Key considerations in navigating the regulatory process to register a medical device in Australia.
Registering a medical device in Australia is a complex but crucial process that ensures the safety and performance of devices entering the healthcare market. Navigating the regulatory requirements of the Therapeutic Goods Administration (TGA) can be daunting, particularly for new manufacturers and innovators.
The expert regulatory consultants at the Adjutor Healthcare Group understand these requirements and will work with you to apply these to your specific business situation.
Overview: Australia’s Medical Device Regulatory System
The Therapeutic Goods Administration (TGA) is the governing body for Australia’s medical device regulatory system.
The Australian Regulatory Guidelines for Medical Devices (ARGMD), provides information on the import, export and supply of medical devices within Australia.
Essentially, the TGA medical devices regulatory system classifies devices based on the level of risk imposed to patients, sets out essential principles for safety, performance and quality, provides a conformity assessment process for compliance and implements regulatory controls for manufacturing processes.
Unless exempt or excluded, medical devices in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG)
A local TGA sponsor is responsible for applying to the TGA, on your behalf, to have your medical device included on the ARTG
We can provide in-country caretaker, Marketing Authorisation Holder, Regulatory Agent and Sponsor Services.
Ready to get started on your project? – Contact our team of TGA specialists today…
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The following, outlines some further regulatory considerations for the inclusion process, and what you need to know before you apply.
Considerations for Medical Device Registration in Australia –
- Why include Australia in your development plan?
- Is your product a “medical device”?
- Device risk classification
- Conformity Assessment
- Device registration (ARTG listing)
- Responsibilities of device sponsors
Why include Australia in your development plan?
Device registration in Australia will grant you access to a market with an estimated population of 26 million with an above average wealth, allowing you to benefit from a well-established regulatory landscape that promotes transparency and mutual recognition of several major overseas markets. Furthermore, an Australian registration in the APAC region can facilitate product registrations in Southeast Asian countries (e.g. Singapore, Malaysia, Thailand, Indonesia, and Vietnam, etc). This approach not only accelerates your device’s regulatory approval but also enhances its global marketability and trustworthiness.
Before any medical device can be placed on the market, it must be included on the Australian Register of Therapeutic Goods (ARTG) via an application to the federal agency, the Therapeutic Goods Administration (TGA).
Is your product a “medical device”?
To determine this, the device description and its intended purpose should be reviewed against the TGA definition of a medical device. The TGA recognises that some products may be considered to be borderline cosmetics/medicines/disinfectants and additional guidance is available on the appropriate registration pathway in these cases.1,2
Some medical devices may be exempt or excluded from inclusion on the ARTG. Excluded devices are not regulated by the TGA and do not require registration3. Exemption means that the TGA will retain some oversight, but the device does not have to go through the full inclusion process. Some clinical decision support software products are good examples of exempt devices.
Device risk classification
Similar to the frameworks in the US or EU, the TGA has adopted a risk-based approach for the classification of medical devices. This ensures that the level of regulatory oversight aligns with the potential risk posed by the device to the user, such as, the level of invasiveness and period of use. Generally, device risk categories in Australia are aligned with those in major markets, but there are country-specific differences. Confirming your device’s risk classification in Australia is imperative.
The TGA medical device classifications are summarised below –
| Device Classification | Level of Risk to User | Examples |
|---|---|---|
| Class I Class Is (sterile) Class Im (with measuring function) |
Low |
Non-invasive, general devices.
E.g. bandages, gowns, scissors, hypodermic needles or measuring cups, etc.
|
| Class IIa / IIb | Moderate / Medium |
Devices that are invasive, or active (programmable) or administer medicine via inhalation or via skin.
E.g. Endoscopes, ventilators, infusion pumps, catheters, asthma inhalers, spacers.
|
| Class III | High |
Implantable devices or those incorporating medicine (as a secondary mode of action) or substances from human, animal, or recombinant origin.
E.g. Hip implant, dermal filler (cosmetic) injections.
|
Conformity Assessment
Manufacturers of medical devices (except Class I manufacturers) must demonstrate compliance with ISO 13485 for their Quality Management System (QMS) and with the TGA Essential Principles.
The QMS standard ensures that the necessary procedures are followed during design, manufacture, testing and post-marketing, whilst the Essential Principles require that appropriate technical documentation is held by the manufacturer to substantiate the device claims of safety and performance. Conformity Assessment is a systematic and ongoing examination of this evidence and procedures of the manufacturer by a third party to verify that the device is suitable for market and to support device registrations.
