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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).
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.
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 ).
Methylphenidate, in the form of Ritalin pills. The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction.In some countries, such as the United States, they are regulated at the national level by a single agency.
Agency for Medicinal Products and Medical Devices of Croatia Agencija za lijekove i medicinske proizvode (HALMED) 2016 Cyprus: Pharmaceutical Services (CyPHS) 2008 Czech Republic: State Institute for Drug Control Státní Ústav pro Kontrolu Léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) 1997 2005 ...
An Australian Approved Name (AAN) is a generic drug name set by the Therapeutic Goods Administration (TGA) for use in Australia. [1] In late 2016, the TGA changed several drug names to the corresponding international nonproprietary name (INN), or, in cases where an INN was not available (as with asparaginase), another established generic name, such as the United States Adopted Name (USAN).
Thermogravimetric analysis or thermal gravimetric analysis (TGA) is a method of thermal analysis in which the mass of a sample is measured over time as the temperature changes. . This measurement provides information about physical phenomena, such as phase transitions, absorption, adsorption and desorption; as well as chemical phenomena including chemisorptions, thermal decomposition, and ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
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