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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).
Additionally, theriac became a commercial good traded throughout Europe based on the works of Greek and Roman physicians. [ 2 ] The resulting proliferation of various recipes needed to be curtailed in order to ensure that people were not passing off fake antidotes, which led to the development of government involvement and regulation.
The main purpose of the GMDN is to provide health authorities / regulators, health care providers, conformity assessment bodies and others with a single generic naming system. Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. [1]
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]
The ASEAN Medical Device Directive (AMDD) has been adopted by several southeast Asian countries. The nations are at varying stages of adopting and implementing the Directive. The AMDD classification is risk-based and defines four levels: A - Low Risk, B - Low to Moderate Risk, C - Moderate – High Risk, and D - High Risk. [28]
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
Top Senate Republican Mitch McConnell on Wednesday urged the U.S. Supreme Court to reject a bid by TikTok and its China-based parent company ByteDance to block a law intended to force the sale of ...
In 1970, the study committee recommended a classification for medical devices based on comparative risk. [5] In 1976, the Dalkon Shield intrauterine device injured at least 900,000 women in the United States, [ 6 ] which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L. 94-295.