Answering your questions: How the TGA regulates medical devices in Australia

This TGA behind-the-news article was published on 21 December 2018. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

The Therapeutic Goods Administration (TGA) often receives questions from concerned Australians about the regulation of medical devices. To help answer your questions, we provide this overview of medical devices regulation in Australia.

On this page: The TGA adopts a risk-based approach | Complying with the Australian regulatory requirements is compulsory | Every medical device must meet our list of Essential Principles | Not all medical devices can use evidence from comparable overseas regulators | Accessing expertise | Report adverse events (side effects) to the TGA | You and your doctor can access certain unapproved medical devices | The TGA does not regulate clinical practice | The TGA is committed to continuous improvement

The TGA adopts a risk-based approach

The TGA is responsible for regulating medical devices and other healthcare products such as cells and tissues, medicines, and blood products in Australia.

Medical devices are diverse. Syringes, bandages, condoms, artificial hips, heart valves and pacemakers are all examples of medical devices. As some medical devices pose greater risks than others we classify and regulate medical devices based on their level of risk. If a company wants to supply a medical device in Australia, they must apply to the TGA to have their device included in the Australian Register of Therapeutic Goods (ARTG), a publically available (and searchable) register.

The amount of scrutiny we apply to a medical device before it can be included on the ARTG and made available to Australian consumers depends on its risk classification. More evidence must be provided for devices of higher risk classifications such as pacemakers and joint replacement devices. Less evidence is required to demonstrate that lower classification devices such as bandages are safe and fit for their intended purpose.

The TGA's risk-based approach to medical device regulation means that we focus our resources where they are needed most - on the higher risk devices. This approach also reduces the overall time and cost of approving medical devices, which in turn means faster and cheaper access to medical devices in Australia by patients who need them without compromising public health and safety.

Complying with the Australian regulatory requirements is compulsory

The regulatory requirements for medical devices in Australia are some of the most stringent in the world. Compliance with these requirements and associated activities, like application audits and post-market reviews, is never optional or voluntary. No device is ever automatically included in the ARTG based on an overseas approval - the TGA always makes the final regulatory decision following an appropriate level of review of the device.

The TGA has a range of powers, both before and after a device is included in the ARTG, and can compel sponsor companies to provide information about their device. If that information is inadequate, we have powers to either refuse to allow the supply of a new device in Australia, or cancel the supply of an existing device.

Once a device has been included in the ARTG we continue to monitor its performance to make sure it is working as intended by the sponsor company. When we identify emerging issues with a device, there are a number of actions we can take to address those issues and make sure the device continues to be safe for people to use.

These actions include sending out alerts about a device and, if necessary, recalling the device from the market. When we have evidence that someone has deliberately supplied a device that they know is unsafe, or that doesn't perform as intended, we can take legal action and apply both civil and criminal penalties.

Every medical device must meet our list of Essential Principles

There are a set of Essential Principles documented in law that every medical device must meet before they can be approved for supply in Australia. These principles include:

• safety requirements
• the chemical, physical and biological properties the device must have
• protection from infection and microbial contamination
• appropriate construction and environmental properties
• information to be supplied with the medical device

For very low risk devices, a sponsor can self-certify that their product meets the Essential Principles. The set of very low risk entries are still reviewed by TGA to check that only products of very low risk are self-certified. But for all other devices an independent body must thoroughly assess the device and provide documents to show that the device meets the Essential Principles. This assessment process is known as conformity assessment and it is how a sponsor shows the safety, quality and performance of their medical devices. Conformity assessment can be conducted by the TGA or by a recognised overseas regulatory body, including notified bodies in Europe and the United States' Food and Drug Administration (FDA).

Where an application to include a device in the ARTG is made with conformity assessment evidence from a recognised overseas regulatory body, it may be subject to an application audit. Where the device is a high risk device (Class III or an Active Implantable Medical Device) the application must be selected for audit. An audit of the application may involve a desktop review of information such as the labelling, instructions for use, technical and advertising materials for the device, clinical evidence, risk management documentation for the device, reports from the notified bodies, or microbiology assessment.

Not all medical devices can use evidence from comparable overseas regulators

Recognising the assessments of other regulators helps us achieve efficient regulation of medical devices. For very high risk devices, such as those that include medicines, tissues or cells, the device must be assessed in full by the TGA.

