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Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems

Guidance on the transitional arrangements and obligations
22 September 2021
Download Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems

Description

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

  • About this guidance
  • Background
  • Requirements for reclassification
  • Medical devices in direct contact with the heart, CCS or CNS
  • Examples of devices to be reclassified to Class III
  • What you need to do
  • Medical devices included in the ARTG prior to 25 November 2021
  • Applications to include a medical device in the ARTG lodged before 25 November 2021
  • Cancelling your ARTG inclusion
  • Applications to include a new medical device on or after 25 November 2021
  • Notifying the TGA
  • Class III applications for ARTG inclusion
  • Kind of device: Class IIa vs Class III
  • What to include in your application
  • Fees
  • If your inclusion application is not successful
  • When to cease supply using your old ARTG entry

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