《医疗器械监督管理条例》(简称《条例》)设定的医疗器械行政许可制度主要包括生产许可,经营许可以及产品注册许可,它们在实施过程中还存在许多亟待解决的问题。文章认为应该利用《条例》修订的机会,在保持原有许可种类的前提上对现行医疗器械行政许可制度进行框架重构和内容优化,以解决既存的问题。 The medical device administrative permission system set forth in the Regulations on the Supervision and Administration of Medical Devices (“the Regulations”) mainly includes the production license, the business license and the product registration permission. There are still many problems to be solved in their implementation. The article thinks that we should make use of the opportunity of the revision of the “Regulations” to reconstruct the framework of the current medical device administrative licensing system and optimize the content on the premise of maintaining the original license types so as to solve the existing problems.