| 商惠,李耀华.我国医疗器械注册技术审查指导原则现状探讨[J].中国药事,2020,34(7):744-748 |
| 我国医疗器械注册技术审查指导原则现状探讨 |
| Discussion on the Status Quo of Guiding Principles for Medical Device Registration and Evaluation in China |
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| DOI：10.16153/j.1002-7777.2020.07.002 |
| 中文关键词: 医疗器械 指导原则 技术审评 覆盖率 |
| 英文关键词: medical device guiding principles technical evaluation coverage |
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| 中文摘要: |
| 目的：医疗器械注册技术审查指导原则作为审评的重要技术文件，是提高注册申报质量和技术审评一致性的有力抓手，对我国指导原则现状进行梳理归纳以供医疗器械相关人员参考。方法：对我国指导原则发布数量、覆盖情况、编制现状等进行概述、剖析存在的问题。结果与结论：我国指导原则的编制需要从数量、质量和产品覆盖率等多方面考量，以满足我国医疗器械行业的迅猛发展。 |
| 英文摘要: |
| Objective: The guiding principle for medical device registration and evaluation is an important technical document for reviewers in China, which is a powerful tool for improving the quality of registration and evaluation. To summarize the current status of guiding principles in China for the reference of medical device related personnel.Methods: This article summarizes the number, coverage and current compilation status of guiding principles in China, and analyzes the existing problems. Results and Conclusion: The compilation of China's guiding principles needs to be considered in terms of quantity, quality, and product coverage to meet the rapid development of China's medical device industry. |
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