{"product_id":"a-critical-review-of-australias-regulatory-oversight-for-new-generation-personalised-medical-devices","title":"A Critical Review of Australia’s Regulatory Oversight For New Generation Personalised Medical Devices","description":"\u003cp data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eTitle:\u003c\/strong\u003e\n\u003cspan\u003e\u003c\/span\u003eA Critical Review of Australia’s Regulatory Oversight For New Generation Personalised Medical Devices \u003cbr data-mce-fragment=\"1\"\u003e\n\n\u003cstrong data-mce-fragment=\"1\"\u003eSubject Classification: \u003c\/strong\u003e\n\u003cspan data-mce-fragment=\"1\"\u003e\n\u003cspan\u003eHealthcare, Law and Legal Ethics, Medicine and Medical Ethics\u003c\/span\u003e\n\u003cstrong\u003e \u003c\/strong\u003e\n\u003c\/span\u003e\n\u003cbr data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eBIC Classification: \u003c\/strong\u003eMBP, LA \u003cbr data-mce-fragment=\"1\"\u003e\n\u003cmeta charset=\"UTF-8\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eBISAC Classification: \u003cspan\u003e\u003c\/span\u003e\n\u003c\/strong\u003e\n\u003cspan data-mce-fragment=\"1\"\u003e\n\u003cspan\u003eLAW046000, MED003040, TEC059000\u003c\/span\u003e\n\u003c\/span\u003e\n\u003cbr data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eBinding:\u003c\/strong\u003e\n\u003cspan data-mce-fragment=\"1\"\u003e Hardback, Paperback, eBook\u003c\/span\u003e\n\u003cbr data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003ePublication date:\u003c\/strong\u003e\n\u003cspan data-mce-fragment=\"1\"\u003e 15 Sep 2024\u003c\/span\u003e\n\u003cbr data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eISBN (Hardback):\u003c\/strong\u003e\n\u003cspan\u003e\u003c\/span\u003e978-1-80441-728-7 \u003cbr data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eISBN (eBook):\u003c\/strong\u003e\n\u003cspan\u003e\u003c\/span\u003e978-1-80441-729-4 \u003cbr data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003eISBN (Paperback): \u003c\/strong\u003e\u003cspan\u003e\u003c\/span\u003e978-1-80441-730-0\u003c\/p\u003e\n\u003cp data-mce-fragment=\"1\"\u003e \u003c\/p\u003e\u003cp data-mce-fragment=\"1\"\u003e\u003cmeta charset=\"utf-8\"\u003e\u003cspan\u003eTo view a sample of the book, please click \u003c\/span\u003e\u003cspan style=\"text-decoration:\" underline data-mce-style=\"text-decoration:\"\u003e\u003cstrong\u003ehere\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp data-mce-fragment=\"1\"\u003e \u003c\/p\u003e\n\u003cp data-mce-fragment=\"1\"\u003ee-books available for libraries from \u003cspan\u003e \u003c\/span\u003e\n\n\u003cstrong data-mce-fragment=\"1\"\u003eProquest\u003c\/strong\u003e\n\n\u003cspan\u003e \u003c\/span\u003eand \u003cspan\u003e \u003c\/span\u003e\n\n\u003cstrong data-mce-fragment=\"1\"\u003eEBSCO\u003c\/strong\u003e\n \n\u003cmeta charset=\"utf-8\"\u003e\n\u003cspan data-mce-fragment=\"1\"\u003ewith non-institutional availability from \u003c\/span\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003e\nGooglePlay\n\u003c\/strong\u003e\n\u003c\/p\u003e\n\u003cp data-mce-fragment=\"1\"\u003eFor larger orders, or orders where you require an invoice, contact us  \u003cspan id=\"cloak8074a48c555b85c31ec4347354a45e96\" data-mce-fragment=\"1\"\u003e\nadmin@ethicspress.com\n\u003c\/span\u003e\n\u003c\/p\u003e\n\u003ch5\u003eDescription\u003c\/h5\u003e\n\u003cp class=\"MsoNormal\"\u003e\n\u003cspan\u003eAustralia's medical device regulator Therapeutic Goods Administration (TGA) generally uses the term personalised medical device to describe medical devices made available to address specific individual requirements. 2019 Regulatory amendments including new definitions for personalised medical devices involved the subdivision of personalised medical devices into three categories of custom-made medical devices, patient-matched medical devices and adaptable medical devices, and the adaptation of the International Medical Device Regulatory Forum's (IMDRF’s) definitions for personalised medical devices.\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"MsoNormal\"\u003eThis book highlights inadequacies and oversights in the current regulatory regime, and explores possible solutions to address them. The study focuses on the regulatory control of personalised medical devices in Australia, but elements of the proposed regime are also compared with similar elements within the United States and South Korean medical device regulatory frameworks. \u003c\/p\u003e\u003cp class=\"MsoNormal\"\u003eThe book also explores some technically complex medical and legal principles and issues that arise and interact with each other in the application of personalised medical devices. It concludes with specific observations and recommendations aimed at improving the current Australian regulatory framework for new-generation personalised medical devices. \u003c\/p\u003e\u003cp class=\"MsoNormal\"\u003eThis study also examines the benefits and drawbacks of the IMDRF-led regulatory reforms in various international jurisdictions. The IMDRF is spearheading medical device international regulatory alignment; therefore, the scope and significance of the information discussed is important in international jurisdictions. \u003c\/p\u003e\u003cp class=\"MsoNormal\"\u003eThis detailed study is a key reference work for academic researchers, medical device manufacturers and sponsors, and legal and regulatory experts.\n\u003c\/p\u003e\n\u003ch5\u003eBiography\u003c\/h5\u003e\n\u003cp class=\"p1\" data-mce-fragment=\"1\"\u003e\n\u003cstrong data-mce-fragment=\"1\"\u003e\n\u003cmeta charset=\"utf-8\"\u003e\n\u003cspan data-mce-fragment=\"1\"\u003eAuthor(s):\u003c\/span\u003e \n\u003c\/strong\u003e\n\u003cspan data-mce-fragment=\"1\"\u003eDr. Aman Grewal is a clinician \u0026amp; healthcare manager turned solicitor with clinical, management and the Royal Australian Air Force Reserves experience. He is the Principal Solicitor\/Director of Medical Injury Lawyers \u0026amp; Consulting Services.\u003c\/span\u003e\n\u003c\/p\u003e\n\u003ch5 class=\"p1\" data-mce-fragment=\"1\"\u003e\n\u003cspan data-mce-fragment=\"1\"\u003eReviews\u003c\/span\u003e\n\u003c\/h5\u003e\n\u003cp class=\"p1\" data-mce-fragment=\"1\"\u003eThis title is currently being reviewed. Please check back for further updates in due course.\u003c\/p\u003e","brand":"Ethics Press","offers":[{"title":"Paperback","offer_id":44866800025642,"sku":"spm1789711076526","price":25.42,"currency_code":"USD","in_stock":true},{"title":"Hardback","offer_id":44866800058410,"sku":"qrw1789711076527","price":88.33,"currency_code":"USD","in_stock":true},{"title":"eBook","offer_id":44866800091178,"sku":"jur1789711076528","price":26.65,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0721\/0709\/8154\/files\/a-critical-review-of-australias-regulatory-oversight-for-new-generation-personal_1.jpg?v=1789711081","url":"https:\/\/layerreadywear.shop\/products\/a-critical-review-of-australias-regulatory-oversight-for-new-generation-personalised-medical-devices","provider":"My Store","version":"1.0","type":"link"}