中國(guó)創(chuàng)新醫(yī)療器械特別審批程序介紹(顧漢卿)-新版特別審(編輯修改稿)
2025-02-06 01:39 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 Evaluation, SFDA should give priority to the technical review。 after the technical evaluation, SFDA is priority to administrative approval. 三、申報(bào)創(chuàng)新醫(yī)療器械特別審批應(yīng)準(zhǔn)備哪些資料 ? III. What information should be ready for declaring the special approval of innovative medical devices? 業(yè)法人資格證明文件； 產(chǎn)權(quán)情況及證明文件； 過(guò)程及結(jié)果的綜述； person qualification certificates of the applicant。 property information and supporting documents of products。 of product development process and results。 件，至少應(yīng)當(dāng) 包括： ①產(chǎn)品的預(yù)期用 途； ②產(chǎn)品工作原理 / 作用機(jī)理； documents of products should include at least 1) The intended use of products。 2) The working principle and mechanism of products。 ③產(chǎn)品主要技術(shù)指標(biāo)及確定依據(jù)，主要原材料、關(guān)鍵元器件的指標(biāo)要求，主要生產(chǎn)工藝過(guò)程及流程圖，主要技術(shù)指標(biāo)的檢驗(yàn)方法。 3) The main technical indicators and basis of products, the main raw materials, the index requirements of key ponents, the main production process and flow chart, and the testing method of main technical indicators. 性文件，至少應(yīng)當(dāng)包括： – ①信息或者專(zhuān)利檢索機(jī)構(gòu)出具的查新報(bào)告； – ②核心刊物公開(kāi)發(fā)表的能夠充分說(shuō)明產(chǎn)品臨床應(yīng)用價(jià)值的學(xué)術(shù)論文、專(zhuān)著及文件綜述； 5. Documented evidence of product innovation include at least 1) The testing report issued by information or patent search agency。 2) Academic papers, monographs and documents review published in core journals that can fully explain the clinical application value. – ③國(guó)內(nèi)外已上市同類(lèi)產(chǎn)品應(yīng)用情況的分析及對(duì)比（如有）； – ④產(chǎn)品的創(chuàng)新內(nèi)容及在臨床應(yīng)用的顯著價(jià)值。 3) Analysis and parison in the application of similar products already listed on the market at home and abroad (if any)。 4) The innovation content of products and significant value in clinical application. 管理報(bào)告。 。 符合創(chuàng)新醫(yī)療器械要求的資料。 6. A report on safety and risk management of products. 7. Product Manual. 8. Other supporting information that can prove to meet the requirements of innovative medical devices. 托中國(guó)境內(nèi)的企業(yè)法人作為代理人或者由其在中國(guó)境內(nèi)的辦事機(jī)構(gòu)提出申請(qǐng)，并提交以下文件： overseas applicant shall entrust a legal person of enterprise in China as an agent or by its offices in China, apply for and submit the following documents: ①境外申請(qǐng)人委托代理人或者其在中國(guó)境內(nèi)辦事機(jī)構(gòu)辦理創(chuàng)新醫(yī)療器械特別審批申請(qǐng)的委托書(shū)； 1) Overseas applicants entrust agent or its offices in China to deal with the power of attorney in the applications of special approval for innovative medical devices. ②代理人或者申請(qǐng)
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