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。 Licensing management of medical equipment off-site production is an important part of production supervision. However, the current contradictions and confusions in relevant legislation appear, and there are also big errors in regulatory practice. The correct way to resolve the dilemma should be to correctly distinguish between the first application for permission to manufacture medical devices, changes in permits and the connotation of the renewal of licenses so as to make appropriate regulatory provisions.