China Customs General Administration Bulletin No. 53 of Export Inspection of Medical

Issued on 23 Apr 20

China Customs General Administration Bulletin No. 53 (WEF 10 Apr 20) of Export Inspection of Medical Materials Export inspection situation: a. Implement 100% document review and seizure

b. 100% inspection (internal and external packaging, color appearance, production, shelf life, certification audit, etc., Prevent unqualified products such as "3 None" and pollution deterioration (3 None: None of the manufacturers, None of the implementation standards, None of the expiration date). c. Brand review to prevent secondary risks such as intellectual property infringement d. Strengthen the audit of FDA, CE, and other certification certificates to ensure that the certificates are accurate and meet the product's declaration standards.

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f. Indicate whether it is medical, and the test reagent must indicate whether it is used for the detection of new coronavirus. Note: If there are both medical materials and non-medical materials under the same HS code, it should be determined whether it is medical according to the characteristics of the product itself, that is, the manufacturing standards and specification. g. For the export of new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers, 5 types of medical materials, must provide a written or electronic statement and China Medical Device Product Registration Certificate. The new crown virus detection reagent must also provide the export sales certificate issued by the drug regulatory department.

h. Provide medical device product registration, record registration certificate and quality and safety commitment statement when customs declaration.

i. For new coronavirus testing reagents, the consignor should apply for health and quarantine approval, submit the inspection through a single-window based on the "Entry / Exit Special Articles for Health and Quarantine Approval Form", after passing the customs inspection, obtain an electronic account, and fill in the electronic account during customs Account number.

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