Medical Devices Act Article 34

Manufacturers exporting domestically manufactured medical devices to foreign countries may apply to the central competent authority for certificates required by the countries where such medical devices are to be exported.Medical devices set forth in the preceding paragraph may be restricted for export when the central competent authority deems that there is a concern of insufficiency to meet domestic demand.Medical devices that are approved to be manufactured for export only shall not be sold domestically. However, this shall not apply when the central competent authority deems that there is a concern over domestic demand.Medical device firms holding licenses of necessary medical devices announced by the central competent authority shall, in the case of incapable to continue to manufacture, import, or the likelihood of insufficient supply of said medical devices, report to the central competent authority at least six months in advance; and shall, if unable to report within the aforementioned period due to natural disaster or other incidents not attributable to the medical device firms, report to the central competent authority within 30 days after occurrence of such incidents.The central competent authority may, upon receiving the report set forth in the preceding paragraph or becoming aware of the likelihood of insufficient supply of necessary medical devices, register it on a public website.