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Consultation: Proposed refinements to the requirements for medical device patient information materials
This consultation closed on 1 September 2021.
It is important that patients have access to information about their implanted medical devices.
In Australia, in late 2017, the Government approved regulations that require patient information materials to be supplied with implantable and active implantable medical devices. In 2018, following consultation with health professionals, consumer groups, consumers and the medical device industry, guidance was published on the TGA website setting out detailed requirements for patient information materials.
In 2020, revised guidance was published Guidance document for PICs and PILs, taking into account lessons learnt from two years of implementation, as well as consumer and sponsor feedback to include:
- further clarification on the content and form of patient information leaflets (PIL) and patient implant cards (PIC); and
- devices that are exempt from the requirements to provide PIC and PIL.
This consultation raised questions around the provision of materials and when patient implant cards should be required and is published on the Department of Health consultation hub.