From 1 December 2021 all implantable and Active Implantable Medical Devices (AIMD) are required to have patient information materials available in the form of both Patient Information Leaflets (PILs) and Patient Implant Cards (PICs), unless specifically excluded from these requirements. PILs and PICs must meet the Essential Principles to be considered compliant.
Sponsors who will not have compliant patient information materials in place by 1 December 2021 will need to apply for consent to import, supply, or export a medical device that does not comply with the Essential Principles to ensure continuous supply of an affected device. This includes payment of application fees and the approval from the delegate of the Secretary. The application form is available on the TGA Business Services (TBS) portal. More information is available on the Essential Principles - consent for non-compliance web page.
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.
Contents
- About this guidance
- Patient information materials
- Purpose
- Manufacturer and sponsor responsibilities
- When patient information materials are required
- Patient information materials that are non-compliant with the Essential Principles
- Compliance with advertising legislation
- Patient information leaflets
- Purpose
- Mandatory requirements for leaflets
- How and when to provide leaflets
- Electronic leaflets
- Leaflets for a ‘kind of device’
- Date stamping and version control
- Patient implant cards
- Purpose
- Mandatory requirements for implant cards
- How to provide implant cards
- Review by the TGA
- Reporting adverse events
- Glossary
- Attachment 1: Timetable for transition
- Attachment 2: Implantable medical devices excluded from requirements
- Sutures
- Staples
- Dental fillings
- Dental braces
- Tooth crowns
- Screws
- Wedges
- Plates
- Wires
- Pins
- Clips
- Connectors
- Similar articles
- Attachment 3: Best practice for patient information leaflets and patient implant cards
- General design principles
- Attachment 4: Breast Implants – specific information to be included about adverse events
- Attachment 5: Urogynaecological meshes - specific information to be included about adverse events