牙科医疗器械设备广州进口报关清关的文件单证
进口牙科医疗设备前，需要提前了解哪些东西。
一、进口报关需要的清关资料：
1、进口器械注册证和经营许可证；
2、若是进口含有药试剂成分的器械，需提供中国强制性认证证书（特殊物品审批单）；
3、部分器械进口需提供自动进口许可证；
4、提供进口牙科医疗设备的照片、铭牌、器械技术参数、终用途、中文说明书等；
5、牙科医疗设备进口合同、装箱单、发票、其他牙科医疗设备进口需补充说明的单证资料。
二、进口的流程思路：
1、确认进口产品医疗器械备案是否完成；
2、进口港口城市海关牙科医疗设备报关清关政策（选择口岸）；
3、确认订单国外发货；
4、整理牙科医疗设备清关资料；
5、牙科医疗设备到港申报；
6、目的地做调离。
牙科医疗器械设备广州进口报关清关的文件单证
第五条国家对医疗器械实行分类管理。第一类是指，通过常规管理足以保证其安全性、有效性的医疗器械。第二类是指，对其安全性、有效性应当加以控制的医疗器械。第三类是指,植入人体;用于支持、维持生命;对人体具有潜在危险,对其安全性、有效性必须严格控制的医疗器械。医疗器械分类目录由国务院药品监督管理部门依据医疗器械分类规则,商国务院卫生行政部门制定、调整、公布。第六条生产和使用以提供具体量值为目的的医疗器械,应当符合计量法的规定。具体产品目录由国务院药品监督管理部门会同国务院计量行政管理部门制定并公布。第二章医疗器械的管理第七条国家鼓励研制医疗器械新产品。医疗器械新产品,是指guoneishichang尚未出现过的或者安全性、有效性及产品机理未得到国内认可的全新的品种。第二类、第三类医疗器械新产品的临床试用,应当按照国务院药品监督管理部门的规定,经批准后进行。Article 5 The State shall exercise classified control over medical devices.The first category refers to medical devices that are sufficient to ensure their safety and effectiveness through routine management.The second category refers to medical devices whose safety and effectiveness should be controlled.The third category is implant; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.The classification list of medical devices shall be formulated, adjusted and published by the drug regulatory department under The State Council in consultation with the health administrative department under The State Council in accordance with the rules for the classification of medical devices.Article 6 The production and use of medical devices for the purpose of providing specific quantities shall comply with the provisions of the Metrology Law. The specific product catalogue shall be formulated and published by the drug regulatory department under The State Council jointly with the metrological administrative department under The State Council.Chapter II Management of medical devicesArticle 7 The State encourages the development of new products of medical devices. New medical device products refer to new varieties that have not yet appeared in the domestic market or whose safety, effectiveness and product mechanism have not been recognized in the country.The clinical trial of new products of Class II and Class III medical devices shall be conducted after approval in accordance with the provisions of the drug regulatory department under The State Council.
牙科医疗器械设备广州进口报关清关的文件单证
