四川省医疗器械生产企业无菌和植入性医疗器械生产现况:31家企业调查分析

发布时间：2019-06-06 15:03

【摘要】：背景:国家食品药品监督管理局(以下简称国家总局)于2009年12月16日发布《关于印发医疗器械生产质量管理规范(试行)的通知》,要求于2011年1月1日首先在风险较高的无菌和植入性医疗器械生产企业实施。修订后的《规范》于2014年12月29日公告发布,并于2015年3月1日起施行。目的:分析四川省31家无菌和植入性医疗器械生产企业的现状以及实施《规范(试行)》的情况,并提出针对性建议。方法:通过质量管理体系考核、监督检查、飞行检查、问卷调查等形式收集了四川省31家无菌和植入性医疗器械生产企业的相关数据资料,并对数据进行了统计分析。结果与结论:四川省医疗器械生产企业整体规模偏小,设备不够先进,从业人员素质偏低,资金不足,管理不到位。在此基础上,作者从生产和监管2个方面出发,为《规范》有效实施提出了指导性建议。
[Abstract]:Background: the State Food and medicines Supervision and Administration (hereinafter referred to as the State Administration of Food) issued the Circular on the issuance of quality Management norms for the production of Medical Devices (trial) on December 16, 2009, It is required to be implemented first in riskier sterile and implantable medical device manufacturers on January 1, 2011. The revised Code was announced on December 29, 2014 and entered into force on March 1, 2015. Objective: to analyze the present situation of 31 aseptic and implantable medical device manufacturers in Sichuan Province and the implementation of the Code (trial), and to put forward some suggestions. Methods: the relevant data of 31 aseptic and implantable medical device manufacturers in Sichuan Province were collected by quality management system assessment, supervision and inspection, flight inspection and questionnaire survey, and the data were statistically analyzed. Results & conclusion: the overall scale of medical device production enterprises in Sichuan Province is small, the equipment is not advanced enough, the quality of employees is low, the funds are insufficient, and the management is not in place. On this basis, the author puts forward some guiding suggestions for the effective implementation of the Standard from two aspects of production and supervision.
【作者单位】：四川大学华西药学院;四川省食品药品审查评价及安全监测中心;四川省药械集中采购服务中心;
【基金】：四川省食品药品监督管理局四川省食品药品审查评价及安全监测中心
【分类号】：R95

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