A Complete Guide to Licensing Medical Devices in Australia
This guest article was brought to you in conjunction with Access-2-Healthcare, a global consulting company that helps to overcome various challenges faced by medical technology companies by executing end-to-end market entry and product launch activities in various countries.
- Medical Device Risk Classification
- Australian TGA Sponsor
- Pre-market Assessment: Manufacturer Evidence
- Pre-market Pathways
- Timeframes for Inclusion on ARTG
- Fees for ARTG Inclusion
- Submission Requirements
- Global Medical Device Nomenclature (GMDN)
- IVD Registration in Australia
- Software as a Medical Device (SaMD) Registration in Australia
- Importation of Medical Devices into Australia
- Next steps
Australia medical device regulations are one of the most mature, pragmatic regulations in the world. Medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA) in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.
These regulations read out how medical devices are classified and registered in Australia. All medical devices, unless exempt or excluded under the Act, must be included in the Australian Register of Therapeutic Goods (ARTG) prior to import, supply and/or export from Australia.
Medical Device Risk Classification
The risk classification of each medical device depends on the claims made by the Product Owner based on its intended purpose.
Medical devices are defined by Section 41BD of the Therapeutic Goods Act 1989 (the Act), as any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- control or support of conception;
- in vitro examination of a specimen derived from the human body for a specific medical purpose;
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
(aa) any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or (ab); or
(c) a system or procedure pack.
Medical devices are classified according to the level of harm they pose to patients and users – Class I, Is, Im, IIa, IIb and III; Class I being the lowest risk and Class III the highest risk. IVDs, on the other hand, are classified as Class 1, 2, 3 and 4.
Australian TGA Sponsor
Manufacturers must appoint an Australian TGA Sponsor if they do not have a local presence in Australia. The Sponsor acts as the liaison between the manufacturer and TGA and facilitates device registration. The Sponsor’s name and address must appear on the manufacturer’s device labelling. It is highly recommended that appoint a 3rd party Sponsor who is not commercially involved in the sale of your devices and acts solely as your regulatory representative in Australia. The Sponsor must be an Australian resident or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.
Pre-market Assessment: Manufacturer Evidence
Conformity assessment is the systematic examination by the manufacturer to determine the acceptability of medical device safety and that the device performs as intended. This is demonstrated by providing appropriate certificate issued to the manufacturer by an appropriate assessment body for the quality management system (such as an ISO13485 or MDSAP certificate) and evidence of conformity assessment of the product by an overseas regulator such as the EC Certificate or Health Canadat Certificate.
- Conformity Assessment
A systematic examination of evidence and procedures which ensures medical device compliance with the essential principles is called conformity assessment. Depending on the classification of a device, there are different conformity assessment procedures a manufacturer may use to demonstrate compliance with the Essential Principles.
The conformity assessment procedures, including Australian declaration of conformity requirements, are detailed in Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
- Mutual Recognition Agreement via CE mark
Australian regulatory arrangements closely match those applying in Europe, with both systems aligned with the Global Harmonisation Task Force (GHTF) framework. Applications for marketing approval in Australia rely heavily on CE mark, hence a Mutual Recognition Agreement (MRA) is in place between both countries, which provides mutual acceptance of conformity assessment for medical devices.
However, this mutual recognition does not mean your product is exempt from registering with the TGA, or that it confers ‘instant approval’. You would still need to provide manufacturer’s evidence, and provide the rest of the technical information for product registration.
- Mutual Recognition Agreement via other reference countries
In addition to CE mark, the TGA recognises a range of internal assessments and approvals from other comparable overseas regulators such as decisions of US FDA, approvals and licenses issued by Health Canada, reports and certificates issued under Medical Device Single Audit Program (MDSAP) – therefore ISO13485 or compliance to the US FDA’s QSR is not enough – and pre-market approvals from Japan MHLW. When using overseas evidence considerations, the device must have the same design and intended purpose, intended for the same indications.
Timeframes for Inclusion on ARTG
Applications and conformity assessment timelines can vary on the risk classification of the device. Generally, the higher the risk of the device, the longer it takes to provide a thorough evaluation of its safety and effectiveness. The table below entails the turnaround time for registration routes in working days:
|Class I||24 hours*|
5 – 80 business days*
In-vitro Diagnostics (IVDs):
|Class 1||24 hours*|
|Class 2||20-60 business days*|
|Class 4||5 business days|
*Depending on whether an application audit is required. Application audits conducted are generally limited to the product technical file and often referred to by the TGA as Technical File Reviews (TFRs).
Fees for ARTG Inclusion
(Sterile or Measurement)
IVD Medical Devices:
All classes of IVD
(Class 1 – 4)
- Manufacturer Evidence
- Declaration of Conformity
- GMDN code and description
- TGA Conformity Assessment Certificate, overseas market authorisation evidence from a comparable overseas or certificate issued under Mutual Recognition Agreement (MRA)
- Declaration of Conformity
- Medical Device Labels
- Instructions for Use
- Clinical Evidence
- Essential Principles Checklist
Global Medical Device Nomenclature (GMDN)
GMDN is an international nomenclature system used by regulatory bodies to consistently describe medical devices. GMDN terms are made up of a 5-digits numeric code, term name and definition. Manufacturers are responsible for choosing the most appropriate GMDN term for all medical devices they manufacture. In an event TGA finds that the GMDN term used is unsuitable, the application for inclusion in the ARTG may be rejected.
Nowadays the GMDN Agency is where you can search and/or apply for the most appropriate GMDN Code for you.
IVD Registration in Australia
Depending on the IVD classification (Class 1, 2, 3 or 4), there are different processes need to be followed.
|Class 2, 3 & 4|
|Intended for export only|
Class 1, 2 & 3 in-house IVD medical devices are required to be entered on an in-house IVD database that is separate from the ARTG. Refer to Part 6A in Schedule 3 of the Regulations.
Software as a Medical Device (SaMD) Registration in Australia
Recent reforms have been implemented to clarify the requirements for regulated software-based medical devices, including introducing several exclusions and exemptions for specific types of software products. The Therapeutic Goods (Excluded Goods) Determination 2018 legislative document describes software exclusion. Excluded products are not medical devices and hence do not need to be included in the ARTG. An exemption has also been introduced for a few Clinical Decision Support Software (CDSS), and registration is not required. However, it is important to note that TGA retains some overnight for advertising and adverse events.
Regulated SaMD is classified according to the level of harm it may pose to users or patients. The higher the classification level, the higher the level of regulatory oversight. It is important for manufacturers to determine the classification of the software –exempt, excluded or regulated – to effectively manage and comply with TGA software requirements.
Importation of Medical Devices into Australia
Wholesalers and importers dealing with medical devices in Australia shall conform to the legal requirements of The Therapeutic Goods Administration as it ensures access to therapeutic goods for the population and protects public health. Medical devices, unless an exemption applies, must be included on the ARTG before they can be supplied in Australia.
Each ARTG entry is unique to the Sponsor, Manufacturer and the kind of device. Therefore, every sponsor needs to apply to the TGA to have their imported medical devices included on the ARTG, even if another sponsor already has an ARTG entry for the same device.
Hope this article gives you a better idea of the first step to market entry into Australia.
Need help with medical device classification, registration and being your Sponsor?
Access-2-Healthcare helps medical device companies end-to-end, with gaining regulatory approvals, market access, post-market management in Australia, and other countries. Find out more about how they can help you here.