A Critical Review of Australia’s Regulatory Oversight For New Generation Personalised Medical Devices

A Critical Review of Australia’s Regulatory Oversight For New Generation Personalised Medical Devices
Title A Critical Review of Australia’s Regulatory Oversight For New Generation Personalised Medical Devices PDF eBook
Author Aman Grewal
Publisher Ethics International Press
Pages 207
Release 2024-09-16
Genre Medical
ISBN 1804417297

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Australia'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. This 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. The 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. This 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. This detailed study is a key reference work for academic researchers, medical device manufacturers and sponsors, and legal and regulatory experts.

Australia's Health 2012

Australia's Health 2012
Title Australia's Health 2012 PDF eBook
Author
Publisher AIHW
Pages 643
Release 2012
Genre Medical care
ISBN 174249305X

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Oral health of Australian children

Oral health of Australian children
Title Oral health of Australian children PDF eBook
Author Loc G. Do
Publisher University of Adelaide Press
Pages 369
Release 2016-11-01
Genre Medical
ISBN 1925261417

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This collaborative work provides a detailed snapshot of child oral health in Australia. In doing so, it describes the levels of dental caries and its components, dental fluorosis and other oral health conditions and how they vary by social characteristics. It also describes protective factors such as toothbrushing, the use of fluoridated toothpastes and making dental visits. The 2012–14 National Child Oral Health Study (NCOHS) was a cross-sectional study of the child population aged 5 to 14 years in Australia. A total of 24,664 children from 841 participating schools completed the study. The study sample was selected in a complex multistage, stratified sampling design. Sophisticated weighting procedure was employed to adjust for variations in probabilities of selection and response rates. Therefore, this report presents estimates as representative of child oral health in Australia. Information was collected via a parental questionnaire and a detailed dental examination by trained dental professionals.

Oral Health Care

Oral Health Care
Title Oral Health Care PDF eBook
Author Mandeep Virdi
Publisher BoD – Books on Demand
Pages 386
Release 2012-02-29
Genre Medical
ISBN 9535100408

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Geriatric dentistry, or gerodontics, is the branch of dental care dealing with older adults involving the diagnosis, prevention, and treatment of problems associated with normal aging and age-related diseases as part of an interdisciplinary team with other healthcare professionals. Prosthodontics is the dental specialty pertaining to the diagnosis, treatment planning, rehabilitation, and maintenance of the oral function, comfort, appearance, and health of patients with clinical conditions associated with missing or deficient teeth and/or oral and maxillofacial tissues using biocompatible materials. Periodontology, or Periodontics, is the specialty of oral healthcare that concerns supporting structures of teeth, diseases, and conditions that affect them. The supporting tissues are known as the periodontium, which includes the gingiva (gums), alveolar bone, cementum, and the periodontal ligament. Oral biology deals with the microbiota and their interaction within the oral region. Research in oral health and systemic conditions concerns the effect of various systemic conditions on the oral cavity and conversely helps to diagnose various systemic conditions.

Australian Mammal Society

Australian Mammal Society
Title Australian Mammal Society PDF eBook
Author
Publisher
Pages 86
Release 1978-12
Genre
ISBN

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Australia's Dental Generations

Australia's Dental Generations
Title Australia's Dental Generations PDF eBook
Author Gary D. Slade
Publisher
Pages 274
Release 2007
Genre Dental care
ISBN 9781740246545

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Community Pharmacy Australia and New Zealand Edition

Community Pharmacy Australia and New Zealand Edition
Title Community Pharmacy Australia and New Zealand Edition PDF eBook
Author David Newby
Publisher Elsevier
Pages 382
Release 2019-07-16
Genre
ISBN 0729587037

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Community Pharmacy: Symptoms, Diagnosis and Treatment 4e continues to be the trusted guide to differential diagnosis of symptoms commonly seen by Australian and New Zealand community pharmacists. The fourth edition has been carefully and thoroughly revised and reflects changes to over-the-counter drug scheduling and new over-the-counter drugs. In addition, the text highlights trends in pharmacy education and practice, with an emphasis on counselling, communication skills, evidence-based practice and customer requests specific to Australia and New Zealand. 'Practice points' - tips on how to counsel patients about medications Image library to help diagnose common presentations Legal and ethical considerations for medication supply Referral protocols for pharmacist-only medicines Tips on managing specific product requests An eBook included in all print purchases Additional resources on Evolve eBook on VitalSource Student and instructor resources Additional images for ophthalmology, dermatology, stings and bites and musculoskeletal conditions eChapters - 'Evidence-based pharmacy practice' and 'Wound management' Case studies Instructor resources Image collection Additional online content about wound care, stings and bites, ophthalmology, dermatology and musculoskeletal presentations to assist with accurate diagnosis Introduction updated with legal and ethical considerations surrounding medication supply/non-supply Chapter 10 Special Product Requests now incorporates naloxone injection An eBook included in all print purchases