Ensure that you have optimised your Class I medical device ARTG entries
A medical device must be included in the ARTG before it can be lawfully supplied in or exported from Australia, unless a specific exemption applies (e.g. the device is custom made).
A $530 application fee for Class I medical devices is being introduced from 1 July 2018. This information sheet sets out issues to consider so that sponsors optimise their ARTG listings so that they only pay fees where necessary on the minimum number of entries necessary, while also complying with the therapeutic goods regulatory requirements.
Issues to consider for Class I ARTG entries
In considering whether a product is a medical device requiring a Class I entry in the ARTG, or in reviewing existing ARTG Class I entries, consider the following:
- Is the ARTG entry for a medical device?
Medical devices are products intended by the manufacturer to be used for a therapeutic purpose. If the product is not for use on humans, does not have therapeutic benefits, and does not generally have a physical or mechanical effect on the body or is not used to measure or monitor functions of the body, it may not be a medical device - therefore should not be in the ARTG.
- Are there duplicate ARTG entries?
Medical devices are included in the ARTG as a 'kind of medical device'. For Class I medical devices this means the entry must be for the products with the same sponsor, manufacturer, classification and GMDN code. Where you already have an entry for that 'kind of medical device', you may not be required to create an additional entry and pay a new fee.
- Are the devices appropriately classified?
Medical devices are classified according to the level of harm they may pose to users or patients, with Class I medical devices being the lowest risk. A tool to assist you to verify the classification of a medical device is available on the TGA website at What classification is my medical device?
- Are the devices custom made?
Custom made medical devices are exempt from inclusion in the ARTG. More information on custom made devices is available at Custom made medical devices
- Are the GMDN codes used optimally?
TGA permits the use of GMDN 'template terms' for Class I medical devices, which are broader than the 'preferred terms' required for medical devices in medium-high risk classifications. As GMDN terms used in Australia are determined by the manufacturer, consider discussing the use of template terms with the manufacturer. This should limit the number of entries that you require.
Class I export only ARTG entries
Class I export only entries are also subject to the new Class I application fee. All export only devices - even if they are medium-high risk products that if used in Australia would be classified as Class IIa/b, Class III or AIMD, are classified as Class I (export only).
Export only entries (unlike normal Class I entries) list the individual products supplied under the entry, to facilitate issuing of a Certificate of Free Sale, and enabling overseas regulators to identify which products are covered by the entry. The TGA is upgrading its TBS system to have no limitations to the number of products under each entry.
You can meet with the TGA to discuss how to optimise your entries.
- General assistance is available through the Medical Device Information Unit (contact details below). Assistance can be provided by phone or email.
- You can also book a meeting with a TGA officer to review your organisation's Class I entries by emailing LowRiskDevices@health.gov.au or telephoning the Medical Device Information Unit. These meetings can be provided by telephone or video conference, or may be face to face where available.
To book a face to face session please contact the Medical Device Information Unit by phone or email (details below). Assistance can also be provided by telephone or email.
Need more information?
For further information or assistance from TGA in considering whether you need a Class I ARTG entry, and in reviewing your existing Class I medical device entries, please contact the Medical Device Information Unit on 1800 141 144 (freecall within Australia) or by email at firstname.lastname@example.org.