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| Provisions of the Customs of the People's Republic of China on the Administration of Health and Quarantine for Special Goods and Articles Entering and Exiting China | | 中华人民共和国海关进出境特殊货物物品卫生检疫管理规定 |
| (Issued by Order No. 281 of the General Administration of Customs on January 6, 2026; taking effect on August 1, 2026) | | （2026年1月6日海关总署令第281号公布 自2026年8月1日起施行） |
| Chapter I General Provisions | | 第一章 总则 |
| Article 1 These Provisions are formulated in accordance with the Frontier Health and Quarantine Law of the People's Republic of China and the detailed rules for its implementation, the Biosecurity Law of the People's Republic of China, the Regulation on the Prevention and Treatment of HIV/AIDS, the Regulation on the Bio-safety Management of Pathogenic Microbe Labs, and other laws and administrative regulations for the purposes of regulating the supervision and administration of health quarantine for special goods and articles entering and exiting China, preventing the cross-border transmission of infectious diseases, safeguarding the life and health of the public, and preventing and mitigating public health risks. | | 第一条 为了规范进出境特殊货物、物品卫生检疫监督管理，防止传染病跨境传播，保障公众生命安全和身体健康，防范和化解公共卫生风险，根据《中华人民共和国国境卫生检疫法》及其实施细则、《中华人民共和国生物安全法》、《艾滋病防治条例》和《病原微生物实验室生物安全管理条例》等法律、行政法规，制定本规定。 |
| Article 2 These Provisions apply to the supervision and administration of health quarantine for special goods and articles entering and exiting China that are related to public health safety, including human tissues such as blood, pathogenic microorganisms, and biological products, excluding those regulated as pharmaceuticals, veterinary drugs, or medical devices. | | 第二条 本规定适用于血液等人体组织、病原微生物、生物制品等关系公共卫生安全的特殊货物、物品（纳入药品、兽药、医疗器械管理的除外）进出境卫生检疫监督管理。 |
| Article 3 The General Administration of Customs shall be responsible for the unified administration and supervision of health quarantine for special goods and articles entering and exiting China; the competent Customs offices shall be responsible, within their respective jurisdictions, for the administration and supervision of health quarantine for special goods and articles entering and exiting China. | | 第三条 海关总署统一管理全国进出境特殊货物、物品卫生检疫监督管理工作；主管海关负责所辖地区进出境特殊货物、物品卫生检疫监督管理工作。 |
| Article 4 The supervision and administration of health quarantine for special goods and articles entering and exiting China shall be conducted in accordance with the principle of risk management and, on the basis of risk assessment, be subject to health quarantine approval, quarantine inspection, and supervision according to the resulting risk levels. | | 第四条 进出境特殊货物、物品卫生检疫监督管理遵循风险管理原则，在风险评估的基础上根据风险等级实施卫生检疫审批、检疫查验和监督管理。 |
| The risk levels of special goods and articles entering and exiting China and the corresponding health quarantine regulatory approaches shall be dynamically adjusted and published by the General Administration of Customs. | | 进出境特殊货物、物品的风险等级及其对应的卫生检疫监管方式由海关总署动态调整并公布。 |
| Article 5 The General Administration of Customs shall apply health quarantine access control to high-risk special goods and articles entering China for the first time or resuming entry following a suspension. The specific requirements shall be prescribed separately by the General Administration of Customs. | | 第五条 海关总署对首次进境或者暂停后恢复进境的高风险特殊货物、物品实施卫生检疫准入管理，具体要求由海关总署另行规定。 |
| Article 6 An entity engaged in activities involving special goods and articles entering or exiting China, or a consignor, a consignee, a sender or recipient, a person carrying such goods and articles, a carrier, or an agent of any of the foregoing, shall, when engaging in the importation, exportation, production, sale, or use of special goods and articles, comply with the requirements of laws and regulations and relevant standards, be responsible to society and the public, ensure the safety of special goods and articles, accept public supervision, and assume social responsibility. | | 第六条 进出境特殊货物、物品单位和进出境特殊货物、物品的收发货人、收寄件人、携运人（携带人）、承运人或者其代理人，应当按照法律法规规定和相关标准的要求，输入、输出以及生产、销售、使用特殊货物、物品，对社会和公众负责，保证特殊货物、物品安全，接受社会监督，承担社会责任。 |
| Chapter II Approval of Health Quarantine Matters | | 第二章 卫生检疫审批 |
