Australia

Medical Device Registration

Understanding Australia Medical Device Regulations

At Asia Actual Australia, we specialize in navigating the intricate landscape of Medical Device and In-Vitro Diagnostic regulations overseen by the Therapeutic Goods Administration (TGA), a division of the Australian Government’s Department of Health. For non-Australian companies aiming to register a Medical Device in Australia, selecting a sponsor is a crucial step. As your dedicated sponsor, we act as your primary contact, facilitating the entire registration process with the TGA to ensure compliance and successful market entry.

We ensure compliance with the precise definitions and requirements set forth by section 41BD of the Therapeutic Goods Act 1989 (the Act). This Act provides the legislative framework for consistent national regulation of goods used in the prevention, diagnosis, curing, or alleviation of diseases, ailments, defects, or injuries.

In summary, medical devices under this Act:

Are intended for use in humans;
Aim to diagnose, prevent, monitor, treat, or alleviate a disease or injury, or modify or monitor the body’s anatomy or physiological functions;
Generally achieve their intended purpose through physical, mechanical, or chemical actions.

Reference Countries

Canada – European Union – Japan – United States – Singapore

How to Register Your Medical Device in Australia

Manufacturers seeking ARTG inclusion will need to provide evidence of acceptable certification from the TGA or other Conformity Assessment Body (CAB), such as a European Notified Body. Conformity assessments require the manufacturer to show compliance with the Essential Principles, which consist of six fundamental requirements and an additional nine that are applied on a case-by-case basis. Manufacturers without a local office in Australia will need to work with an Australian Sponsor to submit applications, answer questions, and provide post-market surveillance support.

Products that have already demonstrated conformity through one of the below routes can utilize their certification as evidence of conformity to the Essential Principles and bypass the full review process, though a Level 1 or Level 2 audit may still be required:

Certificates issued by Notified Bodies designated by the medical device regulators of European member states;
Decisions by the United States Food and Drug Administration (FDA);
Approvals and licenses issued by Health Canada;
Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB);
Certificates and reports issued under the Medical Device Single Audit Program (MDSAP);
ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022);
ISO 13485:2016 certificates issued by a body that is an accredited body and a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022).

The six general Essential Principles apply to all devices:

Use of medical devices not to compromise health and safety;
Design and construction of medical devices to conform to safety principles;
Medical devices to be suitable for intended purpose;
Long-term safety;
Medical devices not to be adversely affected by transport or storage; and
Benefits of medical devices to outweigh any side effects.

There are a further nine Essential Principles regarding design and construction that apply to devices on a case-by-case basis:

Chemical, physical and biological properties;
Infection and microbial contamination;
Construction and environmental properties;
Medical devices with a measuring function;
Protection against radiation;
Medical devices connected to or equipped with an energy source;
Information to be provided with medical devices;
Clinical evidence; and
Principles applying to IVD medical devices only.

Products manufactured in Australia (except Class I), containing medicines or substances of animal, biological or microbiological origin, along with Class 4 IVD medical devices, will require an additional review and certificate from the TGA.

Registering a Medical Device in Australia with the TGA

Medical Device Market Access in Australia

Medical devices with overseas certification or approval will be eligible for an abridged regulatory review as long as it is for the same design, intended purposes, and indications.

Medical Device Classification	Application Fee	Est. Review TGA Time	Schedule 5 Part 1
Class I – sterile or measuring function	$1,060	4 weeks	Item 1.5(e)
Class I – other (excluding export only devices)	$550	Same Day	Item 1.5(g)
Class IIa	$1,060	4 weeks	Item 1.5(g)
Class IIb	$1,060	6 weeks	Item 1.5(c)
Class III	$1,370	6 months (including application audit)	Item 1.5(b)
AIMD	$1,370	6 months (including application audit)	Item 1.5(a)

Application Audit Assessment Fees

Higher-risk products (Class III and AIMD) are required to undergo a mandatory Level 2 audit by the TGA, and this information must be provided within 20 working days of request. Level 1 applications audits are determined on a case-by-case basis.

Type of Application Audit	Assessment Fee	Est. Review Time	Schedule 5 Part 1
Level 1 – verification of sponsor’s application and evidence of conformity	$3,990	2 Months	Item 1.13
Level 2 – Level 1 activities plus review of clinical evidence, risk management, and efficacy and performance data	$7,310	6 Months	Item 1.14

*The application audit assessment fee is in addition to the application fee for the inclusion of some medical devices in the ARTG.

Once approved, it will be important for manufacturers with qualifying devices to then list on the Prostheses List, which allows for easy reimbursement.

Medical Device Annual Fees

Medical Device Classification	Fee	Regulation
AIMD	$1,200	Item 7(4)(d)
Class III	$1,200	Item 7(4)(d)
Class IIb	$940	Item 7(4)(c)
Class IIa	$940	Item 7(4)(c)
Class I – sterile	$640	Item 7(4)b
Class I – measuring function	$640	Item 7(4)(b)
Class I – other	$90	Item 7(4)(a)

Finding an Australian Sponsor

To change the Australian Sponsor associated with an ARTG listing, the existing sponsor must complete, sign, and submit a transfer form to TGA. After the transfer is complete, the new Australian Sponsor must take the following steps:

Submit manufacturer’s evidence (no TGA fee).
Prepare and submit Device Change Requests to update the ARTG entries with the manufacturer’s evidence (TGA fee is $360/application, and the TGA allows up to 10 ARTG entries per application).

Quality System Requirements

Per the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, the TGA requires manufacturers to meet ISO 13485:2016 standards with additional requirements for products sold sterilized. Products using ethylene oxide will need to adhere to ISO 11135:2014, products sterilized with radiation to ISO 11137:2006, and aseptic products to ISO 13408.

Benefits of Independent License Holding through Asia Actual in Australia

Sell directly to multiple regional distributors, avoiding markup by a national importer.
Increase transfer pricing.
Improve leverage in distributor negotiations/responses.
Add or change distributors as required.
Keep intellectual property away from local commercial agents.
Assure expert handling of post-market vigilance and license maintenance.
Neutral package labeling.

Contact Asia Actual for fast and efficient Australia device registration by an experienced local regulatory professional.

What is required to register a medical device in Australia?

Devices must comply with Therapeutic Goods Administration (TGA) standards, include an Australian sponsor, and meet conformity assessment requirements.

What role does an Australian sponsor play in the registration process?

A sponsor facilitates the registration, ensuring the device complies with local regulations and remains in the Australian Register of Therapeutic Goods (ARTG).

Can international approvals expedite the registration process?

Yes, approvals from major markets (like the US, EU, or Canada) can support and streamline TGA registration.

What are the fees associated with medical device registration in Australia?

Fees vary depending on the device class and audit requirements. It includes application, annual, and government fees.

What is the application audit process for higher-risk devices?

Class IIb and Class III devices undergo an audit where technical documentation and evidence are reviewed.

How do I change my Australian sponsor?

To change an Australian sponsor, both the existing and new sponsors must complete and submit the appropriate transfer request forms to the TGA. The new sponsor will take on regulatory responsibilities, and the product must remain listed on the Australian Register of Therapeutic Goods (ARTG) throughout the process.

For more detailed information, visit the TGA page on changing sponsors.

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