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TGA to Accept FDA 510(k)

Australian Regulation Update: TGA to Accept FDA 510(k) Clearances for Class III Medical Devices


In a significant development for the medical technology sector, the Therapeutic Goods Administration (TGA) has introduced an amendment to Australian legislation, effective 19 October 2024. This change enables sponsors to submit applications for Class III medical devices on the Australian Register of Therapeutic Goods (ARTG) using US FDA 510(k) clearances. Previously, only premarket approvals (PMA) were accepted as supporting evidence from the US.

The amendment registered on 18 October 2024 (Therapeutic Goods—Medical Devices Information Amendment Determination No. 2, 2024), spearheaded by Tracey Duffy from the Department of Health and Aged Care, brings a new layer of flexibility to the ARTG process for Class III medical devices, TGA to Accept FDA 510(k).


Key Points of the Update:

  1. Class III Medical Devices: ARTG applications for these devices can now be supported by FDA 510(k) clearances alongside an MDSAP QMS certificate. This expands the acceptance criteria, which were previously limited to US PMA approvals.

  2. Class IIa Devices: Devices exempt from 510(k) requirements in the US can now rely solely on MDSAP QMS certification for ARTG applications. This marks a departure from the earlier regulation that required 510(k) clearances for Class IIa devices when using US FDA evidence.


A Mandatory Application Audit for the TGA to Accept FDA 510(k)

While this update opens doors for faster approvals, there are additional steps. Devices supported by 510(k) clearances (unlike those with PMA approvals) must undergo a mandatory TGA application audit before being included in the ARTG. This adds an essential layer of safety and compliance oversight. However, the good news it´s that the TGA to Accept FDA 510(k).


The introduction of these provisions is a positive shift for companies looking to expand into the Australian market. It aligns Australia’s regulations more closely with global standards, potentially speeding up market access for high-quality medical devices that already have approval in the US.

This regulation update simplifies the process for international medical device manufacturers, reducing hurdles and fostering innovation within the industry. Whether your product falls under Class III or IIa, these changes may allow you to bring it to market in Australia more efficiently than before. Stay compliant by ensuring all ARTG applications are paired with the required documentation, and consult with your regulatory partner to navigate the audit requirements effectively.



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