Update on Surgical mesh medical devices
From December 1st 2018, the TGA will strengthen their premarket assessment of surgical mesh medical devices by reclassifying all these devices from Class IIb to Class III.
This reclassification will be subject to transitional provisions that will allow manufacturers and importers to continue supplying their surgical mesh devices to Australia during the reclassification period. Take note of the key dates below to ensure there is no disruption in the supply of your products to Australia:
- From 1st December – review all your existing ARTG entries and premarket applications for devices that qualify as a “surgical mesh medical device”
- By 1st May 2019 (or within two (2) months of the start date of your ARTG entry) – notify TGA of all surgical meshes included on the ARTG as Class IIb
- By 1st December 2020 – submit a Class III application for any urogynaecological mesh that you want to continue supply in Australia
- By 1st December 2021 – Submit a Class III application for any other type of surgical mesh.
By transitioning to a Class III Medical Device, importers and manufacturers must consider the followings:
- The Class III application of surgical mesh medical devices (new and current devices entered under Class IIb in the ARTG) will be subject to the Class III TGA application fee and compulsory audit assessment fee
- Class III devices attract more stringent premarket review requirements and manufacturers must designate a Unique Product Identifier (UPI) for their device. Current Class IIb surgical meshes that are covered by the same ARTG entry would only be eligible for a common Class III ARTG entry if viewed as the same Class III kind of medical device – bearing the same UPI. Devices with multiple product identifiers will no longer be eligible for a single entry
- Discuss the timing of your EU approvals under the new MDR with your Notified body if you intend to use EU evidence issued from a Notified body in your TGA conformity assessment application
These regulatory amendments were first announced by the TGA in October 2017, in response to Australian public health imperatives. By formalizing its transitional provisions, TGA takes a step ahead of Europe who is implementing similar initiatives. TGA has published today specific guidance on the regulation of surgical meshes. If you import and/or supply surgical mesh devices to Europe and Australia, you need to know about regulatory changes affecting your products and make sure you have plans in place to meet the changed requirements.
If you’re only just hearing about this or would like to discuss these new requirements with one of our team members, be sure to contact us for a free, no obligation discussion. Email [email protected] or call us:
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