Medical Devices Act Article 47

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.