoring. Some post market monitoring activities include:
- assessing and investigating reports of problems with medical devices
- checking evidence that medical devices continue to comply with the Essential Principles
- periodic inspections of manufacturers
- requiring manufacturers and sponsors to report adverse events and other information involving their medical devices within specific timeframes.
We monitor the safety of therapeutic goods in Australia by reviewing adverse event reports. We use these reports to identify a spike or unusual trend.
Experts do a risk assessment to determine if an investigation is needed.
Investigations may result in:
- product recovery (recalls),
- hazard and safety alerts,
- product modification or improvement by a manufacturer, or
- surveillance audits of manufacturing sites.
Your role
Adverse events include side effects or reactions caused by therapeutic goods.
If you experience an adverse event or problem related to a medical device, you should submit a report.
Your report could help make a difference.