Australian regulator closes in on Class I devices
In 2014, the Australian Government announced the Expert Panel Review of Medicines and Medical Devices Regulation, which was tasked to assess and provide feedback on the regulatory framework for medicines and medical devices in Australia, and furthermore, provide recommendations on the approach to achieve long-term sustainable reform to the regulation in Australia.
In total, 58 recommendations were put forward, including Recommendation Twenty-Three: The Panel recommends that the Australian Government undertake a review of the range of products currently classified as Class I medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions.
As a result of the recommendation, the Therapeutic Goods Administration (TGA) has been carrying out reviews of the regulation of ‘low risk’ products, including products entered on the ARTG as Class I medical devices. More specifically, the regulator has been investigating specific groups, or products identified by particular GMDN codes to determine their legitimacy in being included in the Australian Register of Therapeutic Goods (ARTG). This is done by specifically reaching out to Sponsors of Class I medical devices, and asking for specific information, including product labelling etc.
The regulator is asking sponsors of Class I medical devices, to check that the medical device is correctly included in the ARTG. If you as the sponsor identify that your product is incorrectly included, you should request cancellation of the ARTG entry. Be sure to check accurately, as what is not outlined here (which may catch some out), is that cancellation will result in the sponsor no longer being able to supply the product to the market, effective immediately on cancellation. It is imperative that the Sponsor works closely with the manufacturer to ensure they understand how the manufacturer classified the device, and that any cancellation is communicated prior to executing. This could save an uncomfortable discussion with both the regulator and the manufacturer.
The local Sponsor should also fully understand the implications of the cancellation from a commercial aspect. Generally, in Australian tenders, part of the requirement is that the product is covered by an existing ARTG. It’s imperative that it’s understood how this would affect the continued supply prior to cancelling the entry.
You can obtain additional information on the recently published article on the regulator’s website around the definition of a medical device (https://www.tga.gov.au/how-determine-if-your-product-should-be-included-artg). In addition, you can also get help with classifying your device under the SME Assist portal (https://www.tga.gov.au/sme-assist).
If you’re unsure that the classification of your device is accurate, be sure to reach out to us for a no-obligation discussion before you decide to cancel your entry on the ARTG.
Looking to fly south for warmer weather? We have the skills in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us to discuss your needs and how we can help. Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)