The Therapeutic Goods Administration is the Australian regulatory authority for therapeutic goods such as pharmaceuticals, blood products and tissues, or medical devices. It also ensures access to new therapeutic goods for the population and protects public health though the Therapeutic Goods Act 1989 (the Act). The TGA is a division of the Australian Department of Health and Ageing, part of the Department of Health.
In matters of medical device safety, quality, and performance, the TGA is advised by the Advisory Committee on Medical Devices (ACMD), formerly known as the Medical Device Evaluation Committee (MDEC). This committee also oversees premarket conformity assessment and post market monitoring of medical devices.
A list of TGA regulations can be found here on our website.
Contact details:
Medical Device Associations in Australia:
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多以下列出中国国家食品药品监督管理局(CFDA)对於医疗器械公司会造成重大影响的文件,不过所提供的文件都只限於中文版。
阅读更多