Medical Devices Act Article 50

If there is concern about the safety or therapeutic effect of medical devices that have been approved for manufacture or import or have completed the listing, as re-evaluated and confirmed by the central competent authority during the period of validity of their manufacture or import license or listing, medical device firms may be ordered to make corrections within a time period. When necessary, they may be ordered to withdraw, recall, or suspend the manufacture, import, or sale. For those who fail to make corrections within the time period or if there is a serious safety concern, their licenses or listings may be cancelled.