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Following a decision by the European Commission to implement a number of medical device reforms, including to up-classify all surgical mesh medical devices to Class III and to provide patient implant cards and consumer product information for all implantable medical devices.
Pharmaceutical company Novo Nordisk A/S, in consultation with the TGA, has initiated a consumer level recall of some batches of their NovoPen Echo insulin cartridge holder after detecting there is a possibility they may crack or break if exposed to chemicals in certain cleaning agents.
Australia’s medicine and medical devices regulator, the TGA, has decided to remove a number of mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG).