医疗器械已经和药品一样,成为医疗卫生服务中不可缺少的重要产品,一旦产品质量出现问题,将会引起严重的群体事件,影响政府的公信力。因此,我国政府通过制定各类标准、规范等措施对其进行严格监管,控制产品质量,以确保消费者使用器械的安全、有效。为了提高对北京市医疗器械经营企业市场监管的有效性,北京市食品药品监督管理局(原北京市药品监督管理局,以下简称市食药局)经过多方考证、讨论,对验收条款进行了重新修改,在实际工作中也确实取得了实效,但同时也暴露了一些问题。本文以北京市海淀区食品药品监督管理局(以下简称海淀区食药局)对医疗器械经营企业监督检查为例,对医疗器械经营企业现存的几个突出问题进行探究,分析医疗器械市场监管中存在的问题和成因,并对检查验收标准的个别条款内容的进一步完善提出相应的政策建议,为完善北京市医疗器械市场监管提供参考。 Medical devices have become an indispensable and important product in medical and health services, just like medicines. Once a product quality problem occurs, it will cause serious group events and affect the government’s credibility. Therefore, the Chinese government strictly regulates various standards and regulations to control the quality of products so as to ensure that consumers use the devices safely and effectively. In order to improve the effectiveness of market supervision of Beijing’s medical device manufacturers, the Beijing Food and Drug Administration (formerly known as the Beijing Municipal Drug Administration, hereinafter referred to as the Municipal Food and Drug Administration) has undergone many researches and discussions, and has re-examined the terms of acceptance. The revision has indeed achieved practical results in practical work, but it also exposed some problems. This article takes Haidian District Food and Drug Administration of Haidian District (hereinafter referred to as the Haidian District Food and Drug Administration) as an example of supervision and inspection of medical device operating companies and explores several outstanding problems existing in medical device operating companies, analyzing the market supervision of medical devices. The existing problems and causes, and the corresponding improvement of the individual clauses of inspection and acceptance standards, propose corresponding policies and suggestions, and provide reference for improving the supervision of the medical device market in Beijing.