【問(wèn)】：創(chuàng)新醫(yī)療器械特別審查申請(qǐng)表中備注欄有哪些填寫要求？
Q: What are the filling requirements for the remark column in the application form of the special review for innovative medical device?
【答】：行政相對(duì)人應(yīng)完整填寫創(chuàng)新醫(yī)療器械特別審查申請(qǐng)表備注內(nèi)容，要求如下：行政相對(duì)人如實(shí)填寫利益相關(guān)方面的專家 / 單位信息，包括并不限于理化指標(biāo)檢測(cè)、生物性能試驗(yàn)、動(dòng)物試驗(yàn)、臨床試驗(yàn)、合作研究者、知識(shí)產(chǎn)權(quán)買賣方等，并明確申請(qǐng)回避的專家及理由。如有涉及利益相關(guān)的專家，應(yīng)明確專家參與的具體企業(yè)的名稱及具體研發(fā)項(xiàng)目名稱。備注信息不能為空，如無(wú)相關(guān)內(nèi)容可填寫 “無(wú)”。
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.
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