In a surprising turn, the Therapeutic Goods Administration (TGA), Australian regulator of therapeutic goods, has announced the introduction of an application fee for Class I devices.
Until now, class I devices entered into the register in Australia have had no application fee, but did have an annual license fee. This has likely permitted some products that would normally fall outside the definition of a medical device to be included in the register without any considerable financial impact to the Sponsor. As described in the TGA Information Sheet, a medical device is a product 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.
The introduction will hopefully encourage manufacturers and sponsors to consider appropriately classifying their device before making a submission on the register. Furthermore, one can anticipate that introduced fees will likely cover the costs of additional reviews in an effort to further clean up the Australian Register of Therapeutic Goods (ARTG).
In addition, as there is currently no review conducted of Class I devices, there is a chance that some may have taken the opportunity to get a product on the market with an incorrect classification. As you would imagine, an inability to justify an incorrectly classified medical device can lead to an uncomfortable discussion with the regulator, including Post Market and legal outcomes.
None of this should come as a surprise considering it was outlined within the TGA response to the Medicines and Medical Devices Review (MMDR) where there was a proposal to undertake a review of products currently classified as Class I. What is surprising, is the speed in which the new fees have been introduced. With this introduction, both Manufacturers/Sponsors should consider an internal review of their existing products to ensure that the devices in question are appropriately classified, and more importantly, have the necessary documentation in place to support the entry on the ARTG.
If you’d like more information on this, or what you should be doing to plan for this, contact us to set up a no-obligation conversation and discuss how you can be prepared.
If you’re currently working through your CFDA applications for either IVD’s or Medical Devices, or are considering the China market for your product, please reach out to us for a free, no obligation discussion on how we may support you.