Manufacturers of implantable devices are required to update patient implant cards to include both UDI-DI and UDI-PI in a machine-readable format (barcode) and human-readable format.
This regulatory change is vital for enhancing the accuracy and efficiency of device tracking and adverse event reporting. It ensures healthcare professionals and patients can easily access accurate information about their implants, which facilitates better safety monitoring and response.
Ensure all patient implant cards are updated to include full UDI information in the mandated formats by the specified timeline to comply with TGA regulations.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Requires inclusion of full UDI (DI and PI) on patient implant cards in machine-readable (barcode/AIDC) and human-readable formats for applicable devices. Clarifies the role of PICs and PILs in supporting adverse event reporting and safety updates. Updates instructions for patients on using My Health Record (MHR) to store implant details.
Manufacturers of implantable devices must update their patient implant cards to include machine-readable UDI data. This change is designed to improve the accuracy and speed of device tracking and adverse event reporting by healthcare professionals and patients.
Ensure all patient implant cards are updated to include full UDI information in the mandated formats by the specified timeline to comply with TGA regulations.
The Therapeutic Goods Administration (TGA) has revised its guidance on patient implant cards (PICs) and patient information leaflets (PILs). Manufacturers must now ensure PICs for devices subject to Unique Device Identification (UDI) requirements include both UDI-DI and UDI-PI in machine-readable formats, such as barcodes, alongside human-readable text. This update also clarifies the role of PICs and PILs in supporting adverse event reporting and outlines updated instructions for using My Health Record (MHR) to record implant details.
What changed: Manufacturers of implantable devices are required to update patient implant cards to include both UDI-DI and UDI-PI in a machine-readable format (barcode) and human-readable format.
Why it matters: This regulatory change is vital for enhancing the accuracy and efficiency of device tracking and adverse event reporting. It ensures healthcare professionals and patients can easily access accurate information about their implants, which facilitates better safety monitoring and response.
Practical implication: Ensure all patient implant cards are updated to include full UDI information in the mandated formats by the specified timeline to comply with TGA regulations.
Published from the Firecrawl policy change extraction pipeline.
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