Other higher risk devices that can have conformity assessment evidence from comparable overseas regulators, such as implantable devices, must undergo a further compulsory assessment conducted by us before they will be allowed to enter the market. We can also choose to audit any device before it is approved for supply in Australia.

This process is known as an application audit and adds another layer of assurance that a device meets Australia's regulatory requirements before the device is available to Australian consumers.

The TGA has only recently started accepting US FDA 510k approvals to support applications for some implantable medical devices, and these applications are being subjected to further scrutiny by us to ensure that devices that use this pathway are meeting Australia's requirements.

Accessing expertise

We are responsible for ensuring the quality, safety and performance of all medical devices on the ARTG and to meet this goal we rely on the expertise of a range of in-house assessors, external professionals and the work of comparable overseas regulators and notified bodies.

When we assess medical devices we look at a range of clinical and non-clinical evidence including sterility, engineering, biomaterials and toxicology. To make sure we assess all aspects appropriately, we employ a number of in-house assessors including medical officers, clinicians and engineers from a range of different specialties. We also have our own laboratories to conduct in-house testing.

If our in-house assessors don't have the particular knowledge or specialisation that we need, we're able to seek advice from the Advisory Committee on Medical Devices (ACMD) who provide independent medical and scientific advice to the TGA.

ACMD meets seven times a year, and can be asked to provide us with advice relating to pre-market assessment and/or post-market monitoring. In addition to the ACMD, we have a panel of over 70 experts across many specialties that we can seek advice from, and we frequently invite recognised experts in particular fields including from the Clinical Advisory Groups (who are part of the Prostheses List Advisory Committee) to give us specific advice and assistance.

Report adverse events (side effects) to the TGA

The TGA monitors the safety and performance of medical devices after they have been approved and made available on the market. We use various sources of information in our safety monitoring, including mandatory reporting from the sponsors of medical devices, voluntary reporting from members of the public and healthcare professionals, communications from regulators in other jurisdictions and outcomes of post-market reviews conducted by the TGA.

If you experience an adverse event (side effect) with a medical device, you should report it directly to the TGA. Your healthcare professional may also report the adverse event, but they are not required to do so. If in doubt, report your adverse event directly to us.

We will share information for consumers on our website and social media platforms when a recall action takes place. More information can be found in the recall actions database.

We will also publish useful information for consumers relating to emerging issues. Examples include:

• Metal-on-metal hip implants
• BIA-ALCL - Breast implants and anaplastic large cell lymphoma
• Transvaginal (urogynaecological) surgical mesh hub

You and your doctor can access certain unapproved medical devices

From time to time, you or your doctor may wish to access a medical device that is not included in the ARTG. There are a number of ways to access unapproved products but it is important to understand that an unapproved medical device will not have been thoroughly assessed by the TGA to make sure it meets all the requirements of the Australian regulatory system.

More information about how to access an unapproved medical device can be found on the following web pages:

• Authorised Prescriber Scheme
• Special Access Scheme
• Personal Importation Scheme
• Clinical trials

The TGA does not regulate clinical practice

We make every effort to ensure that every device is safe and fit for its intended purpose before it is made available to you. However, the kind of medical device that is right for you is a decision for you to make together with your doctor.

Before you agree to have surgery you should have a discussion with your doctor about what the surgery entails, the device that will be implanted and the potential risks associated with your device. This process, known as informed consent, is an important step before you agree to have surgery. More information to help you have a discussion with your surgeon before you undergo surgery can be found on the Health Direct website.

The Australian Health Practitioner Regulation Agency regulates Australia's healthcare professionals in conjunction with National and State authorities. They are a good place to start if you have a question about a health practitioner.

The TGA is committed to continuous improvement

The medical device industry is growing and new products coming through as technologies develop.

We are meeting these challenges by:

• addressing recommendations made in the 2015 Review of Medicines and Medical Devices that aim to improve post-market monitoring of medical devices
• participating actively in the International Medical Device Regulators Forum - a group of regulators from around the world that aims to achieve consistency in how medical devices are regulated
• monitoring the performance of devices, reassessing risk and seeking approval from Government to re-classify devices where appropriate so that they will have a higher level of pre-market scrutiny (including surgical mesh and orthopaedic joints)
• addressing consumer information gaps with the introduction of Patient Implant Cards and Patient Information Leaflets to help patients identify the implants they have received and to track their performance
• conducting public consultations to establish the policy and details of proposed changes.

For further information, visit the medical devices overview web page or contact 1800 020 653.