Patient information material for implantable medical devices

It is mandatory for implantable and active implants to have patient information materials.

Excluded from this are devices intended to be absorbed within 6 months, sutures, staples, dental fillings, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar.

Information on the card and leaflet must be in English (but may also be in other languages).

The information can include diagrams or drawings.

Any number, letter, symbol, or letter or number in a symbol, used must be legible and at least 1 millimetre high.

Patient implant cards

A patient implant card must include:

• the device name
• model of the device
• batch code, lot number or serial number of the device
• manufacturer's name, address, and website.

Patient information leaflets

A patient information leaflet must include:

• information identifying the device, or the kind of device
• the intended purpose of the device
• information explaining how to use the device
• other information the manufacturer considers would be useful for patients, and
• notice that serious incidents should be reported to the manufacturer and TGA.

The leaflet must be easy to read and understand.

Non-compliance

These requirements came into effect December 2021.

The import, supply or export of devices that don't meet Essential Principles is illegal.