Deputy secretary of the federal Health Department Professor John Skerritt told the ABC the Therapeutic Goods Administration's (TGA) plan would ensure patient safety came first. The TGA has issued an infringement notice totalling $13,320 to Melbourne-based company Plus Pak for the alleged unlawful importation of medical face masks in relation to COVID-19. 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SME Assist 'Meeting Your Obligation' workshop - expression of interest, TGA decision: Epidyolex (cannabidiol) is approved as adjunctive therapy for seizures associated with Dravet and Lennox-Gastaut syndrome, Revised content on supplying medicines during a shortage under section 19A, Decisions to be included in the October 2020 Poisons Standard, Australian Public Assessment Report for Fosnetupitant (as chloride hydrochloride)/palonosetron (as hydrochloride), Australian Public Assessment Report for Venetoclax, Public notice of the Delegates' final decisions to amend (or not amend) the current Poisons Standard in relation to melatonin, Public submissions on matters referred to the March 2020 scheduling meetings, and received during the interim consultation period - melatonin, Product defect correction - potential mould contamination, The TGA has issued three infringement notices totalling $39,960 to Sydney-based company Detoxologie Pty Ltd for alleged unlawful advertising, Safety advisory - contains dangerous levels of lead and other heavy metals, The TGA 2019-20 Annual Performance Statistics Report has now been published, We will be initiating targeted compliance reviews of a selection of listed medicines that are at risk of containing safrole, The TGA has made a section 7 declaration to declare that certain sports supplements are therapeutic goods, Australian Public Assessment Report for Adalimumab, Today the TGA announced an interim decision that, if made final, would clarify the regulation of e-cigarettes containing nicotine, and nicotine fluids for vaping, Public submissions on scheduling matters referred to the Joint ACMS-ACCS #25 meetings held in June 2020 - Nicotine, Information about proposed changes to nicotine scheduling and how to make a submission, The TGA is seeking feedback on proposals that aim to enhance Australia’s medical device adverse event reporting system. The TGA action plan announced today incorporates some of the key recommendation from that Senate inquiry. From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices on the ARTG will change. He just said that he could fix it laparoscopically. You can read about the investigation here: "We'd be passing on information about faulty implants in the same way that we'd be passing on information about problems with drugs, or problems with other types of treatments," he said. Many medical devices have a relatively short product lifecycle because they are being continually improved or replaced by newer products. "Recent incidents involving medical devices such as transvaginal mesh highlighted the need to access more complete data and rapidly share information about emerging safety issues to more promptly address threats to patient safety and to take quicker action," he said. This service may include material from Agence France-Presse (AFP), APTN, Reuters, AAP, CNN and the BBC World Service which is copyright and cannot be reproduced. Specialist Reporting Team journalists Sophie Scott and Alison Branley have been covering this issue for several years. "One of the most important things is to increase the level of adverse event reporting," he said. "It's a lengthy process, but it could be a very important process for the safety of men and women who have surgery and require an implanted device.". Australians with medical implants like plates, stents and pelvic mesh could soon have their devices tracked with a barcode system under a new plan health authorities are calling the biggest shake-up in patient safety in 30 years. "Mandatory reporting would give us the true figures of what's going on," she said. Related Story: The Implant Files reveal TGA failures in medical device trial Related Story: As this woman had heart surgery, deadly bacteria entered her body. Other examples include artificial hips, blood pressure monitors, breast implants, catheters, condoms, contact lenses, MRI scanners, syringes and tongue depressors. The new edition of the SUSMP has been registered on the Federal Register of Legislation (FRL) as Poisons Standard October 2020, Reporting adverse events involving medicines, vaccines or medical devices, Report an issue with packaging or storage of a medicine, Help us promote adverse event reporting: promotional resources kit, Early Warning System: consumer questions and answers, Early Warning System: health professional questions and answers, Black Triangle Scheme: Information for sponsors, Database of Adverse Event Notifications (DAEN), Travelling with medicines and medical devices, Buying medicines and medical devices online, Medicinal cannabis: importation and the traveller's exemption, Transvaginal (urogynaecological) surgical mesh hub, MedSearch | Medicine information search app, Medicine shortages: Information for Health Professionals, Accessing medicines during a medicine shortage, Accessing e-cigarettes containing liquid nicotine, Labelling changes: information for health professionals, Registration of medicines for the medical termination of early pregnancy, Prescribing medicines in pregnancy database, Medicine Shortages Information Initiative, Fast track approval pathways for prescription medicines, Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019), Advice about medical devices for health professionals, Regulation of stem cell treatments: information for practitioners, Australian Adverse Drug Reactions Bulletin, Medical device incident reporting & investigation scheme (IRIS) articles, Health professional information & education, Health professional educational materials, Overview of applying for market authorisation, Overview of medical devices and IVD regulation, Useful resources for business and researchers, How therapeutic goods are regulated in Australia, Australian Regulatory Guidelines for Prescription Medicines, Forms for complementary medicine sponsors, Australian Regulatory Guidelines for Biologicals, Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum, Forms for the blood and blood components industry, Disinfectants, sterilants and sanitary products, Scheduling committees meeting dates and decisions timeframes, Report a perceived breach or questionable practices, Advertising basics, general information and enquiries, Consent to import, supply or export goods that do not comply with standards, Cancellation requested by the sponsor - regulatory actions, Failure to pay annual charges - regulatory actions, Information & notices about TGA fees & payments, TGA Business services: getting started with the TGA, TGA Business services - how to use the site, Links to international agencies & organisations, Medicines and Medical Devices Regulation Review, Changing sponsor details in Product Information (PI) and labels of prescription medicines, Restricted representation application checklist, Guidance for submitting an application for approval to use a restricted representation, Prescription medicines: registration of new chemical entities in Australia, Prescription medicines: new or extended uses, or new combinations of registered medicines, Prescription medicines: registration of new generic medicines and biosimilar medicines, COVID-19 delays to adoption of TGO 91 labels, Database of section 19A approvals to import and supply medicines to address medicine shortages, Prescription opioids: Information for health professionals, Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices.