Taiwan’s DOH to Allow Virtual Sales of Low-Risk Medical Devices

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 in person.  These channels include the internet, television, radio, phone calls, newspapers and magazines, etc.

In the past, the DOH allowed no medical devices, regardless of their risk level, to be sold through virtual channels.  Under the new measure, Class I medical devices can be sold through virtual channels if they fulfill several requirements.  Important requirements include:

  1. The medical device manufacturer must be registered with the DOH;
  2. The medical device manufacturer must also have a functioning physical sales channel in Taiwan, in addition to the virtual channels;
  3. The manufacturer must register every virtual sales channel with the DOH. For example, if a Class I device is sold on a website, the manufacturer must register the website address with the DOH. If the manufacturer is found selling a medical device on a website that has not been registered, both the manufacturer and the webmaster of the registered website may be fined.

These requirements protect customers by enabling them to track down medical device manufacturers in case of adverse events.

Under the new policy, the virtual sale of Class II or Class III devices is still not allowed. However, the DOH may eventually consider loosening its grip over the virtual sale of Class II devices if the virtual sale of Class I devices proves to be safe for the general public.