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What can we do for You?
Many current sponsors and potential sponsors become very confused in what is required to be on the Australian Register of Therapeutic Goods (ARTG) and how do they go about starting.
Firstly you need to understand What is a Medical Device??
From the Therapeutic Goods Act 1989.
What is a medical device?
Medical devices are defined by section 41BD of the Therapeutic Goods Act 1989(link is external) (the Act), and further informed by the Therapeutic Goods (Articles that are Medical Devices) Specification 2014(link is external). You should refer to this definition for any regulatory purpose, including preparing your application.
In summary, medical devices:
- are used for humans
- are intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body
- generally achieve their purpose by a physical, mechanical or chemical action.
For example, implantable prostheses are medical devices due to their function to replace and/or modify the human anatomy and/or a physiological process.
IVD medical devices are also regulated in Australia as a subset of medical devices.
You may wish to check if your product is a medical device using the SME Assist tool .
What is an IVD medical device?
IVD medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002(link is external) (the MD Regulations). You should refer to this definition for any regulatory purpose, including preparing your application.
Typically, IVD medical devices are pathology tests (and related instrumentation) used to carry out testing on human samples where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. IVD medical devices can also be intended for use by a health professional at the point of care or for use by lay persons for self-testing (note, certain IVD medical devices for self-testing are currently prohibited from supply in Australia(link is external)).
Kind of device
Under the Act, a 'kind of medical device' must be included in the ARTG prior to supply in Australia unless an exemption applies. For example, custom-made medical devices, which are regulated under the Act, are exempt from the requirement to include them in the ARTG.
What makes a kind of medical device?
The criteria for a kind of medical device depend on its classification:
- High risk devices
- For high risk devices (Class III and AIMD, and most Class 4 IVD medical devices), a 'kind of device' is a fairly narrow grouping restricted to a single Unique Product Identifier (UPI), typically covering design variations of a single device such as devices with different length, width, shape, etc. (defined in the MD Regulations as variants).
- Lower risk devices
- For lower classifications, a 'kind of medical device' is a broader concept and covers a range of similar products which have the same sponsor, manufacturer, classification, and are described by the term of the same Global Medical Device Nomenclature (GMDN) code.
- For example, a single ARTG entry may cover a range of different models or brands of similar devices, such as the multiple variations of intravenous infusion sets from the same manufacturer and sponsor.
Please note it is the manufacturer of the device that determines if the device is a medical device and also the class of the device.
So how can we help?
- We can assist you to become a sponsor by sending you the correct forms to use.
- We can work with you and the TGA by you appointing us as your external agent to work with the TGA on your behalf.
- We will give you a complete initial assessment of the TGA requirements prior to initiating any work for you at no charge.
- We will give you feedback and answer questions to ensure that you fully understand the TGA requirements and you financial commitments.
- We will take on board all your data and work on the files to ensure that all data submitted is in line with TGA and New Zealand requirements.
- We will prepare and submit all documentations and applications required by the TGA on your behalf as your ongoing agent.
- Work with you on all audits and documentation required by the regulatory authority.
- We can assist with Class 1, Class 1 s, Class 1M, Class IIa, Class IIb, Class III and IVD applications as well as conformity assessments
- We can prepare current Safety Data Sheets (SDS) that are acceptable in Australia and New Zealand.
- We can also assist with the requirements for Medsafe in New Zealand.
- We will reduce your stress levels of understanding the regulatory requirements and act as your professional advisors.