Australia

Government Authority

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-Australia based 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.

Medical Device Status

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.

Registering Your Medical Device in Australia

Manufacturers seeking ARTG inclusion will need to provide evidence of an acceptable certification from the TGA or other Conformity Assessment Body (CAB), such as a European Notified Body.  Conformity assessments require the manufacturer show compliance to the Essential Principles which consists of 6 fundamental requirements and an additional 9 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 that is 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.

Quality System Requirements

Per the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, the TGA requires manufacturers 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 ISO 11137:2006, and aseptic products adhering to ISO 13408.

Transferring a Medical Device Listing

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:

1. Submit manufacturers evidence (no TGA fee)
2. Prepare and submit Device Change Requests to update the ARTG entries with the Manufacturers evidence (TGA fee is $360/application and the TGA allows up to 10 ARTG entries per application

Timelines and Fees for ARTG Listings

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(d)
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)

Benefits of Independent License Holding through Asia Actual in Australia

• Sell directly to multiple regional distributors, avoiding mark-up 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.