Author: Jenny Lin/ Manager, Medical Devices / IVD, Australia
On 23 July 2021, the Australia government took the industry by surprise in repealing Clause 4.1 and amending Clause 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (“the regulations”) in relation to the TGA conformity assessment and mandatory TGA application audit respectively.
This article provides a snapshot of the legislative updates and how these changes may impact your ARTG processes in Australia.
TGA now accepts EC certificates issued under MDR or MDD in lieu of direct TGA conformity assessment:
Under Clause 4.1 of the Regulations, devices containing medicines or materials of animal, microbial, recombinant or human origin and Class 4 IVDs are subject to direct TGA conformity assessment (CA) regardless of the status of overseas approvals.
The repeal of this clause therefore now allows manufacturers of the above-mentioned devices to leverage EC certificates issued by their notified body under EU regulations, including certificates from:
- Medical Devices Regulation (2017/745)
- In Vitro Diagnostics Regulation (2017/746)
- 93/42/EC (Medical devices)
- 90/385/EEC (Active implantable medical devices)
- 98/79/EC (In vitro diagnostic medical devices)
A direct TGA conformity assessment often takes more than 12 to18 months to complete (potentially longer depending on the quality of data submitted to TGA. Being also one of the more costly assessments, this change will no doubt significantly reduce regulatory burden in Australia and ensure more harmonized processes are used for market entry.
However, before you abandon the TGA conformity assessment pathway, there are a few factors to consider:
- EC certification can only be used if the product classification in the EU is the same as the TGA classification. A number of products attract different classifications in the regions, especially for devices that were certified under the old EU MDD. For example, the EU Directives will not necessarily classify devices containing microbial, substances as Class III, where this was the case in Australia for many years.
- Timing – You may consider continuing or withdrawing your current TGA CA application depending on how far you are into the application process and when your product is anticipated to obtain MDR/MDD certification. Bear in mind that there is currently no provision in the legislation for TGA to refund applications made prior to 28 July 2021 (although TGA has commenced considerations to allow refunds). Additionally, depending on the progress of your TGA Conformity Assessment application, it may be more efficient to stick with your current application, rather than withdrawing and applying for a new Class III ARTG entry application.
- The TGA has expressed their intention to expand level 2 audits for devices that contain medicines or materials of animal, microbial, recombinant, or human origin and Class 4 IVDs which are supported by EC certification. This expanded assessment may include reviews of Engineering, Biomaterials, Sterility or Quality Management System elements which must be considered from the perspective of the TGA.
Class III, AIMD and Class 4 IVDs are no longer subject to mandatory TGA audits if certified under 2017/745 MDR:
Specific high-risk devices are subject to TGA mandatory level 2 audit under Clause 5.3(1) of the Regulations. These include Class III, active implantable devices (AIMD) and Class 4 IVDs.
The addition of Clause 5.3 (2AA) has provided an exemption for these devices from TGA mandatory audits if the device has been approved under the new MDR. This also means that there will be no application audit fees to be paid for an ARTG application supported by an MDR EC certificate. Keep in mind however, that whilst mandatory audits are no longer required, the TGA can still “select” any application for audit at any time!
Further interpretation on these regulatory changes have been published by the TGA to provide insights on practical implementation.
These recent changes represent a huge step towards harmonization of regulatory systems across the globe, with the potential for significant efficiency gains and cost reductions for industry. Make sure you consider these changes in your regulatory strategy and reach out if you need support!