Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-13A: Essential principle 13A: for implantable and active implantable devices in scope, make a patient implant card (or electronic equivalent) and a patient information leaflet (or electronic equivalent) available, in plain English, with the required identification, use, risk, lifetime and reporting content

What does sch1-13A require?

For implantable and active implantable devices other than excluded small articles (sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips, connectors and similar), export-only devices and devices mostly absorbed within six months that act as fillers, for haemostasis, tissue approximation or fixation, the manufacturer must make available for the patient either an implant card or readily accessible electronic information giving the device name, model and batch, lot or serial number, the manufacturer's name, address and website and, for UDI devices, the UDI device and production identifiers in human- and machine-readable form. A patient information leaflet (or electronic equivalent) must also be available identifying the device and its purpose, explaining safe use and covering: patient group; special operating instructions; intended performance and side effects; residual risks; interaction risks with other equipment and the precautions they call for; examinations, monitoring or maintenance; malfunction symptoms and what to do; expected lifetime and what shortens or lengthens it; end-of-life precautions; when to contact a health professional; materials, substances and manufacturing residuals; and a notice to report serious incidents to the manufacturer and the TGA with the TGA web address. All of it must be in English, readily understood by patients, and legible with characters at least 1 mm on cards and leaflets.