Oct 4, 2021

The Australian Therapeutic Goods Administration (TGA) has issued new guidance on plans to reclassify medical devices involved in circulatory and nervous systems from Class IIa (moderate risk) to Class III (high risk).

According to the TGA guidance, the following devices will be reclassified to Class III beginning November 25, 2021:

  • Devices in direct contact with the heart and central circulatory system (CCS), and intended for short-term or transient use
  • Devices in direct contact with the central nervous system (CNS), and intended for transient use

The TGA guidance identifies several examples of devices affected by the reclassification. Up-classified devices with CCS applications will include cardiac vent catheters, central venous catheterization kits and cardiopulmonary cannulae.

Affected devices targeting the CNS include flexible fiberoptic neuroscopes, rigid neuroscopes and spinal needles.   

Class III classification requirements for Australian market applicants

For affected Australian medical device market registrants, meeting TGA registration requirements as Class III device sponsors entails providing more detailed assessments of both manufacturers’ quality management systems and technical documentation for these devices.

In addition, market applicants must provide conformity assessment documentation that demonstrates processes and procedures in line with Class III classification requirements. Affected applicants will also be subject to mandatory audit assessments by TGA regarding device inclusion applications.

TGA timeframes for reclassification compliance

Although the TGA’s up-classification change takes effect in late November 2021, compliance deadlines for sponsors of impacted devices will depend on the current status of their registrations.

  • For devices included in the Australian Register of Therapeutic Goods (ARTG) before November 25, 2021, sponsors must notify the TGA before May 25, 2022 that their listings will need to be reclassified. These sponsors should also submit applications for listing their devices as Class III in the ARTG before November 1, 2024.
  • Sponsors that have submitted applications for inclusion in the ARTG for Class IIa devices before November 25, 2021 should notify the TGA that their listings will need to be reclassified to Class III either before May 25, 2022 or within two months of the start dates of their ARTG entries—whichever is the later date. Finally, these sponsors should submit applications for ARTG listings as Class III devices before November 1, 2024.
  • Sponsors that have not submitted applications for listing devices in the ARTG before November 25, 2021 should submit their applications for new Class III devices.

Device sponsors and manufacturers affected by the TGA reclassification plan should refer to the guidance for additional requirements.

Learn more about Australia TGA medical device regulatory requirements at Emergo by UL:

 

Author

  • Stewart Eisenhart

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