Medical devices reforms: Consumer / patient information materials requirements

Project overview

On 26 October 2017, the Government approved regulations to require patient information materials (patient information leaflets and patient implant cards) to be supplied with implantable and active implantable medical devices in Australia. These regulations have since been amended to allow a more flexible approach to how this information can be provided, including electronic formats.

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.

Since 1 December 2021, manufacturers of all implantable devices in the ARTG (other than those excluded) are required to make patient information materials available. Patient information materials must meet the Essential Principles to be considered compliant. Otherwise, sponsors must apply for consent to import, supply, or export a medical device that does not comply with the Essential Principles.

Further information regarding the graduated transition timeframes is available at Patient implant cards and information leaflets.

Guidance for industry

Guidance on when and how patient information can be supplied, the mandatory data requirements, and best practice (consumer focused language) requirements for patient information materials is available at Medical device patient information leaflets and implant cards.

Consultations

For more information see Consultations and reviews.

Health professional information

Manufacturers of implantable medical devices (other than those excluded) are required to make patient information material available for provision to patients. The provision of these materials may be through health professionals, hospitals or directly from the manufacturer’s Australian representative. The information may be provided in an electronic form (such as downloadable from the manufacturer’s web site) or as a physical document. Health professionals may wish to access patient information leaflets prior to a device being implanted and can use the material to assist a patient’s understanding of the device and the known risks and precautions associated with the particular device. The patient implant card is provided to the patient after the device is implanted. The materials could be made available as an on-demand service, to allow health professionals to access the materials at an appropriate time for their patients.

Further guidance is available at Medical Device Patient Information Leaflets and Implant Cards.

Consumer information

A summary of this project is available at Patient implant cards and information leaflets.