Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and x-ray equipment. They differ from medicines as they generally have a physical or mechanical effect on the body or are used to measure (or monitor) the body and its functions. While the objective of these products is to help improve your health and wellbeing, it's important to know that their use also has potential risks.
The higher the potential risks of a medical device, the more they need to be examined and monitored. The level of risk that is identified determines:
- what type of evaluation the TGA needs to carry out
- the amount and type of information the TGA needs to review
- the degree of scrutiny necessary before the product can be made available in Australia.
For example, high-risk devices (such as pacemakers) involve a direct evaluation of the available scientific evidence by TGA Officers.
How does the TGA approve medical devices?
A sponsor of a medical device must apply to the TGA to include their device on the Australian Register of Therapeutic Goods (ARTG). A sponsor is a person or company who is legally responsible for supplying a medicine or medical device. The TGA then applies a risk-based approach to assessing and approving a device for use in Australia. The TGA reviews the evidence at hand and request expert advice to determine whether the benefits of the device outweigh any possible risks.
Medical devices must be included in the ARTG before they can be lawfully sold in Australia.
Classification of medical devices
Medical devices will be placed into one of the main classifications depending on the level of risk they pose. The higher classification level, the tougher the requirements will be.
Devices are classified by considering a number of different questions, such as:
- What does the manufacturer intend the medical device to be used for?
- How invasive will it be in the body (e.g. is it a bandage to be placed on the skin, or a catheter to be 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 |
|
How do I know that my medical device is safe?
No medicine or medical device is completely safe and without risks and side effects, but the TGA takes a number of steps to minimise the potential risks as much as possible. The Australian public should feel confident in the safety and quality of approved medical devices in Australia, with our regulatory requirements for medical devices amongst the most stringent in the world. Medical devices in Australia are not only subject to strict approval assessments but are also monitored closely after they have been approved for supply and included in the ARTG.
The Essential Principles
Part of these requirements involves six general principles that all devices must comply with. These relate to health and safety, including long-term safety and a focus on making sure the benefits outweigh the risks. A further nine principles relating to design and construction apply to devices on a case-by-case basis.
Proper compliance with these principles ensures devices are as safe as possible and perform as intended. Once a device is approved, the manufacturer is expected to continue to monitor the performance and safety of their device, and make sure it continues to comply with the Essential Principles.
Reforms
The Australian Government has been undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia.
An Action Plan for Medical Devices (Action Plan), released in 2019, is a three-part strategy to strengthen Australia’s regulatory system, whilst continuing to be patient focused and have greater transparency, and increase public confidence in Australia’s medical device regulatory system.
The three strategies outlined in the Action Plan 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
The Medical Device Consumer Working Group and Women’s Health Products Working Group support the Action Plan.
Post-market monitoring
The TGA monitors medical devices even after they are approved for use in Australia to make sure they continue to meet our safety standards and regulatory requirements. This is known as 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
- conducting periodic inspections of manufacturers
- requiring manufacturers and sponsors to report adverse events and other information involving their medical devices within specific timeframes.
Reviewing adverse event reports is just one way that the TGA monitors the safety of therapeutic goods used in Australia.
The TGA collects these reports in a database, and regularly monitors them to identify a spike or unusual trend. A risk assessment is undertaken by a panel of clinicians and scientists within the TGA to determine if an investigation is required, and the TGA may also obtain expert advice. The investigations may result in product recovery (recalls), hazard and safety alerts, product modification/improvement by a manufacturer, or surveillance audits of manufacturing sites.
How you can help
All reports to the TGA contribute to gaining a better understanding of the possible (or previously unknown) adverse effects of a medical device once it's more widely available. It doesn't matter whether you are a health professional or a patient, or a patient's carer. Your report could help make a difference.