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, please... 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
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