Traditionally, the TGA issued such Conformity Assessment certificates. This process can be long (~1 year)4 and expensive (AUD34999 for Class II and AUD100,849 for Class III devices)5. The TGA now aims to foster a regulatory environment that promotes mutual recognition of overseas Conformity Assessment evidence6, enabling quicker patient access by recognition of an assessment made by another recognised regulatory body. Therefore, certain overseas evidence recognised by the TGA may be able to support device registrations in Australia, such as EC certificates, Medical Device Single Audit Program certificates (MDSAP) and device registrations in US, Canada, EU, Japan, or Singapore7.
Device registration (ARTG listing)
Devices with appropriate Conformity Assessment evidence can be considered for inclusion on the ARTG and following TGA approval, they can be supplied in Australia. Device applications are made for a “kind of medical device”, which allows low to medium risk devices to be grouped by defined characteristics under one ARTG entry, rather than requiring each product to have its own separate entry in the ARTG.
Registration is a two-step process. Submission of the manufacturer’s evidence is processed quickly, usually within a couple of weeks and with no associated fee. Following this, the device application can be submitted, where specific device details are provided. The device risk classification, intended purpose of use, GMDN code, any supporting documents, and a cross-reference to the manufacturer’s evidence is submitted. This application incurs a small agency fee.
TGA evaluation timelines can vary greatly. If the Conformity Assessment evidence was issued by the TGA or by an EU MDR notified body, it may be processed within a month. Applications with any other type of Conformity Assessment evidence may be selected for an application audit to verify that the devices meet the relevant requirements. For some applications, this selection is mandatory under the legislation, while for others, it is at the discretion of the TGA. Although there are no published target timeframes for application audits, they can often take between 4 and 12 months.
Responsibilities of device sponsors
Any application to the TGA must be made by the sponsor, a local, Australian entity. The sponsor is responsible for the device in Australia and must comply with a range of regulatory obligations, including any conditions of approval imposed on the devices while they remain on the ARTG9. The Adjutor Healthcare group routinely acts as the sponsor for its clients who do not have a legal entity in Australia.
The higher the risk category of the device, the stricter the TGA requirements are for safety and post-marketing surveillance. The sponsor is responsible for reporting adverse events, liaising with the manufacturer to obtain regulatory information, maintaining Australian distribution records, ensuring labelling and advertising is compliant with Australian legislation, and providing annual device vigilance reports for the highest risk devices.
How can a regulatory consultant help you?
Partnering with the Adjutor Healthcare Group can provide invaluable support, expertise, and efficiency, ultimately enhancing the success of your medical device, including:
- Tailored guidance: Our consultants can provide hands-on assistance with all aspects of the process including product classifications, gap analysis of your manufacturer evidence, conformity assessments, streamlined product registration, sponsorship support, ARTG approvals, and post-approval support (including distribution advice).
- Expertise and knowledge: We possess in-depth knowledge of the complex and ever-changing regulatory landscape, ensuring compliance with all relevant local and global standards and guidelines; Compliance is the cornerstone of how you build trust and credibility with your key stakeholders.
- Global support: Our consultant can assist you expand into new markets by developing a global strategy that meets your needs.
For more information regarding medical device registration in Australia, contact our team of regulatory professionals for expert advice.
References:
1Some examples of articles that are not medical devices: disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides, In-vivo imaging agents injected, ingested, or otherwise instilled into the body, etc. For the full list, refer to : Federal Register of Legislation – Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023.
2Borderline products that are considered medical devices include non-sterile personal protective equipment or safety apparel intended to be used for the prevention of the transmission of disease between persons, or the restoration of teeth by dentist. For the full list, refer to: Federal Register of Legislation – Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020.
3Some examples are the consumer health and wellness product not intended to manage serious conditions, such as a wearable that allows the wearer to track their heart rate for fitness; or behavioural change or coaching software for improving general health parameters, etc. For the full list, refer to : Examples of regulated and unregulated software (excluded) software based medical devices (tga.gov.au)
4TGA FY22/23 Annual Performance Report
5TGA Fees and Charges Summary FY 24/25
6Comparable overseas regulators for medical device applications | Therapeutic Goods Administration (TGA)
7Federal Register of Legislation – Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
8Devices are taken to be of the same kind if they have the same Sponsor, Manufacturer, Classification and Global Medical Device Nomenclature System Code (GMDN code) and for the highest risk devices, the same unique product identifier (UPI). What ‘kind of medical device’ is it | Therapeutic Goods Administration (TGA)
9Obligations of new sponsor | Therapeutic Goods Administration (TGA)
