Australia TGA Publishes Latest Guidance on Medical Device Patient Information Leaflets and Implant Cards

The Therapeutic Goods Administration (TGA) Australia has published the latest version of the guidance document on patient information materials (patient implant cards and patient information leaflets) in March 2022. 

One notable update is regarding medical devices that are intended to be wholly or mostly absorbed by a patient’s body within 6 months of being implanted, as well as being used as a filler, haemostasis, tissue approximation and fixation of other medical devices within tissue. This update under attachment 2 discusses about the implantable medical devices that are exempted from providing patient information materials. 

Some examples are synthetic bone grafts and bone fillers, for use as fillers. For haemostasis, the medical devices exempted are absorbable collagen-based materials, haemostatic matrices, and bone wax. And for tissue approximation, some examples are tissue adhesives and absorbable tape for wound closure. 

More details can be found in “Medical device patient information leaflets and implant cards, March 2022”:  

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