Medical Devices Act Article 27

A medical device manufacture or import license is valid for a period no longer than five years starting from the date of issue. Where it is necessary to continue the manufacture or import upon expiration, a prior application shall be filed with the central competent authority for approval of license extension. Each extension shall not exceed five years.For those who fail to file an application upon the expiration period or if the extension is disapproved, the original license shall become invalid and be cancelled by the central competent authority.In case the license set forth in the preceding paragraph can no longer be used due to stain or damage, an application shall be submitted along with the original license to the central competent authority for replacement. In case of loss, an application for re-issuance shall be filed.