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台湾食品和药物管理局（TFDA）日前宣布，计划从2015年7月1日起修改医疗器械上市许可 审批制度。申请人需要提交质量体系文件（QSD）核准通知书作为初始上市许可申请文件的一 部分。目前，TFDA有时允许申请人初次申请文件提交后几个月后提交这些QSD信件。 行政文件的初步审查后，TFDA将对高风险的医疗器械的临床前试验文件和出厂质量控制文件进行评估。安全性、质量和性能将会被特别审查。注册申请费也将上调。 Read More

The Taiwan Food and Drug Administration (TFDA) recently announced plans to change the country’s medical device marketing authorization approval system starting July 1, 2015. Applicants will need to submit Quality System Documentation (QSD) Approval letters as part of the initial marketing authorization... Read More

China Releases Device Quality System Regulations Read More

中国颁布新的医疗器械质量管理法规 Read More

美国FDA 新闻 Read More

On March 24, 2014, the China Food and Drug Administration (CFDA) announced a 5 month national campaign to reinforce medical device product standards. The campaign will focus on the manufacture, sale and usage of Class 2 and Class 3 devices. Growing at... Read More

3月24日2014年，中国食品药品监督管理局（CFDA）宣布开展5个月的全国医疗器械质量问题的清理工作，提高医疗器械的产业标准。该活动将着重在二，三类医疗器械生产，销售以及使用领域中进行。2013年中国医疗器械市场价值约为130亿美元。然而，医疗器械市场的快速扩张，也意味着出现更多的医疗器械质量问题。 Read More

Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task. This webcast will focus on key steps including PMDA consultation sessions, how to maximize... Read More

The US FDA will increase inspections of Indian drug and medical device manufacturing facilities in response to growing concerns about the quality of Indian medical device and pharmaceutical products. In mid-September, the agency issued the latest of many import alerts against Indian... Read More

Starting July 1, 2013, all new pharmaceutical companies operating in China must comply with China’s Food and Drug Administration (CFDA) revised Drug Quality Control Standards for license approval and GMP certification. Pharmaceutical companies with new, expanded or renovated warehouses or business locations... Read More