我国医疗器械检验机构的现状及发展战略研究

Status and Development Strategy of Testing Institutes for Medical Devices in China

目的:为我国医疗器械检验机构设置提供参考依据。方法:简要介绍了我国医疗器械检验机构的发展轨迹,对目前54家医疗器械检验机构从主要职能、分布情况、人员结构、检验资质、实验室面积及仪器装备进行分析研究。结果与结论:针对存在的问题及即将开放的市场,应该进一步明确全国医疗器械检验机构体系建设的整体规划,履行属地监管职责,科学整合检验机构,制定合理的医疗器械检验机构能力建设标准。

Objective： To provide some references for the structuring of the testing institutes for medical devices in China. Methods： The development history of testing institutes for medical devices in China was briefly introduced. The current status of the 54 testing institutes was described from aspects of responsibility, distribution, personnel structure, profi ciency, size of labs, instruments and equipment. Results and Conclusion： Targeting at the existing problems and the market about to open, it is suggested that the government further clarify the national overall plan of system construction of the testing institutes for medical devices, fulfi ll supervision duties based on territorial principle, scientifi cally integrate testing institutes and establish a rational standard of ability construction of the testing institutes for medical devices.