【问】：创新医疗器械特别审查申请表中备注栏有哪些填写要求？
Q: What are the filling requirements for the remark column in the application form of the special review for innovative medical device?

【答】：行政相对人应完整填写创新医疗器械特别审查申请表备注内容，要求如下：行政相对人如实填写利益相关方面的专家 / 单位信息，包括并不限于理化指标检测、生物性能试验、动物试验、临床试验、合作研究者、知识产权买卖方等，并明确申请回避的专家及理由。如有涉及利益相关的专家，应明确专家参与的具体企业的名称及具体研发项目名称。备注信息不能为空，如无相关内容可填写 “无”。
A:The administrative counterparts should complete the remark column in the application form of the special review for innovative medical device as per below requirements: the administrative counterpart should truthfully fill in the information of experts/units that related to the relevant interests, including but not limited to physical and chemical index testing, biological performance testing, animal testing, clinical trials, the cooperative researchers, the intellectual property buyers and sellers, etc., and specify the experts that applying for avoidance and state the reasons for their avoidance. If there are experts related to the interests, the name of the specific enterprise and the specific R&D project in which the experts are involved should be specified. The remark column should not be blank, “None” can be filled if there is no relevant content.

本文由广州佳誉医疗器械有限公司/佛山浩扬医疗器械有限公司联合编辑