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Medical device patient information leaflets and implant cards
Requirements for new and on-market implantable medical devices
About this guidance
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.
This guidance refers to requirements set out in clause 13A of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).
Our Acronyms and glossary page may be useful to clarify the terms used in this document.
Purpose of this guidance
The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets the legislative requirements for patient information materials (patient implant cards and patient information leaflets) and thus understand how they can comply with the legislative requirements.
This is a guide only; manufacturers and sponsors should familiarise themselves with the legislative and regulatory requirements and, if necessary, seek professional advice.
It is the responsibility of sponsors and manufacturers to understand and comply with these requirements.
This guidance will continue to be reviewed and revised, where necessary.