我国医疗器械检验机构产品技术要求预评价工作现状、问题和建议

The Current Situation, Problems and Suggestions of Pre-evaluation of Technical Requirements for Medical Device Testing Institutes in China

目的:通过对国内主要医疗器械检验机构和审评机构的调研,了解相关文件出台后我国医疗器械检验机构产品技术要求预评价工作现状、存在问题,并提出建议。方法:采用发函调研并回收调查表的模式开展相关基础信息的收集。结果与结论:调查表反馈显示,我国医疗器械检验机构对产品技术要求预评价工作普遍重视,并已按文件要求贯彻实施,但在文件条款执行中遇到一些具体问题,主要可概括为企业、审评机构及检验机构对相关文件理解和执行不统一的问题,以及文件执行后生物学评价开展无规可依的问题。建议相关部门能够出台法规细则,加强对官方机构工作人员和企业双方面的培训,建立畅通的机构间交流机制并加强对医疗器械产品生物学评价的规范化管理。

Objective： To understand the current situation, existing problems and to put forward suggestions for pre-evaluation of product technical requirements after the implementation of relevant documents through the investigation of the major medical device testing institutes and evaluation facilities in China. Methods： The relevant basic information was collected using the method of questionnaire. Results and Conclusion： The survey results showed that medical device testing institutes generally paid attention to the pre-evaluation of medical device technical requirements and implemented the requirements of the documents. However, some specific problems were encountered in the implementation of the provisions of the documents, such as nonuniform understandings and implementation of the relevant documents of companies, medical device evaluation centers, and medical device test institutes, as well as no requirement for biological evaluations after the implementation of the documents. It was recommended that the relevant departments should draft detailed documents, strengthen training of staff in official institutes and companies, and establish smooth communication mechanism among institutes to enhance the standardized management of biological evaluations of the medical device.