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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

This article was also published on Medical Device Summit An increasing number of Western device companies have been acquiring or entering into joint ventures with Asian medical firms. Acquisitions and joint ventures with Asian medical companies can provide many advantages for Western... Read More

This presentation provides an overview of the Asian medical device markets and covers important regulatory issues for specific Asian countries, including China, Japan, India, Thailand, and Vietnam.   To view these presentation slides, please click on Asia Medical Device Markets Overview Presentation  ... 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

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

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

This report on Asian CROs provides a comprehensive list of contract research organizations in Asia. The countries covered include: Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia, Thailand and Vietnam. Included for each CRO are contact information, description of... Read More

From April 2013, a new group of imported drugs will be eligible for fast-track approval in Taiwan. These include chemical drugs that have been on the market for more than ten years in the following countries: Japan, Germany, Belgium, France, Austria, Switzerland,... Read More

Demand for orthopedic devices is surging across Asia, as people there become older and wealthier. Sales of knee implants, hip implants, trauma devices and other orthopedic products have experienced double digit growth since the early 2000s. However, although half of the world's... Read More