1、Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been gi
2、ven support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, w
3、ater, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution,
4、 “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than
5、2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing t
6、imber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “
7、bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral
8、resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary Riv
9、er Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of
10、three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivost
11、ok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Orienta
12、l Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi第十一章 医疗器械、保健食品和化妆品的管理 5-6 分第 01讲 医疗器械、保健食品和化妆品的管理医疗器械管理（3-4 分） 保健食品管理（1 分） 化妆品管理（1 分） 十一、医疗器械、保健食品和化妆品的管理 （一）医疗器械管理1. 医疗器械管理的基本要求（1） 医疗器械的界定：是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，包括所需要的计算机软件；A其效用主要通
13、过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些方式参与但是只起辅助作用；其目的是：X疾病的诊断、预防、监护、治疗或者缓解；损伤的诊断、监护、治疗、缓解或者功能补偿；生理结构或者生理过程的检验、替代、调节或者支持；生命的支持或者维持；妊娠控制；通过对来自人体的样本进行检查，为医疗或者诊断目的提供信息。（2）医疗器械的分类 B X国家对医疗器械按照风险程度实行分类管理。评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。如外科用手术器械（刀、剪、钳、镊夹、针、钩）、听诊器（无电能）、
14、反光镜、 反光灯、医用放大镜、（中医用）刮痧板、橡皮膏、透气胶带、手术衣、手术帽、检查手套、集液袋等。第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。如 血压计、体温计、心电图机、脑电图机、手术显微镜、（中医用）针灸针、助听器、皮肤缝合钉、避孕套、避孕帽、无菌医用手套、睡眠监护系统软件、超声三维系统软件、脉象仪软件等。第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。如 心脏起搏器、体外反搏装置、血管内窥镜、超声肿瘤聚焦刀、高频电刀、微波手术刀、医用磁共振成像设备、钴 60治疗机、正电子发射断层扫描装置（PECT）、植入器材、植入式人工器官、血
15、管支架、血管内导管、一次性使用输液器、输血器等。（3）产品注册与备案管理第一类医疗器械实行备案管理。第二类、第三类医疗器械实行注册管理。 B境内第一类医疗器械备案，备案人向设区的市级药品监督管理部门提交备案资料。境内第二类医疗器械由省级药品监督管理部门审查，批准后发给医疗器械注册证。境内第三类医疗器械由国家药品监督管理部门审査，批准后发给医疗器械注册证。进口第一类医疗器械备案，备案人向国家药品监督管理部门提交备案资料。进口第二类、第三类医疗器械由国家药品监督管理部门审查，批准后发给医疗器械注册证。香港、澳门、台湾地区医疗器械的注册、备案，参照进口医疗器械办理。境内生产的医疗器械，应当由境内申请
16、人（备案人）申请注册或者办理备案。进口医疗器械，应当由境外申请人（备案人）作为注册申请人或者备案人，由其在我国境内设立的代表机构或者指定我国境内的企业法人作为代理人，申请注册或者办理备案。Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal
17、party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality l
18、ocated (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial polluti
19、on sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 mil
20、lion mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 milli
21、on acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves S
22、uper 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and
23、“three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight trans
24、port port, built on the border between China and Russia has the largest permanent boundary River Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavod
25、sk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, r
26、adiation in the CIS and Eastern European countries; to the South through the port of Vladivostok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery
27、of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Oriental Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi（4）医疗器械注册证格式与备案凭证格式医疗器械注册证格式由国家食品药品监督管理总局统一制定。注册证编号的编排方式为： X1 械注 X2XXXX3X4XX5XXXX6。其中：X1 为注册审批部门所在地的简称：境内第三类医疗器械、进口
