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Australia: Doing Business and Investing in ... Guide Volume 1 Strategic, Practical Information, Regulations, Contacts
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.
Infection prevention and control (IPC) is everybody's responsibility. Healthcare-associated Infections in Australia is the first Australian text to address the challenges posed by infectious diseases and healthcareassociated infections (HAIs) for all members of the multidisciplinary healthcare team. Drawing on the expertise of a wide author team, and based on current research, this important and comprehensive text provides a clear pathway for the reader to increase their knowledge and understanding of IPC. The text is designed for both students and practising clinicians, and is presented in two sections - Principles and Practice - for ease of use. With IPC principles and guidelines now embedded into all health-related curricula, and mandated by standards and guidelines across all areas of healthcare, this is a book no health professional should miss. - Includes practice tips, case studies and video-based learning materials providing real-life examples across more than 20 health professions - Suitable for increasing IPC knowledge across all members of the multidisciplinary team. Content is pitched at different levels, with examples ranging from novice to expert - Aligned to the Australian National Infection Control Guidelines 2019 and the NSQHS Standard Preventing and Controlling Healthcare Associated Infections, as well as the nine hospital-acquired complication (HAC) HAIs addressed in specific chapters - Endorsed by the Australian College for Infection Prevention and Control (ACIPC) and the Australian Society for Infectious Diseases (ASID) - Supported by a companion text, Epidemiology of Healthcare-associated Infections in Australia, providing data on the epidemiology of healthcare-associated surveillance in Australia Instructor and Student resources on Evolve: Multiple Choice Questions Case Studies Abbreviations and Glossary Useful Websites / Resources Video-based learning materials
An enclyclopedic view of doing business with Australia. Contains the how-to, where-to and who-with information needed to operate internationally.