Declaration Items
(1) Whether there is a national approval document;
(2) Types and quantities of imported items;
(3) From which country or region;
(4) Consignor and destination.
Present Documents
(1) National approval document;
(2) Inspection report from the relevant national drug inspection authority.
Inspection Procedures
(1) Review the relevant national approval document;
(2) Review the inspection report from the drug inspection authority;
(3) Verify whether the batch number, origin, and quantity of imported items are consistent with the approval document and inspection report;
(4) Any small quantities of imported blood products without national approval shall not be allowed entry, except for personal use by foreign nationals, and shall be handled according to relevant regulations.
Sanitary Treatment
For large batches of imported blood products with national approval, HIV antibody testing may be conducted on a sampling basis. Any positive samples shall be sealed and reported to the Ministry of Health for further instructions.
Quarantine Process for Special Items
Special items (microorganisms, human tissues, biological products, blood and blood products, etc.) require prior application for health quarantine approval before entry. Application materials include: list of special items, statement of purpose, risk assessment report, certificate of origin, etc. They may enter only after passing customs quarantine. Special items not quarantined shall not be imported without authorization.
Entry-Exit Quarantine Process for Special Items
The quarantine process for special items (including microorganisms, human tissues, biological products, blood and blood products, etc.) must strictly follow these procedures:
- Approval Application — Submit an application for entry/exit approval of special items to customs (formerly inspection and quarantine authorities), providing information such as item name, origin, intended use, and safety level.
- Risk Assessment — Customs conducts a health quarantine risk assessment for special items to determine the risk level and supervisory requirements.
- Approval Decision — After the risk assessment is passed, customs issues a Entry/Exit Health Quarantine Approval Certificate for Special Items.
- On-Site Inspection — Upon arrival of the goods, customs conducts an on-site inspection to verify that the item name, quantity, packaging, etc., match the approval certificate.
- Release or Supervised Transport — Items are released after passing inspection; some high-risk items must be transported and used under customs supervision.
The entry and exit of special items must be handled by enterprises with appropriate qualifications. Violations of import/export regulations will result in severe penalties. It is recommended to engage an experienced customs broker for handling operations.
Bofeng Logistics specializes in providing one-stop logistics services including domestic container shipping (FCL/LCL in China), international sea freight (FCL/LCL), dedicated Hong Kong and Macau logistics routes, as well as trucking, customs declaration, and warehousing. Contact number: 130-7567-8958 (Manager Huang). Call now for a customized quotation!
Regulations on Special Items
The management of the entry and exit of special items is based on the Frontier Health and Quarantine Law of the People's Republic of China and its implementing regulations. Special items imported without quarantine approval will be detained or returned by customs in accordance with the law; serious cases will result in legal liability.
Bofeng Logistics can assist with the quarantine procedures for special items. Contact number: 130-7567-8958.
Examples of Common Special Items
Common special items requiring quarantine include: microbial strains for scientific research, human cells and genetic materials, reference standards and controls for diagnostics, raw materials for biopharmaceuticals, etc. The importation of these items requires prior access to health quarantine approval; import without approval is prohibited.
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