江苏昌吉永生物科技股份有限公司
“非洲国家医疗卫生政策及产业现状研究”项目介绍
Jiangsu Chukeu Biotechnology Co.,Ltd.
Introduction of the program "Research on health policy and industry status in African countries"
一、项目名称：非洲国家医疗卫生政策及产业现状的研究
●Topic of the Program ：
Research on health policy and industry status in African countries
二、项目研究的意义
●Significance of the program:
非洲人口占世界人口六分之一。非洲是共建“一带一路”的历史和自然延伸，是重要参与方。产业合作与基础设施是“一带一路”建设的两大领域，近些年，中国和非洲在这两方面充分合作，让非洲国家的经济发展插上了翅膀。中国企业也在非洲设厂投资，在非洲的中国企业数量十几年间翻了数倍。
Africa has one sixth of the world's population. Africa is a historical and natural extension of the "The Belt and Road" and an important participant.Industrial cooperation and infrastructure are two major areas of "The Belt And Road" construction. In recent years, China and Africa are fully cooperated in these two areas, which has helped African economies develop their by leaps and bounds.And chinese companies have set up factories and invested in Africa, where the number of Chinese companies has multiplied several times in a decade.
近年来，我国的医疗器械企业积极“走出去”，开展国际化合作，尤其是到“一带一路”沿线国家投资建厂，为当地市场提供价廉物美质优的中国商品，有效改善了所在国百姓的民生。我国医疗器械企业经过多年努力发展具有了一定的“走出去”的能力和实力。
In recent years, Chinese medical device enterprises have been actively "go abroad"，to carry out international cooperation, especially to invest and set up factories along the "Belt And Road" country .In order to provide cheap, high-quality and excellent Chinese goods for the local market, effectively improving the people's livelihood. After years of efforts, Chinese medical device enterprises have developed the ability and strength of "go abroad".
江苏昌吉永生物科技股份有限公司坐落于历史文化名城江苏镇江，致力于高端生物医用新材料及相关应用产品的研发、生产和销售。公司现有一支以国家“百千万”人才、博士生导师为首的生物医学高科技研发团队，包含归国博士、高级工程师以及一批硕士研究员及其他实验人员，与国内多所著名的高校、科研院所及欧洲多家研发机构建立了稳定良好的研发战略合作关系。公司技术力量雄厚，具有先进的生产设备、一流的医疗器械研究和开发能力。目前已获得十二项专利授权，其中发明专利六项。公司已通过ISO13485质量管理体系认证（TUV），现有的产品方向包括：透明质酸钠可吸收止血海绵系列产品（专利产品）、医用伤口敷料系列产品和功能性敷料系列产品。目前已有医用水凝胶创伤敷料（江苏省高新技术产品）、一次性医用水凝胶眼贴等7个产品已获得二类医疗器械注册证，并通过欧盟CE认证，冷敷贴、液体敷料等7个产品获得一类医疗器械产品备案凭证。公司本着海纳百川、健康大众的理念，务实敬业、全力创新，致力于发展成为高端生物敷料的领军企业。
Jiangsu chukeu biotechnology co., ltd. is located in the historical and cultural city ,zhenjiang, jiangsu province, which is devoted to to the development, production and sales of high-end biomedical new materials and related products. The company has a doctoral tutor biomedical high-tech research team lead by Dr studied abroad, senior engineer and a group of researchers and other experimenters, whom set up stable and friendly strategic cooperative relations with many domestic famous universities, research institutes and several European research and development organizations.The company has strong technical force, advanced production equipment, first-class medical equipment research and development capabilities. At present, 12 patents have been granted, including 6 invention patents. The company has passed the ISO13485 quality management system certification (TUV), and its current products include:Hydrogel Dressings，Functional Dressings，Disposable Medical Consumables，First Aid Kits
三、研究内容
●The research content
1、非洲国家（参与者本国）医疗卫生政策、法规调研；1、Research on medical and health policies and regulations in African countries (participants' own countries); 2、Medical and health status and industrial development in African countries; 3、对企业响应“一带一路”走出去与非洲国家投资合作的方案建议。3、The suggestion and plan for chinese enterprises who respond to the " Belt And Road" policy to go out invest and cooperate with African countries.
