Taiwan announces new Medical devices Act for 2018

Although the draft text was not published the TFDA explains the outline of the forthcoming changes.

The publication includes a few items to be expected, like.

  • applications of certain kinds of Class I medical devices will be changed to electronic listing
  • applicants will be required to annually report their devices through an annual declaration system
  • legal entities that lease medical devices and service or repair medical devices are incorporated into medical device dealers
  • manufacturers will have to establish a management mechanism to track medical devices
  • TFDA will also require Good Distribution Practice (GDP) for medical devices

The draft text as english version is available here