2014年6月1日,新修订的《医疗器械监督管理条例》正式实施,之后有关医疗器械监督管理的新规定相继发布。新规定中对医疗器械委托生产有了新的更具体的规定,本文通过民法法理分析,结合新规中有关医疗器械委托生产的规定,分别从委托双方资质、委托生产的产品、相关罚则等方面法律问题进行探讨,并提示医疗器械生产企业想要委托生产或受托生产在实际工作中该如何操作。 On June 1, 2014, the newly revised “Regulations on the Supervision and Administration of Medical Devices” came into force. Later new regulations on the supervision and administration of medical devices were released one after another. In the new regulations, there are new and more specific provisions on the commissioned production of medical devices. Based on the analysis of the jurisprudence of civil law and the regulations on the commissioned production of medical devices in the new regulations, this article analyzes the qualifications of the two parties entrusted with the production of the products, the relevant penalties, etc. Legal issues to be explored, and prompt medical device manufacturers want to commission or production in the actual work of how to operate.