目的探讨质量受权人制度的实施现状、可行性及存在的问题。方法对部分药品、医疗器械生产企业的质量受权人制度实施状况进行统计分析。结果与结论质量受权人为企业的关键人员,主要负责本企业药品或医疗器械生产全过程的质量监督和质量检验工作,资质成熟的质量受权人能为企业的产品质量严格把关。现阶段的质量受权人制度尚不成熟,需要进一步探索。 Objective To explore the status quo, feasibility and existing problems of the quality of attorney system. Methods The statistic analysis was carried out on the implementation status of quality attorney for some pharmaceuticals and medical device manufacturers. Results and Conclusions Quality Attorney is the key personnel of the enterprise, which is mainly responsible for the quality supervision and quality inspection of the whole process of the production of pharmaceuticals or medical devices of the enterprise. The qualified attorneys of qualified qualification can strictly control the quality of the products of the enterprise. At this stage the quality of the attorney system is not yet mature, and needs further exploration.