Li Xiao, Zhang Xintao, Hao Qing, Zhu Jiong, Hong Wei
National Institutes for Food and Drug Control, Beijing, 102629.
Shanghai Institute of Medical Device Testing, Shanghai, 201318.
Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Jul 30;46(4):459-463. doi: 10.3969/j.issn.1671-7104.2022.04.022.
This paper puts forward suggestions on the development of diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of diagnostic reagents and ensure the safety use of medical device.
This paper summarizes the quality of diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.
The overall quality of diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.
It is suggested that manufacturers of diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.
针对诊断试剂的发展及上市后产品的监管措施提出建议，以进一步提高诊断试剂质量，确保医疗器械安全使用。
根据2020年国家医疗器械监督抽检结果，总结诊断试剂质量状况并分析问题产生原因。
2020年国家医疗器械监督抽检的诊断试剂整体质量稳定，不合格检出率为1.6%。但存在一些问题，如原材料管理不科学、参考物质制备有缺陷、对标准理解不透彻、说明书管理不重视等。
建议诊断试剂生产企业提高质量管理体系的约束力，强化风险管理意识，重视与监管部门沟通，充分研读标准并加强说明书管理。还建议监管部门加强监督检查，进一步完善评价指导及标准宣传与实施。
