| 关于医疗器械软件变更监管要求探讨 |
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| 引用本文： | 彭亮,袁鹏.关于医疗器械软件变更监管要求探讨[J].中国医疗器械信息,2013(12):15-17. |
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| 作者姓名： | 彭亮 袁鹏 |
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| 作者单位： | [1]国家食品药品监督管理总局医疗器械技术审评中心,北京100044 [2]国家食品药品监督管理总局,北京100053 |
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| 摘 要： | 由于医疗器械软件的特殊性，在产品注册后变更相对频繁，但现在对于医疗器械软件变更的监管要求尚未能充分考虑这种情况，应进一步科学合理设置相应监管要求。本文针对业内人士所关注焦点，分析了医疗器械软件变更类型划分原则，并基于相关变更类型划分，探讨了医疗器械软件变更的监管要求，最后提出了相关工作建议。
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| 关 键 词： | 医疗器械软件 软件变更 监管要求 |
Discussion on Supervision Requirements for Medical Device Software change |
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| PENG Liang,YUAN Peng.Discussion on Supervision Requirements for Medical Device Software change[J].China Medical Devices Information,2013(12):15-17. |
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| Authors: | PENG Liang YUAN Peng |
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| Institution: | 1 Center for Medical Device Evaluation, CFDA (Beijing 100044) 2 China Food and DrugAdministration (Beijing 100053)) |
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| Abstract: | As a result of the medical device software characteristic, the software will have more changes after it has been approved by Authorities. But, now, the supervision requirements can’t cover al circumstances, so, the supervision requirements should been established more Scientiifc and reasonable. This article point at the stakeholder’s concerns, analysis the principle on classiifcation of medical device software change, and base on the types of medical device software change, discuss the Supervision Requirements for Medical Device Software change, then, give the advices. |
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| Keywords: | medical device software change supervision requirements |
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