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The statutory framework set out in the Act is supplemented by the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. The central mechanism through which therapeutic goods (being medicines, biologicals and medical devices) are regulated is the Australian Register of Therapeutic Goods ( ARTG ).
Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Some non-medical or allied health services are not covered by Medicare or by standard health insurance, such as dentistry, medical devices and alternative medicine. A person may in addition or as an alternative take out "extras" cover for such treatments. What services are covered and how much is reimbursed and caps that apply vary between funds.
Aftercare is the care and treatment of a convalescent patient. The term is often used in: Convalescence; Patient; Treatment; Hospital; Surgery; BDSM (see: Aftercare ...