关于医疗器械软件变更监管要求探讨

Discussion on Supervision Requirements for Medical Device Software change

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。

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.