You are here

Medical device patient information leaflets and implant cards

4 January 2021
Download Medical device patient information leaflets and implant cards

Description

This guidance provides an overview of:

  • the different types of patient information materials (patient information leaflets and patient implant cards);
  • when patient information must be supplied;
  • how to meet the mandatory requirements for patient information; and
  • best practice requirements for patient information.
  • About this guidance
  • Patient information materials
  • Patient information leaflets
  • Patient implant cards
  • Review by the TGA
  • Reporting adverse events
  • Glossary
  • Attachment 1: Timetable for transition
  • Attachment 2: Implantable medical devices excluded from requirements
  • Attachment 3: Best practice for patient information leaflets and patient information cards
  • Attachment 4: Breast Implants – specific information to be included about adverse events
  • Attachment 5: Urogynaecological meshes – specific information to be included about adverse events

We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.