The central competent authority may designate product items and specific time periods for medical devices that have been approved for manufacture or import or have completed the listing, and order medical device firms to monitor their safety according to the announced or approved safety monitoring plan. Medical institutions shall provide medical device firms with relevant safety monitoring data.
Medical device firms set forth in the preceding paragraph shall prepare and submit safety monitoring reports to the central competent authority periodically. For those who fail to submit safety monitoring reports periodically or whose products have safety concern as deemed by the central competent authority, or if the methods and content for implementation of the safety monitoring plan do not comply with the original announcement or approval, they may be ordered to make corrections within a time period or extend the monitoring period. When necessary, they may be ordered to suspend the manufacture, import, or sale. If the circumstances are severe, their licenses or listings may be directly cancelled.
Regulations governing the methods of submission, time period, contents, formats, restriction and maintenance of the collected data, monitoring period, evaluation referred to in the preceding two paragraphs, and other related matters in regard to the safety monitoring data and reports shall be established by the central competent authority.

Medical device firms or medical institutions shall report any serious adverse events caused by medical devices to the central competent authority.
Regulations governing the conditions, reporting methods, time period, contents, and other matters to be complied with in regard to the serious adverse events referred to in the preceding paragraph shall be established by the central competent authority.

Upon the finding that a medical device is likely to cause harm to the health of human body, the holders of the medical device license or those who have completed the listing shall immediately and proactively report to the central competent authority and undertake corrective and preventive measures.
The corrective and preventive measures set forth in the preceding paragraph include preparation of advisory contents, replacement of parts and accessories, product testing, suspension of use, product recall, or other necessary measures, and shall be disclosed in a reasonable manner for awareness of medical institutions, medical device firms, and users.

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.