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
Taiwan might be an economic lightweight compared to its mainland cousin, but in the medical device market, the island nation of 23.3 million makes up for its small size. It has a medical device market of $2.5 billion, the fifth-largest in Asia.... Read More
Beginning January of 2013, the Taiwanese Food and Drug Administration (TFDA) will begin trial of the Essential Principles (EP) and Summary of Technical Documentation (STED) format for class III devices, with mandatory EP/STED required for all 2014 submissions. The move is part... Read More
The Taiwanese Food and Drug Administration (TFDA) announced that its registration and market approval documentation requirements will align with the Common Technical Document (CTD) format for e-submission. Use of the CTD format should reduce costs, labor, and time required for new drug... Read More
In June 2012, Taiwan’s Department of Health (DOH) announced that it would allow the sales of low-risk Class I medical devices through “virtual channels” starting July 2012. Virtual channels are any instances in which the medical device cannot be examined by customers... Read More
On May 1, 2012, the Taiwan FDA (TFDA) announced its plan to move towards Summary Technical Documentation (STED). This move is to align with GHTF SG1-N11:2008, Summary of Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of... Read More
Innovator pharmaceutical companies will soon have their branded sales heavily affected in the Asian pharmaceutical markets. This is due to the fact that pharmaceutical products collectively expected to generate $21 billion will go off patent over the next five years. Brand pharmaceutical... Read More
Over 2.5 million of Taiwan’s total population (23 million) is accounted for by citizens aged 65 or above. This figure constitutes nearly 11% of the population and is expected to increase to 20% by 2015. Average life expectancy in Taiwan is also... Read More
The number of cancer cases is dramatically increasing in countries throughout Asia. Asia now accounts for about 50% of all new cancer cases in the world, or about 6 million new cancer cases annually. The most common cancers in Asia are: lung,... Read More
On Aug. 19th 2011, the Taiwan Cabinet commenced the Taiwan Medtech Fund (TMF). TMF aims to increase investment in high-end medical devices in Taiwan. The fund plans to raise about $173 million over the next few months. Taiwan has been in talks... Read More