【摘要】：目的研究國(guó)際醫(yī)療器械監(jiān)管機(jī)構(gòu)論壇(international medical device regulators forum,IMDRF)醫(yī)療器械注冊(cè)申報(bào)資料規(guī)范,為完善我國(guó)醫(yī)療器械上市前審查工作提供參考。方法對(duì)醫(yī)療器械注冊(cè)申報(bào)資料規(guī)范項(xiàng)目(regulated yroduct submission,RPS)進(jìn)行文獻(xiàn)研究,并與注冊(cè)申報(bào)資料規(guī)范(summary technical documetation,STED)、我國(guó)要求進(jìn)行比較研究。基于分工原則、行政許可效率、便民原則和系統(tǒng)關(guān)聯(lián)原則,對(duì)醫(yī)療器械注冊(cè)申報(bào)資料規(guī)范進(jìn)行理論分析和評(píng)價(jià)。結(jié)果醫(yī)療器械注冊(cè)申報(bào)資料規(guī)范有利于提升醫(yī)療器械上市前審查的審查能力、審查效率和審查系統(tǒng)性。結(jié)論我國(guó)應(yīng)實(shí)施醫(yī)療器械注冊(cè)申報(bào)資料規(guī)范提出的新要求。我國(guó)醫(yī)療器械注冊(cè)信息化管理水平低是實(shí)施RPS項(xiàng)目的主要困難,建議通過(guò)跟蹤學(xué)習(xí)發(fā)達(dá)國(guó)家經(jīng)驗(yàn)、明確立法地位和建立醫(yī)療器械技術(shù)審評(píng)信息系統(tǒng)3個(gè)方面加以應(yīng)對(duì)。
[Abstract]:Objective to study the data standard of medical device registration and application of (international medical device regulators forumn IMDRF, and to provide reference for improving the pre-market review of medical device in China. Methods A comparative study was carried out between (regulated yroduct documents and (summary technical docuation data (summary technical). Based on the principle of division of labor, the efficiency of administrative license, the principle of convenience and the principle of system association, this paper makes a theoretical analysis and evaluation of the data standard of medical device registration. Results the standard of medical device registration and declaration is helpful to improve the ability, efficiency and systematicness of medical device pre-market examination. Conclusion our country should implement the new request of medical device registration data standard. The low level of information management of medical device registration in China is the main difficulty in the implementation of RPS project. It is suggested that three aspects should be taken to deal with this problem by following up the experiences of developed countries, clarifying the legislative status and establishing a medical device technical evaluation information system.
【作者單位】： 沈陽(yáng)藥科大學(xué)工商管理學(xué)院;遼寧省藥械審評(píng)與監(jiān)測(cè)中心;國(guó)家食品藥品監(jiān)督管理總局;
【基金】：遼寧省社會(huì)發(fā)展攻關(guān)計(jì)劃資助項(xiàng)目(2011225028)
【分類號(hào)】：R951

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