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According to the Supplementary Provisions of Chapter VIII of the Regulations on the Supervision and Administration of Medical Devices (the State Council Order No.650 of the People's Republic of China), the definition of medical devices refers to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in the human body, including the required computer software.
The customs has continuously found that imported oral scanners, X-ray tube assemblies, lower limb rehabilitation training machines, disposable sterile syringes, root canal preparation machines and other medical devices have no medical device registration certificates. According to the law, the customs determines that the above-mentioned goods are unqualified and returns them.
According to the definition of the Law on Safety of Special Equipment, special equipment refers to boilers, pressure vessels (including gas cylinders), pressure pipes, elevators, lifting machinery, passenger ropeways, large amusement facilities, special motor vehicles in yards (factories) (hereinafter referred to as "field vehicles") and other special equipment to which the Law on Safety of Special Equipment applies according to laws and administrative regulations.
进口企业所必须具备的资质： The qualifications that an importing enterprise must possess: 1. Import and export operation rights; 2. Business license (there is a license to sell medical devices within the business scope); 3. Medical device registration certificate; 4, medical device business license. Documents to be provided for medical devices/equipment: 1、进出口经营权； 2、营业执照（经营范围里有销售医疗器械许可）； 3、医疗器械注册证； 4、医疗器械经营许可证。 医疗器械/设备时需要提供的文件：
When second-hand machinery and equipment are exported to Vietnam, it is necessary to prepare relevant materials in accordance with the regulations of the Vietnamese government in addition to the conventional materials for the export of second-hand equipment. According to Vietnamese government decision No.18/2019/QD-TTG, it is prohibited to import second-hand machinery, equipment and production line technology with a technical service life of 10 years or more, which took effect on June 15, 2019.
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