Australia's Therapeutic Goods Administration has proposed the reclassification of surgical meshes from class IIb to class III and a requirement that consumers be given patient implant cards and product information by manufacturers of implantable devices and long-term surgically invasive implants. The proposals, which come as part of an effort to align Australia's rules with the new Medical Device Regulation in Europe, are open for comments until Aug. 25.
Australia seeks feedback on proposed medtech regulations
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