Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration (TFDA) was established in 2010 to oversee food, drug, and medical device safety and quality. The TFDA deals with risk assessment, inspections, and market approvals for foods, drugs, biotech products, cosmetics, and medical devices.
The Division of Medical Devices & Cosmetics is in charge of the safety and quality control of medical devices, medical device regulation, and clinical diagnostics, as well as IVDs.
A list of TFDA regulations can be found here on our website.
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
阅读更多要在欧盟合法销售体外诊断器械(IVD),您需要拥有证明其符合IVD法规的CE标识。CE标志表明合法制造商已经评估了器械,并且器械符合体外诊断器械指令98/79/EC(IVDD)的基本要求或体外诊断器械法规2017/746(IVDR)的一般安全和性能要求。合法制造商将验证它的器械是否符合所有相关
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