Updated on 18 December 2012
Does the ITRI also provide registration services and help with the regulatory process work to companies?
That is one of the services that we can provide. We can prepare the documents for FDA. ITRI also does the testing for Taiwanese FDA. For example, some of the devices or tests cannot be performed in the industry. We will come out with the testing for it and regulated by the TFDA.
By doing that we also become a party of the State Food and Drug Administration in China. They are looking for somebody who can test some of the innovative devices and come out with testing strategies as well as the regulatory guidelines of Taiwan. So, in Taiwan we are working with China on how to set up the regulatory guidelines specifically for the Chinese market. Most of the approved drug or device are tested on Caucasians, and some of these medical devices come to China which is a cause of concern.
Also, there is a lack of guidelines for Class II, Class II B and class III high risk devices because some of the new technologies, such as nanotechnology, are pretty new to the regulatory parties all over the world.
The Taiwan government has identified some focus areas in medical devices?