| Article 7 Customs offices directly under the General Administration of Customs shall be responsible, within their respective jurisdictions, for the health quarantine approval of special goods and articles entering and exiting China ("approval of special goods and articles"). | | 第七条 直属海关负责辖区内进出境特殊货物、物品卫生检疫审批（以下简称特殊货物、物品审批）工作。 |
| Article 8 An applicant for the approval of special goods and articles shall satisfy the following conditions: | | 第八条 申请特殊货物、物品审批应当具备下列条件： |
| (1) Where laws and regulations require approvals from relevant departments, the applicant shall have obtained the required approvals. | | （一）法律法规规定须获得相关部门批准文件的，应当获得相应批准文件； |
| (2) The applicant shall possess biosafety control capacity commensurate with the special goods and articles entering and exiting China. | | （二）具备与进出境特殊货物、物品相适应的生物安全控制能力。 |
| Article 9 An entity or natural person engaged in activities involving special goods and articles entering or exiting China (collectively, "applicant") shall, before the commencement of shipment of such special goods and articles, apply for approval to the Customs office directly under the General Administration of Customs at the place where the applicant is located. | | 第九条 进出境特殊货物、物品单位或者自然人（以下统称申请人）应当在其特殊货物、物品启运前向申请人所在地直属海关申请审批。 |
| Article 10 An applicant applying for the approval of special goods and articles shall, in accordance with the applicable provisions, submit the following relevant materials: | | 第十条 申请特殊货物、物品审批的，申请人应当按照规定提供下列相应材料： |
| (1) An application form for the approval of special goods and articles. | | （一）特殊货物、物品审批申请表； |
| (2) Descriptive materials for special goods and articles entering and exiting China (including their Chinese and English names, categories, components, sources, manufacturing processes, intended uses, intended distribution, countries or regions of export and import, manufacturers, and other relevant information), product safety supporting materials, and biosafety risk self-assessment materials. | | （二）进出境特殊货物、物品描述性材料（包括中英文名称、类别、成分、来源、生产工艺、用途、流向、输出输入的国家或者地区、生产商等），产品安全性证明材料，生物安全风险自评情况等； |
| (3) Where special goods and articles entering and exiting China contain or may contain pathogenic microorganisms, supporting documents shall be provided specifying the scientific names of the pathogenic microorganisms (in Chinese, English, or Latin, as applicable), explanatory documents on their biological characteristics (in both Chinese and English), and supporting documents evidencing the corresponding biosafety control levels. | | （三）进出境特殊货物、物品含有或者可能含有病原微生物的，应当提供病原微生物的学名（中文、英文或者拉丁文）、生物学特性的说明性文件（中英文对照件）以及具备相应生物安全防控水平的证明文件； |
| (4) Where an entity using special goods and articles entering and exiting China that contain or may contain pathogenic microorganisms conducts pathogenic microorganism experimental activities in biosafety level 1 or level 2 laboratories, the laboratory filing materials filed with the health department of a people's government at the districted city level shall be provided; where such experimental activities are conducted in biosafety level 3 or level 4 laboratories, supporting documents evidencing approval of experimental activities involving highly pathogenic microorganisms by the health departments of the people's government at or above the provincial level shall be provided. | | （四）使用含有或者可能含有病原微生物的进出境特殊货物、物品单位，病原微生物实验活动在一级、二级病原微生物实验室开展的，应当提供经设区的市级人民政府卫生健康主管部门备案的实验室备案相关材料；病原微生物实验活动在三级、四级病原微生物实验室开展的，应当提供由省级以上人民政府卫生健康主管部门批准的高致病性病原微生物实验活动相关证明文件； |
| (5) Where highly pathogenic microorganism strains or samples entering or exiting China are involved, transport-related supporting documents approved by the health departments of the people's government at or above the provincial level shall be provided. | | （五）进出境高致病性病原微生物菌（毒）种或者样本的，应当提供省级以上人民政府卫生健康主管部门批准的运输相关证明材料。 |
| Article 11 Where the applicant is an entity, upon applying for the approval of special goods and articles for the first time, the applicant shall, in addition to the materials specified in Article 10, submit the following materials as required by the Customs: | | 第十一条 申请人为单位的，首次申请特殊货物、物品审批时，除本规定第十条所列明的材料以外，还应当根据海关要求提供下列材料： |
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