Patient Information Requirements for Implantable Medical Devices in Australia

1. Purpose and Overview

This guidance assists manufacturers and sponsors in complying with legislative requirements for patient information materials under clause 13A of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. These materials include patient information leaflets (PILs) and patient implant cards (PICs), aimed at helping patients understand implanted devices before and after surgery, support informed consent discussions, and facilitate reporting of adverse events. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices Manufacturers create and maintain the content, while sponsors ensure compliance with Essential Principles when devices are included in the Australian Register of Therapeutic Goods (ARTG). Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

2. When Patient Information Materials Are Required

Requirements apply to implantable medical devices and active implantable medical devices (AIMDs), effective from 1 December 2018 with a transition period ending 1 December 2021 for full compliance (both PILs and PICs required). Definitions include devices wholly or partially introduced by surgical intervention remaining in place (or at least 30 days for partial), including those absorbed by the body. Custom-made and patient-matched devices must comply. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices Exemptions cover sutures, staples, dental fillings/braces/crowns, screws/plates/wires/pins/clips/connectors, and devices mostly absorbed within 6 months for filler/haemostasis/tissue approximation/fixation uses. The TGA encourages voluntary provision for exempted devices as best practice. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

3. Responsibilities and Non-Compliance

Sponsors must ensure ARTG-listed devices meet Essential Principles, including patient information requirements. Manufacturers substantiate information with evidence. For non-compliant materials post-1 December 2021, sponsors may apply for consent to import/supply/export via the TGA Business Services portal, requiring an Implementation Plan detailing compliance timelines and interim access measures. Reduced fees ($30 per ARTG entry for PIL/PIC issues only) apply, with retrospective refunds possible for eligible applications from 2021. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

4. Electronic Provision of Patient Information

Amendments effective 29 October 2021 permit electronic formats for PILs and PICs if all required information is included and readily accessible to the patient (e.g., via website). Electronic provision is compliant without consent if accessible early and free. Hard copy remains encouraged for immediate access, but electronic must meet legibility standards and avoid incomplete or promotional content. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

5. Patient Information Leaflets (PILs)

PILs support pre-surgery discussions on device type, condition treated, benefits, risks, alternatives, and post-implant care. Best practice includes plain language, user-friendly design, images/diagrams, sufficient colour contrast, and updates for new risks or data (e.g., specific adverse events for breast implants or urogynaecological meshes). Content must be factual, balanced, and non-promotional to avoid breaching advertising rules. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

6. Patient Implant Cards (PICs)

PICs must include mandatory details: manufacturer name/contact, device name/model, batch/serial/lot number (added at point of care if needed, e.g., via sticker or writing), and unique device identifier if applicable. Physical cards with stickers for device-specific info are compliant. Electronic cards require the same details and accessibility. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

7. Best Practice and Advertising Compliance

Materials should use plain language, be readable (text ≥1 mm high in hard copy), and provide balanced information without comparative claims implying superiority. Avoid promotional elements; refer to the Therapeutic Goods Advertising Code if concerns arise. Non-compliant advertising may trigger TGA follow-up. Patients and professionals can report adverse events via TGA channels. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices

8. Additional Resources

Refer to related TGA pages for legislation, consent applications, advertising guidelines, and adverse event reporting. Attachments detail transition timetables, exemption interpretations, best practice examples, and device-specific adverse events. Source: https://www.tga.gov.au/resources/guidance/providing-patient-information-leaflets-and-implant-cards-medical-devices