Step 2 - Things to consider prior to application
Before submitting your application for inclusion you will need to consider the following:
- Does your device require conformity assessment? You will need to view the information about conformity assessment and overseas market authorisation prior to application, to ensure you are submitting the device under the right classification with the right conformity assessment documentation:
- If you are intending to supply a medical device, or IVD medical device, in Australia, you will need to ensure that you meet the definition of a sponsor under the Therapeutic Goods Act 1989. These requirements include that you must be a recognised Australian-based legal entity.
As a first step before you submit an application for inclusion, you will need to establish a relationship with the manufacturer of your device in order to:
- obtain documentation/information required to demonstrate that the kind of medical device complies with the regulatory requirements in Australia;
- provide documentation/information relating to the regulatory, technical, clinical and safety aspects of the device that we may request at any time while you are supplying the device in Australia; and
- advise you of any problems, safety alerts or recalls that may arise with the use of the device.
- 'Kind of Medical Device': Applications for inclusion of medical devices and IVD medical devices, in the ARTG are made for a kind of medical device. This 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.
- In addition to acquiring the appropriate Manufacturer's Evidence prior to making an application, sponsors should also consider having their manufacturer provide them with a Declaration of Conformity in support of their medical device, or IVD medical device, as the TGA may request this documentation at any time. You should review Supporting documentation for inclusion of a device for more information about the documentation you may require throughout the inclusion process.
- Classification of your medical device or IVD medical device: The classification rules are stated in the Therapeutic Goods (Medical Devices) Regulations 2002.The TGA has also produced an online tool to help you determine what classification your medical device is. You can find the tool at What classification is my medical device?
It is important to ensure that your medical device or IVD medical device has been correctly classified by the manufacturer according to Australian classification rules before you make, and pay for, an application for inclusion. Australian classification can be different from other comparable overseas regulator's classification rules and the TGA will not refund your application fee if you submit, and pay for, an application for the incorrect classification for your device.
This tool is for guidance only for medical devices. Currently a classification tool is not available for IVD medical devices.
- Whether your device qualifies for Priority Review designation. If your device is intended for the monitoring, treatment, prevention or diagnosis of a life threatening or seriously debilitating condition; and there is currently an unmet need for your device; and your device represents breakthrough technology or provides a clinical advantage (or public health need for IVD medical devices), you may qualify for Priority Review designation, which will allow your application 'front-of-queue' priority status.
- If your application is selected for audit, you may be asked to provide further documentation. Please review the following for more information: