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U.S. Food and Drug Administration News Read More

美国和印度：药品和贸易程序 Read More

U.S. Food and Drug Administration News Read More

U.S. Food and Drug Administration January News Read More

亚太经合组织（APEC）峰会于2014年11月10-11日在北京举行。在峰会上，美国总统奥巴马宣布，美国和中国就扩大目前的信息技术协议达成一致，决定取消所有协议内所列的信息技术产品的税收和关税。此次扩大的协议将覆盖更多的产品，其中包括目前按照8％税率征收关税的医疗器械产品。 过去一年多，为了鼓励中国国内市场的发展，中国拒绝削减产品关税，因为这会有利于美国公司。最近发生的事件预示着美中谈判的突破，对于美国医疗器械公司的发展是一个积极的信号。白宫简报预计，协议的此次扩展将削减约1万亿美元科技产品年全球销售额的关税，其中1000亿来自美国。 Read More

China Agrees to Cut Tariffs on U.S. Medical Devices Read More

The U.S. Food and Drug Administration (FDA) has released a guidance document to better clarify the regulatory processes for molecular diagnostic devices, especially those that can be used for multiple unrelated assays. This includes both approved or cleared functions — such as... Read More

The developing world is experiencing more Western diseases as they consume more Western products such as fast food, leading to a rise in the cardiology, orthopedics, and cancer rates. This means that the developing world is seeing a growing demand for devices... Read More

The U.S. Food and Drug Administration (FDA) has released several important documents. On September 16, 2014, the FDA released a final guidance for abbreviated new drug applications (ANDAs), explaining a variety of specific application deficiencies that may result in the FDA refusing... Read More

The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More