【摘要】：目的研究國際醫(yī)療器械監(jiān)管機構(gòu)論壇(international medical device regulators forum,IMDRF)醫(yī)療器械注冊申報資料規(guī)范,為完善我國醫(yī)療器械上市前審查工作提供參考。方法對醫(yī)療器械注冊申報資料規(guī)范項目(regulated yroduct submission,RPS)進行文獻研究,并與注冊申報資料規(guī)范(summary technical documetation,STED)、我國要求進行比較研究。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,對醫(yī)療器械注冊申報資料規(guī)范進行理論分析和評價。結(jié)果醫(yī)療器械注冊申報資料規(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)論我國應(yīng)實施醫(yī)療器械注冊申報資料規(guī)范提出的新要求。我國醫(yī)療器械注冊信息化管理水平低是實施RPS項目的主要困難,建議通過跟蹤學(xué)習(xí)發(fā)達國家經(jīng)驗、明確立法地位和建立醫(yī)療器械技術(shù)審評信息系統(tǒng)3個方面加以應(yīng)對。
[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】： 沈陽藥科大學(xué)工商管理學(xué)院;遼寧省藥械審評與監(jiān)測中心;國家食品藥品監(jiān)督管理總局;
【基金】：遼寧省社會發(fā)展攻關(guān)計劃資助項目(2011225028)
【分類號】：R951

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1 李寶林;;醫(yī)療器械注冊產(chǎn)品標準屬性的探討[J];中國標準導(dǎo)報;2013年02期

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