本文選題：醫(yī)療器械 + 注冊(cè)�。� 參考：《山東大學(xué)》2014年碩士論文

【摘要】：近年來(lái),隨著社會(huì)的高速發(fā)展,科技創(chuàng)新的日新月異,人民大眾對(duì)醫(yī)療保健的需求越來(lái)越高,醫(yī)療器械行業(yè)的發(fā)展無(wú)論是在大眾的醫(yī)療安全中,還是在國(guó)民經(jīng)濟(jì)發(fā)展中都占據(jù)了越來(lái)越重要的位置。 依照相關(guān)規(guī)定,在中華人民共和國(guó)境內(nèi)從事醫(yī)療器械的研制、生產(chǎn)、經(jīng)營(yíng)、使用活動(dòng)及其監(jiān)督管理的單位和個(gè)人,都必須遵守《醫(yī)療器械監(jiān)督管理?xiàng)l例》。依照《條例》,第二類醫(yī)療器械必需經(jīng)注冊(cè)方可批準(zhǔn)生產(chǎn)、銷售。 產(chǎn)品的安全和有效來(lái)源于設(shè)計(jì),設(shè)計(jì)階段就注定了產(chǎn)品的有效性和安全性,本文從醫(yī)療器械產(chǎn)品的注冊(cè)工作入手,從醫(yī)療器械產(chǎn)品的源頭探討醫(yī)療器械行業(yè)存在的問(wèn)題及對(duì)策研究,安徽省食品藥品審評(píng)認(rèn)證中心承擔(dān)著安徽省第二類醫(yī)療器械注冊(cè)產(chǎn)品的技術(shù)審評(píng)工作,本文通過(guò)抽取樣本對(duì)大量安徽省醫(yī)療器械產(chǎn)品注冊(cè)資料的原始數(shù)據(jù)進(jìn)行統(tǒng)計(jì)分析,采用描述性統(tǒng)計(jì)分析方法中的集中程度測(cè)定等方法,梳理出安徽省第二類醫(yī)療器械在產(chǎn)品注冊(cè)中存在的問(wèn)題,并逐一分門別類地對(duì)這些問(wèn)題進(jìn)行詳細(xì)的具體分析。 同時(shí),通過(guò)與安徽省省市級(jí)監(jiān)管部門、技術(shù)機(jī)構(gòu)和醫(yī)療器械生產(chǎn)企業(yè)的相關(guān)人員的訪談?wù){(diào)查,深入了解整個(gè)安徽省第二類醫(yī)療器械產(chǎn)品注冊(cè)工作的現(xiàn)狀,包括存在的問(wèn)題和形成原因,并進(jìn)行詳細(xì)分析論證,最后嘗試進(jìn)一步有針對(duì)性地提出改進(jìn)現(xiàn)狀的對(duì)策和建議。 因國(guó)內(nèi)外相關(guān)專注于醫(yī)療器械產(chǎn)品注冊(cè)的著作文獻(xiàn)很少,筆者力圖通過(guò)撰寫本文來(lái)達(dá)到拋磚引玉的目的,指導(dǎo)生產(chǎn)企業(yè)如何提高產(chǎn)品注冊(cè)通過(guò)的效率同時(shí),希望通過(guò)社會(huì)各界的共同努力,將我省的醫(yī)療器械產(chǎn)品注冊(cè)工作發(fā)展得更完善,更能適應(yīng)未來(lái)醫(yī)療器械行業(yè)發(fā)展的需求。
[Abstract]:In recent years, with the rapid development of society and the rapid development of science and technology, the people's demand for medical care is higher and higher. The development of medical device industry is not only in the medical safety of the public, Still occupy more and more important position in national economy development. In accordance with relevant provisions, units and individuals engaged in the development, production, operation and use of medical devices within the territory of the people's Republic of China, as well as their supervision and administration, must abide by the regulations on Supervision and Administration of Medical Devices. According to the regulations, Class II medical devices must be registered before they can be approved for production and sale. The safety and effectiveness of the product comes from the design, and the design stage is doomed to the effectiveness and safety of the product. This paper starts with the registration of the medical device product. The problems and countermeasures in the medical device industry are discussed from the source of the medical device products. The Anhui Food and Drug Evaluation and Certification Center is responsible for the technical review of the second kind of medical device registration products in Anhui Province. In this paper, we take samples to analyze the raw data of a large number of medical device registration data in Anhui Province, and use the method of concentration measurement in descriptive statistical analysis method. The problems existing in the registration of the second kind of medical devices in Anhui Province are combed out, and these problems are analyzed in detail one by one. At the same time, through interviews with relevant personnel of provincial and municipal regulatory departments, technical institutions and medical device manufacturing enterprises in Anhui Province, we have a thorough understanding of the status quo of the registration of the second kind of medical devices in Anhui Province. Including the existing problems and causes, and detailed analysis and demonstration, and finally try to further improve the current situation of countermeasures and suggestions. Because there are few literature about medical device registration at home and abroad, the author tries to write this article to achieve the purpose of guiding production enterprises how to improve the efficiency of product registration at the same time, It is hoped that through the joint efforts of all walks of life, the registration of medical device products in our province will be more perfect and more suitable for the development of the medical device industry in the future.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R955

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本文編號(hào)：1792006