|
| 我国医疗器械注册技术审查指导原则现状探讨 |
| Discussion on the status of Chinese guidence for medical device registration and evaluation |
| 投稿时间：2019-08-28 修订日期：2019-10-23 |
| DOI： |
| 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 Guidence Evaluation Coverage |
| 基金项目: |
|
| 摘要点击次数: 295 |
| 全文下载次数: 0 |
| 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：本文对我国指导原则发布数量、覆盖情况、编制现状等进行了概述、剖析存在问题。结果与讨论：我国指导原的编制则需从数量、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 guidence of medical device registration and evaluation is an important technical document for reviewer in China, which is a powerful tool for improving the quality of registration and evaluation. This paper gives an overview of the current status of guidance in China, as references for medical device personnel.
Methods: This paper summarizes and analyzes the problems of the number, coverage and current status existing in Chinese guidance. Results and Conclusion: The preparation of the guidance in China needs to be considered in terms of quantity, quality and medical device products coverage to meet the rapid development of China"s medical device industry. |
|
View Fulltext
查看/发表评论 下载PDF阅读器 |
| 关闭 |