28、第二类、第三类医疗器械为“国”字；境内第二类医疗器械为注册审批部门所在地省、自治区、直辖市简称；X2 为注册形式：“准”字适用于境内医疗器械；“进”字适用于进口医疗器械；“许”字适用于香港、澳门、台湾地区的医疗器械；XXXX3 为首次注册年份；X4 为产品管理类别；XX5 为产品分类编码；XXXX6 为首次注册流水号。延续注册的，XXXX3 和 XXXX6数字不变。产品管理类别调整的，应当重新编号。第一类医疗器械备案凭证编号的编排方式为： X1 械备 XXXX2XXXX3号。其中： X1 为备案部门所在地的简称：进口第一类医疗器械为“国”字；境内第一类医疗器械为备案部门所在地省、自治区、直辖市
29、简称加所在地设区的市级行政区域的简称（无相应设区的市级行政区域时，仅为省、自治区、直辖市的简称）；XXXX2 为备案年份；XXXX3 为备案流水号。（5）医疗器械说明书和标签管理医疗器械说明书是指由医疗器械注册人或者备案人制作，随产品提供给用户，涵盖该产品安全有效的基本信息，用以指导正确安装、调试、操作、使用、维护、保养的技术文件。医疗器械标签是指在医疗器械或者其包装上附有的用于识别产品特征和标明安全警示等信息的文字说明及图形、符号。医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致。医疗器械的说明书、标签应当标明下列事项：通用名称、型号、规格；生产企业的名称和住
30、所、生产地址及联系方式；产品技术要求的编号；生产日期和使用期限或者失效日期；产品性能、主要结构、适用范围；禁忌症、注意事项以及其他需要警示或者提示的内容；安装和使用说明或者图示；维护和保养方法，特殊储存条件、方法；产品技术要求规定应当标明的其他内容。第二类、第三类医疗器械还应当标明医疗器械注册证编号和医疗器械注册人的名称、地址及联系方式。Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural a
31、nd rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all t
32、he friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilo
33、meters of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“
34、Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing
35、grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more specie
36、s precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billio
37、n cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along th
38、e border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary River Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities
39、(Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail
40、and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivostok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism
41、 resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Oriental Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi3由消费者个人自行使用的医疗器械还应当具有安全使用的特别说明。医疗器械的产品名
42、称应当使用通用名称，通用名称应当符合国家食品药品监督管理总局制定的医疗器械命名规则。第二类、第三类医疗器械的产品名称应当与医疗器械注册证中的产品名称一致。医疗器械说明书和标签文字内容应当使用中文，中文的使用应当符合国家通用的语言文字规范。医疗器械说明书和标签可以附加其他文种，但应当以中文表述为准。医疗器械说明书和标签不得有下列内容：含有“疗效最佳”、“保证治愈”、“包治”、“根治”、“即刻见效”、“完全无毒副作用”等表示功效的断言或者保证的；含有“最高技术”、“最科学”、“最先进”、“最佳”等绝对化语言和表示的；说明治愈率或者有效率的；与其他企业产品的功效和安全性相比较的；含有“保险公司保险”
43、、“无效退款”等承诺性语言的；利用任何单位或者个人的名义、形象作证明或者推荐的；含有误导性说明，使人感到已经患某种疾病，或者使人误解不使用该医疗器械会患某种疾病或者加重病情的表述，以及其他虚假、夸大、误导性的内容；法律、法规规定禁止的其他内容。2. 医疗器械经营与使用管理（1）医疗器械经营分类管理 按照医疗器械风险程度，医疗器械经营实施分类管理。经营第一类医疗器械不需许可和备案，经营第二类医疗器械实行备案管理，经营第三类医疗器械实行许可管理。（2） 医疗器械经营许可证管理医疗器械经营许可证有效期为 5年。医疗器械经营许可证载明许可证编号、企业名称、法定代表人、企业负责人、住所、经营场所、经营方
44、式、经营范围、库房地址、发证部门、发证日期和有效期限等事项。医疗器械经营许可证有效期届满需要延续的，医疗器械经营企业应当在有效期届满 6个月前，向原发证部门提出医疗器械经营许可证延续申请。医疗器械经营许可证编号的编排方式为： XX 食药监械经营许 XXXXXXXX号。 其中：第一位 X代表许可部门所在地省、自治区、直辖市的简称；第二位 X代表所在地设区的市级行政区域的简称；第三到六位 X代表 4位数许可年份；第七到十位 X代表 4位数许可流水号。第二类医疗器械经营备案凭证备案编号的编排方式为： XX 食药监械经营备 XXXXXXXX号。 其中：第一位 X代表备案部门所在地省、自治区、直辖市的简
45、称；第二位 X代表所在地设区的市级行政区域的简称；第三到六位 X代表 4位数备案年份；第七到十位 X代表 4位数备案流水号。（3）经营质量管理规范的基本要求医疗器械经营质量管理规范是医疗器械经营质量管理的基本要求，由国家食品药品监督管理总局制定，适用于所有从事医疗器械经营活动的经营者。企业应当依据本规范建立和执行覆盖医疗器械经营全过程的质量管理制度，并采取有效的质量控制措施，保障经营过程中的质量安全。企业应当根据经营范围和经营规模建立相应的质量管理记录。企业应当建立并执行进货查验记录制度。Leaders: provincial agricultural work Conference held
46、 in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agricul
47、ture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered wi
48、th forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United N
49、ations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing
