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