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The Chinese Ministry of Commerce (MOFCOM) and the Administration of Customs and States (SAMR) have jointly published a new decree (No. 12/2020) with effect on April 26 for quality control of medical items for export.

The new decree focuses on the management of face masks and medical devices not registered in China.


For the non-surgical face mask, the exporter must clearly prove the quality standards required to export the face masks:


- If the face masks follow China's quality standards, the exporter must check whether the manufacturer is on a SAMR company "blacklist" (can be found on the SAMR website)
-If in the "black list", the shipment cannot be exported.
-If it is not present in the "black list", the shipment can be accepted: exporter and importer must sign a joint declaration as a support document for the export customs declaration.
Facial masks follow the quality standards of the destination country, exporter must make sure that the manufacturer is in the "white list".
-If in the "white list", the shipment can be accepted: exporter and importer must sign a joint declaration as a supporting document for the export customs declaration.
-If it is not present in the "white list", the shipment cannot be exported.
For medical devices (COVID-19 test kit, ventilator, infrared thermometer, surgical / medical face mask, protective clothing), the exporter must ensure that the medical device is registered in China.
If the medical device is registered in China (FDA register) no impact from the new decree. The existing process is followed.

For medical device not registered in China FDA, exporter must verify if the manufacturer is included in the "white list"
If present in the "white list", the shipment can be accepted. The exporter must provide "Export declaration of medical supplies" as a support document for the export customs declaration.

If it is not present in the "white list", the shipment cannot be exported.
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