Australia: New opportunities for medical device and IVD manufacturers

The Therapeutic Goods Administration (TGA) continues to modernize Australia’s regulatory system, introducing measures that simplify market access for medical devices and in vitro diagnostics (IVDs). Here’s what’s new and how these updates can impact your business.
What’s Changing for Manufacturers?
1. Extended deadlines for IVDs
The TGA has adopted the EU’s IVDR transitional deadlines, allowing manufacturers to align with the new timeframes:
- Class 4 (Class D in the EU): extended to January 1, 2028.
- Class 3 (Class C in the EU): extended to January 1, 2029.
- Class 2 (Class B in the EU): extended to January 1, 2030.
2. More flexibility for Manufacturer Evidence
Manufacturers can now use IVDD Declarations of Conformity (DoC) issued before May 26, 2022, simplifying the registration process. This is particularly helpful for IVDD self-certified devices that may lack ISO 13485 certification.
3. Mandatory audits for high-risk devices
The TGA now requires audits for:
- Class III medical devices certified under MDD or MDSAP.
- Class 3 and 4 IVDs certified under IVDD or MDSAP.
A Step Toward International Harmonization
These updates reflect the TGA’s commitment to aligning Australian regulations with international standards. Leveraging existing certifications like CE Marking or FDA 510(k) makes accessing the Australian market significantly easier for global manufacturers.
The Role of the TGA Sponsor
Registering a medical device or IVD in Australia requires appointing a TGA Sponsor, a local representative who communicates with the Therapeutic Goods Administration (TGA) and ensures compliance with regulations.
For more information on the role of the TGA Sponsor, visit:
👉 TGA Sponsor Service
👉 Or read: Is the TGA Sponsor Responsible for the Quality or Safety of Your Products?
Conclusion
Australia offers significant opportunities for medical device and IVD manufacturers, but navigating regulatory requirements demands the right partner. Contact us to explore how we can help you expand into one of the world’s most dynamic markets.
