Background

China has implemented additional inspection requirements for exports of medical supplies and non-medical supplies as part of its response to the COVID-19 pandemic. For example, exporters must present the manufacturer’s license to China Customs for medical supplies but not for non-medical supplies.

Because exporters can often be confused about how to differentiate these two categories, below are a few tips on how to mark and pack such goods to facilitate export clearance. These suggestions are applicable to all product description materials, including the product itself, inspection certificates, external and internal packaging, user manuals, etc., regardless of the language used.

- If the product description includes any wording indicating medical use, the product will be deemed a medical supply.

- The “FDA” mark indicates that the product is considered a medical supply.

- The European CE mark and the KN95 standard for face masks do not indicate medical use. (Relevant standards are EN149-2001 + A1:2009 (CE) and GB 2626-2006 (KN95).)

Note: if there are conflicting standards in the product description, the higher standard prevails. For example, if both FDA and CE are printed on the outside package, the product will be deemed a medical supply.

- The following are applicable to both medical and non-medical supplies: (1) the inspection label must include at least the product name, model, batch number, period of validity, production date, standard, material, and manufacturer information, and (2) the product should be packed in a way that is ready for resale (e.g., in a box, but not in bulk).

For more information or assistance exporting medical supplies from China, please contact Harry Zhang.

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