On 29 October 2021, amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect allowing greater flexibility in how patient information materials can be supplied with implantable and active implantable medical devices in Australia. The guidance below includes those amendments.
On 26 October 2017, the Government approved regulations to require patient information materials to be supplied with implantable and active implantable medical devices in Australia.
Since 1 December 2018, manufacturers of all new permanently implantable or active implantable medical devices (other than those excluded) have been required to make patient information leaflets available to patients with the device.
A graduated transition period applied for existing medical devices, reflecting public health imperatives. From 1 December 2021 all implantable medical devices are required to have patient implant cards and information leaflets.
Required patient information
Patient implant cards (PICs) and patient information leaflets (PILs) 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, connector or similar article.
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.
Guidance for manufacturers and sponsors is available, which outlines the legislative requirements for patient information materials (patient implant cards and patient information leaflets).
Patient implant cards for implantable devices
A patient implant card that meets the following requirements must be provided to the patient:
- name of the device; and
- model of the device; and
- batch code, lot number or serial number of the device; and
- manufacturer's name, address and website
Patient information leaflets for implantable devices
A patient information leaflet that meets the following requirements must be provided to the patient:
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 manufacturer considers would be useful for patients; and
- 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.
More detailed information on the legislated requirements for the leaflet must include can be found on the consumer information web page.
Non-compliant patient information materials
Some manufacturers of medical devices have advised the TGA that they may not have a PIC or PIL that is completely compliant with the legislative requirements in place by 1 December 2021. As such, the TGA will consider their proposed interim arrangements to ensure that the information materials can still be provided to patients or healthcare practitioners in an acceptable format. To ensure continuous supply of an affected device, an application for consent to supply non-compliant patient information materials will need to be in place prior to 1 December 2021.
Note:
Implantable medical devices must have compliant patient information materials or an approved consent to import, supply, or export a medical device that does not comply with the Essential Principles, in place before 1 December 2021 to ensure supply of the medical device from 1 December 2021.