Updated on 19 April 2013
Another recent change made by the Taiwan FDA was allowing sales of Class I medical devices through "virtual channels" beginning in July 2012. Virtual channels are those in which the product cannot be examined in person (including internet, radio, newspapers and television among others). Previously, no medical devices could be sold through virtual channels but now Class I medical device manufacturers can sell their devices this way if they fulfill several requirements: The criterias for sale through virtal channels is that the manufacturer must be registered with the Department of Health (DOH), the manufacturer must have a functioning physical sales channel in Taiwan, and every virtual sales channel must be registered with the DOH.
Problems faced during poduct registration
Although ammendments and changes have been made in regulatory processes in Taiwan, foreign and domestic firms often find it difficult to get their product registered in the island nation. One of the major issues that foreign companies face while trying to get their products registered with the Taiwan FDA is over the 'Country of Origin'.
Currently, TFDA recognizes only the 'actual manufacturer' (the factory that produces the product) rather than the 'legal manufacturer' (the organization to whom the product belongs). This issue usually crops up when components are outsourced and then they are assembled by different makers. This issues also pops up if the company is unable to obtain a Certificate of Manufacturing from the actual manufacturer.
Furthermore, since the Taiwan FDA accepts documentation only from the actual manufacturer, delays may be caused when promotional materials are in the name of the legal manufacturer. Although the Taiwan FDA has been continuously trying to reform its processes to resolve the problems, it has not met with much success yet.