四、项目研究大纲
●Program research outline
1、留学生来自国家基本情况的介绍以及自身专业、能力、背景的介绍；1、 Introduction of the basic information of the foreign students include the nationality, majors, abilities and backgrounds as well as the country status2、国家人口以及医疗状况：人口数量、男女比例、老年人占比、医疗体系等；2、 National population and medical status:amount of Population, ratio of male to female, proportion of the elderly, medical system, etc.; 3、国家医疗制度：医疗保险政策及实施情况、医保产品目录等；3、 National medical system:Medical insurance policies and implementation, medical insurance product catalog, etc.; 4、国家医院相关情况：公立医院及私立医院数量及配套情况，每年就医数量；有多少医院从事烧烫伤、战伤、以及其他创伤的专科，目前医院都在使用哪些产品；这些产品的来源以及如何选择进入医院；医院和医疗保险和这些商业配送企业如何结算；4、Related information of national hospitals:The number of public and private hospitals and their supporting facilities condition, the number of patient per year; the number of hospitals which specialized in burns, war injuries, and other injuries treatment, and what products are currently being used in hospitals; Where these products come from and how they are selected for admission to hospitals; How hospitals and medical insurance and these commercial distribution companies settlement; 5、参与学生本国医疗器械生产企业的情况；主要生产企业或研发机构的名称、研发生产的医疗器械产品名称及类别、在本国内的应用情况和年度销售的数量、去向等；5、The status of medical device manufacturers of the participants' countries; The name of the main manufacturing enterprise or research and development institution; the name and category of the medical devices; the status in use in the country and the quantity of the annual sales and sales destination;6、国外医疗器械产品进入参与学生国家的渠道、政策和操作方式；（不限于以下三种方式） 一是国际组织采购。由联合国基金、国际红十字会、世界卫生组织、联合国儿童基金会等国际组织通过一些基金免费向非洲困难地区提供药品，免费药品主要是针对艾滋病、疟疾、结核和禽流感四类疾病的。二是国际组织将一部分全球资金和募集款分给非洲各国家，非洲国家公立医院实行政府采购。目前，国际组织采购参照的是世界卫生组织每年发布的各类疾病推荐用药以及推荐供应商采购目录。三是私营市场,包括药店、药房、私立医院和诊所。外国药品要进入非洲的私营市场,需获得各国政府部门的审批,具体到各个国家情况各异。6、what's the Channels, policies and operation modes of foreign medical device products entering into your country ?(not limited to the following three ways)Firstly, procurement by international organizations. Such as the United Nations fund,the international Red Cross,the world health organization ,UNICEF provide drugs to some poor region of Africa through some free funds.and these free drugs are mainly for HIV/AIDS, malaria, tuberculosis and bird fluSecondly, international organizations distribute part of the global funds and funds raised to African countries, and public hospitals in African countries are subject to government procurement. Currently, procurement by international organizations is based on the W.H.O annual list of recommended drugs for various diseases and recommended purchase list. Thirdly ,the private market ,include drug store、private hospital and clinic.It has to get the approval from the govenment,when the drug from abroad enter into africa market .The situation is various from country to country .7、医疗器械类别：有没有对应的医疗器械分类目录？免临床产品目录？7、Categries of Medical devices :Is there any corresponding catalogue of medical devices?Free clinical product catalog?8、产品许可条件：是否需要拿到《进口产品注册证》？如果需要，具体的产品注册证的申领流程？具体工作要求及产品注册证的注册周期？注册费用？是否有专业代理机构？官方管理发证机构是哪个？ 8、Product license conditions：Do we need to get the<<import product registration certificate>>? If necessary, what is the specific application process for the product registration certificate? Specific requirements and registration period to get the certificate?Fees for registration ?Is there any professional agent for the registration ?Which is the official license issuing agency?9、医疗器械质量体系：是否同样依据ISO13485建立医疗器械体系？