Notifications from Government Bodies Relevant to the IVD Sector
PTA have longstanding relationships with those in department and governmental oversight in roles relevant to how our products enter the Australian market.
The PTA Technical and Regulatory Standing Committee also convene regularly to monitor and manage the ever-changing landscape of regulation, quality control, and imports.
Check back regularly for relevant updates, check in with your regulatory TARSC member, or connect directly with the relevant departments.
Mar 31st 2025: TGA response to delays in Class 3 listings of “same kind” devices
PTA met with the TGA again today to review initiatives to address the delays and improve the process.
Additions to an existing kind of class 3 laboratory device (that has certification from a comparable regulator) will be via a spreadsheet, emailed to the TGA.
The standardised spreadsheet is being finalised between PTA and the TGA and will be released within the next week, along with revised guidance.
Members will be permitted to supply such devices within 20 working days of emailing their spreadsheet to the TGA. There will be no further requirements from sponsors of the application and TGA will use post market processes to follow up, if needed.
Feb 11th 2025: FMD in Germany
BICON is issuing a field notice to the Border Force team informing kitted and packaged IVDs are exempt from the FMD embargo, effective immediately. PTA worked closely with the BICON team to have this exemption put in place.
For any products that contain animal fluids or cells it is recommended that declarations contain country of origin and date of collection of the animal fluid and date of collection.
Contact your regulatory team, the BICON website for more details and reach out to PTA CEO if you are still experiencing issues related to this matter.
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