医疗器械检验机构能力与合规性管理的探讨

On Competence and Compliance Management of Medical Device Inspection Organizations

目的:探讨医疗器械检验机构面临的资质认定和日常检验中的疑难问题,以期加强检验结果的合规性管理。方法:回顾医疗器械检验机构资质认定经历,从对机构要求、检验报告、实施状况等方面分析有关法律规章的规定,分析不同时期、不同部门对于医疗器械检验机构能力的管理要求。结果:医疗器械注册管理办法要求的执行依据为医疗器械产品技术要求,但未能列入国家标准化管理和资质认定范围,以及不同部门不协调的管理要求等因素也同时困扰着检验机构。在检验的具体实施中存在出具的检验报告未标注承检机构资质认定标志的现象,其中包括附有管理部门注册抽样单的检验任务,且此类报告已应用于检验分包、临床试验审查、产品注册审批等工作中。结论:建议完善不同监管部门行政规章不协调之处,在市场监管的协调机制内给予规范统一,在各项行政监管中规范应用检验报告。

Objective:To discuss the problems faced by medical device inspection organizations in the qualification approval and daily inspection in order to strengthen the compliance management of inspection results.Methods:By reviewing the experience of qualification approval of the medical device inspection organizations,the provisions of relevant laws and regulations were analyzed from the aspects of institution requirements,inspection reports,implementation results,etc.The management requirements for the competence of the medical device inspection organizations by different institutions in different periods were also analyzed.Results:The implementation of medical device registration management measures should be based on the technical requirements for medical device products,but this requirement was not included in the scope of national standardized management and qualification approval,and the uncoordinated management requirements made by different departments also troubled the inspection organizations.It had been reported that the inspection reports offered in the implementation did not mark the sign of the qualification approval of the inspection organization,including the inspection task with the sampling of IVD by administration,and such incompetent inspection reports had already been applied to subcontracting of inspections,reviews of clinical trials and approval of registration for medical devices.Conclusion:It is suggested to decrease the incoordination of administrative rules and regulations made by different regulatory departments,unify the coordination mechanism under the market supervision,and standardize the inspection reports applied in all kinds of administrative supervisions.