国家医疗器械质量监督抽验中样品确认重要性的探究

Exploration on importance of sample validating in quality supervision and inspection for national medical devices

通过讨论省级医疗器械监督抽验中关于样品确认的一则实例,分析《医疗器械监督管理条例》、《国家医疗器械质量监督抽验管理规定(试行)》等法规关于抽验职责及在医疗器械生产、经营、使用领域实施抽样、检验、结果处置和时限等方面的具体规定。针对当前相关法规对抽样确认规定不完善的现状,分析、探讨监督抽验中因抽样样品确认不及时可能给监督抽验工作带来的弊端,寻求合理的解决办法。笔者认为在医疗器械质量监督抽验工作中加强对所抽样品的实际确认十分必要,提出了在监督抽验管理规定中明确对监督抽验各环节抽样样品进行确认等建设性建议。

To analyze the specifications of inspection duties and specification about performing sampling,testing and results handling in the field of medical devices production,management,employment and results handling,and time limits by ＂regulations for the supervision and administration of medical devices＂,＂the provisions for supervision and inspection of medical devices＂,through discussing a living example about sample validating of supervision and inspection for national medical devices.Aiming at the current situation that some regulations formulate about sample validating incompletely,this paper analyzes and discusses malpractice of supervision and inspection work brought by samples failing to be validated in time,and seeks for a reasonable solution.The author thinks that it is quite necessary to validate the collected samples in supervision and inspection of medical devices,and suggests some constructive suggestions such as confirming samples clearly in all steps of supervision and inspection in administrative regulations of supervision and inspection.