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Implantable Devices

Overview​

Implantable medical devices are devices intended to be totally or partially introduced into the human body and to remain there after a procedure. They carry higher regulatory requirements than comparable non-implantable devices due to the invasive nature of implantation, difficulty of removal, and the long-term patient safety implications. Implantable devices span multiple classification levels — from Class IIa (short-term implants) through Class IIb and Class III (long-term implants in contact with critical anatomical structures).

Classification of Implantable Devices​

Implantable devices are classified based on invasiveness, duration, and anatomical location:

  • Class IIa — short-term surgical implants (intended for use less than 30 days, not in contact with heart, CNS, or central circulatory system)
  • Class IIb — long-term implants not in contact with heart, CNS, or central circulatory system; includes most orthopaedic implants (hip, knee, shoulder), breast implants, spinal implants not in contact with CNS
  • Class III — long-term implants in contact with the heart, central circulatory system, or central nervous system; includes coronary stents, heart valves, deep brain stimulators

Patient Implant Cards​

From 1 November 2024, manufacturers and sponsors of implantable devices are required to provide patient implant cards with their devices. Patient implant cards contain essential information about the implant that patients must have for their own medical management, including:

  • Device name and description
  • Manufacturer details
  • ARTG entry number
  • UDI (where applicable)
  • Relevant warnings or precautions for the patient

Sponsors are responsible for ensuring patient implant cards are provided and that healthcare facilities give them to patients at the time of implantation.

👉 Patient implant card requirements — TGA

Post-Market Annual Reporting​

Certain implantable device classes are subject to mandatory annual reporting obligations:

  • Class III devices — 3 years of annual reporting after ARTG inclusion
  • Class AIMD (now Class III) — same
  • Class IIb implantable devices — check current TGA requirements

Annual reports must include post-market surveillance data and confirm continued compliance with conditions of inclusion.

Unique Device Identification (UDI)​

UDI requirements apply progressively to medical devices, with implantable devices in higher-risk classes among the first to be required to comply. UDI enables tracking of implants through the supply chain and facilitates effective recalls.

👉 UDI requirements — TGA

Official Sources​