CAJ | 학술논문

医疗器械异地生产的许可管理是生产监管的重要内容，但是目前相关立法中出现了较大的矛盾和困惑，监管实践中也存在着较大的误区。化解困境的正确途径，应该是正确区分医疗器械生产许可的首次申请、许可变更以及许可延续三者之间的内涵，进而作出恰当的监管规定。
의료기계이지생산적허가관리시생산감관적중요내용，단시목전상관입법중출현료교대적모순화곤혹，감관실천중야존재착교대적오구。화해곤경적정학도경，응해시정학구분의료기계생산허가적수차신청、허가변경이급허가연속삼자지간적내함，진이작출흡당적감관규정。
The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.