Transition timeframe

From 1 December 2018 manufacturers of all new permanently implantable devices (other than those exempted) will need to provide patient implant cards and have a patient information leaflet in the TGA approved format.

A graduated transition period applies for existing medical devices, reflecting public health imperatives. The following table summarises transition arrangements:

Required patient information

Patient implant cards and patient information leaflets are required for a medical device that is:

• an implantable medical device or an active implantable medical device; and
• not a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip or connector.

Information on the card and leaflet must be included in English (but may also be in other languages). The information may also include diagrams or drawings. Any number, letter, symbol, or letter or number in a symbol, used in a patient implant card or patient information leaflet must be legible and at least 1 millimetre high.

Patient implant cards for implantable devices

A patient implant card that meets the following requirements must be provided with the medical device:

• name of the device; and
• model of the device; and
• batch code, lot number or serial number of the device; and
• unique device identifier of the device (if any)
• manufacturer’s name, address and website

Patient information leaflets for implantable devices

A patient information leaflet that meets the following requirements must be provided with the medical device:

The leaflet must include the following information:

• information identifying the device, or the kind of device;
• the intended purpose of the device;
• information explaining how to use the device safely;
• other information about the device that the manufacture considers would be useful for patients.

In particular, the leaflet must include:

• the name and model of the device
• the intended purpose of the device and the kind of patient on whom the device is intended to be used
• any special operating instructions for the use of the device
• the intended performance of the device and any undesirable side effects that could be caused by use of the device
• any residual risks that could arise due to any shortcomings of the protection measures adopted
• warnings about risks that could arise from the interaction of the device with other equipment (eg risk of electrical interference from electro-surgical devices, or magnetic field interference from magnetic resonance imaging devices), and precautions and other measures that, because of those risks, should be taken by the patient or a health professional
• the nature and frequency of regular or preventative examination, monitoring or maintenance of the device that should be undertaken; symptoms that could indicate that the device is malfunctioning; precautions and other measures that should be taken by the patient if the performance of the device changes or the patient experiences any of the symptoms
• the expected device lifetime; anything that could shorten or lengthen the device lifetime; precautions and other measures that should be taken at, or near, the end of the expected device lifetime
• other circumstances in which the patient should contact a health professional in relation to the operation of the device
• the materials and substances included in the device, and any manufacturing residuals that could pose a risk to the patient
• a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and the address of the Therapeutic Goods Administration's website

The information in the leaflet must be written in a way that is readily understood by patients.

Regulatory amendments available in full: Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017