First, the export declaration of the new coronavirus test kit must apply for the medical device registration certificate in China. The State Drug Administration determines the management category of the new coronavirus test kit in the third class of medical devices. Therefore, the production unit needs to obtain the Medical Device Production License, and the novel coronavirus test kit must obtain the Medical Device Registration Certificate of the People's Republic of China. For the export of the product of foreign trade business units must obtain the Medical device license. When the export inspection and quarantine is carried out, the Certificate of Export Sales of Medical Device Products shall be obtained from the Food and Drug Administration.
The export declaration of the novel coronavirus test kit shall apply to the Customs for the approval of export special goods
1, special goods supervision category biological products table
2, the exporter through the Customs entry and exit special goods health quarantine supervision system (Customs entry and exit special goods health quarantine supervision platform) to the factory directly under the customs application. Health quarantine supervision system
3. Documents 3.1, Application Form for Examination and Approval of Entry/Exit Health Quarantine for Special Goods 3.2, descriptive materials of exit special goods are required. Including the Chinese and English names, categories, ingredients, sources, uses of special goods, main sales channels, export countries or regions, distributors, etc. 3.3 Biological products and human blood products for the prevention, diagnosis and treatment of human diseases abroad shall provide a sales certificate issued by the drug regulatory department
Third, the new coronavirus test kit for export inspection and quarantine
1. Time and place of export inspection and quarantine
2. Export novel coronavirus test kits must be submitted for inspection 7 days before export declaration or shipment.
3. In principle, the place of declaration should apply to the customs of the location of the kit factory for exit inspection and quarantine procedures. After passing the inspection, the customs will issue an electronic ledger for export inspection and quarantine.
4. Documents required for exit declaration
5, foreign trade contracts, letters of credit, invoices, packing lists and other necessary documents
6. The outbound goods shall pass the inspection by the producer or business operator and attach the inspection and quarantine certificate or test report
7. After completing the above documents and obtaining the electronic account issued by the customs, the enterprise can prepare export documents to the customs for export declaration procedures.
Special reminder: the export inspection and quarantine of medical device enterprises shall ensure that the medical devices exported meet the requirements of the importing country (region).
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