认可欧盟CE、美国FDA或其他哪些认证？9、Medical device quality system: is the medical device system established according to ISO13485?Do the CE, FDA or other certification accept ? 10、生产许可条件：医疗器械上市前是否需要拿到《医疗器械生产许可证》？具体的生产许可证的申领流程、具体工作要求及周期？ 10、Production license conditions：Does medical device need to get<<medical device production permit>> before sell on the market?Specific production license application process, specific work requirements and time period ?11、硬件（洁净厂房、设备等）要求：医疗器械生产是否有行业规范？不同类别医疗器械对生产厂房是否有具体的净化洁净度的要求？（比如中国国内的《医疗器械生产质量管理规范》）。11、Hardware (clean plant, equipment, etc.) requirements:Is there any industry specification for the production of medical devices? Do different types of medical devices production call out specific purification requirements for the production plant? (for example, China's <<medical device production quality management standard >>).12、《****产品注册证》、《医疗器械生产许可证》申请顺序？比如：是先拿到《***产品注册证》再拿到《医疗器械生产许可证》才允许产品上市销售？还是先拿到《医疗器械生产许可证》再拿到《***产品注册证》才允许产品上市销售？12、what's the applicate order for <<****product registration licence>>、<<medical device production permit >> ?Such as :Does the product allowed to be sold on the market under the condition to get <<***Product registration licence>>first ,then <<medical device production permit>> thereafter ?Or the order to get <<medical device production permit>> ,then <<***Product registration licence>>?13、参与学生在本国是否有政府各方面的资源以及熟悉的生产或销售企业可以引入与中国企业技术或商业合作？13、Do the participating students have the resources of the government in various aspects in their countries and are familiar with production or sales enterprises that can be introduced to start technical or commercial cooperation with Chinese enterprises? 14、总结报告：根据以上调研情况进行分析总结，提出中国企业如何与参与学生本国在医疗卫生领域与政府、企业的合作方案、路径、建议等14、summary of report :Based on the above investigation and analysis, this paper puts forward the cooperation plans, paths and Suggestions on how chinese enterprises set up cooperation in medical field with the invested country's government and enterprises.四、项目评选方案
●Awards:
1、针对每位参与活动的学生研究报告，评选出一等奖、二等奖、三等奖。所有参加同学均可获得参与奖励。（具体奖励及奖品形式由江苏大学海外学院与江苏昌吉永生物科技股份有限公司商议确定）1、According to the quality of the research report ,will be select first award ,second award ,third award and the participate awards .All the students who participate the activity will get theparticipate award . first prize :1 person RMB 5000 second prize: 2 persons RMB 3000 Third prize 3 persons RMB1000 or equivalent value gift.Participate award: RMB 500 yuan or equivalent value gift 2、评选方式：由江苏大学海外教育学院与江苏昌吉永生物科技股份有限公司联合成立评审小组，根据研究报告的质量评比和现场答辩两个部分综合评价，最终确定获奖名次。2、Method of Selection :According to the quality of the research report and the comprehensive evaluation of the on- site defense 3、对于获得一等奖、二等奖、三等奖的同学，将授予江苏昌吉永生物科技股份有限公司在留学生所在国家的“昌吉永非洲形象大使”称号；可定期参加江苏昌吉永生物科技股份有限公司举办的各种沙龙活动，可以根据个人情况提供寒暑假到企业实习、参与合作研究项目、参加昌吉永公司在非洲各类展会和非洲合作的外访活动等机会。3、For the students who win the first, second and third prizes, Chukeu will be awarded the title of "chukeu Africa image ambassador of your country".and you can regularly participate in various salon activities held by Chukeu ,and we also provide opportunities to intern in chukeu enterprise during winter and summer vacation, participate in cooperative research programs and various of oversea exhibitions in Africa and foreign visits for African cooperation based on your personal situation.五、项目时间节点
●Time node of the program
2019年12月15日～2020年03月31日
15/12/2019-31/03/2020
