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中国颁布新的医疗器械质量管理法规 Read More

Drug Development and Pricing in Korea Read More

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

韩国的药品开发及药品定价 Read More

Explosive demand for medical devices in the Asian markets are attracting Western and local medical device companies. Western medical device companies are increasing sales to Asia with basic models and lower costs of their top-of-the-line products. However, many more local Asian medical... Read More

There is a wealth of opportunities for healthcare companies looking to expand to the Asian markets. This presentation provides an overview of important business and regulatory issues to consider for medical device companies interested in Asia.   To view these presentation slides,... Read More

美国FDA也发布了几份关于复方药物产品的文件，包括： 一份有关符合外包服务设施的现行cGMP（current good manufacturing practice； CGMP）条件的临时指南草案。 两个联邦注册通知，通知说可以用来做复方药物产品的活性药物成分（active pharmaceutical ingredients；API）的提名程序要被重新打开。 一个规则提议，要修正成不了复方药物的药物产品的列表。 对要做复方药物的药店或个人的最后指导。 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

Sourcing medical devices in Asia has become a common practice as more companies are taking advantage of the lower overhead, lower labor costs and increasing technical capabilities available in the Asian countries. Medical device companies can buy and manufacture a wide array... Read More

China's medical device market has grown to $13 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers registering their products in China has grown exponentially. View our webcast to learn about the new regulations in China.... Read More