医疗器械监督抽验中复验问题的研究

      The Research on Reinspection Problems in Supervisory Sampling Inspection for Medical Devices

      • 摘要: 医疗器械的监督抽验是行政监管的措施之一,抽验中的复验问题影响抽验的最终结论。复验不当改判已比较严重地损害了监督检验的公正性和权威性。该文通过调研资料等统计分析了申请复验与改判的原因,提出了解决标准理解、标准缺陷、检验能力、样品问题与其它因素干扰的方案。为提高抽验复验的公信力,提出回避原则、优先原则、仲裁原则与考核原则,改进复验工作流程,使抽验复验工作更为合理、有效、公正。

         

        Abstract: Supervisory sampling inspection is one of the administrative supervision measures for medical devices. As the reinspection work affects the final conclusion of sampling inspection, inappropriate overturn during the reinspection has already impaired the impartiality and authority of the supervisory inspection work. By the statistics of survey materials, this article analyzes the reasons for requesting reinspection and making overturns, and proposes a scheme for eliminating the interference factors such as the understanding divergences and the defects of standards, the inspection capacity and the issues of sampled devices, etc. To enhance the authoritative of reinspection, this article also proposes principals of evasion, precedence, arbitration and assessment, and the improvement of the reinspection workflow in order to make the reinspection work more appropriate, more efficient and more impartial.

         

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