China Export Regulations: PPE & Medical Devices

The China Ministry of Commerce (MOFCOM), and the Customs and State Administration for Market Regulation (SAMR) jointly published a new decree on April 25th to control the quality of exported medical goods. The new decree focuses on the management of non-medical face masks and medical devices not registered in China FDA.

China shippers, exporters, vendors, suppliers must prepare all the required, compliant paperwork for all PPE or medical devices to be able to export them out of China. Other than assistance with the DHL air waybill and Commercial Invoice, It is not possible for either you or for Preferred Shipping customer service to complete the required China origin paperwork. It must be handled in China.

NON MEDICAL FACE MASKS
China exporters must understand the quality standards of face masks to be exported.

  1. If face masks follow China quality standards, exporter needs to check if the manufacturer is in SAMR enterprise “blacklist” Click here to access the SAMR enterprise blacklist.
    • If the manufacturer is in the blacklist, shipment can not be exported.
    • If the manufacturer is not listed in the blacklist, shipments can be accepted. The CN exporter and importer need to sign a joint declaration form as a supporting document for export customs declaration at the destination.
  2. If face masks follow the destination country quality standards, the exporter needs to ensure the manufacturer is in MOFCOM’s face mask whitelist. Click here to access MOFCOM’s face mask whitelist.
    • If the manufacturer is in the whitelist, the shipment can be accepted. At destination, the CN exporter and importer need to sign a joint declaration form as supporting document for export customs declaration.
    • If the manufacturer is not in the whitelist, the shipment can not be exported.

MEDICAL PPE, MEDICAL DEVICES
China exporters must understand if medical devices are registered in China FDA. Shipments that include COVID-19 test kits, ventilators, infrared thermometers, surgical/medical face masks, or medical protective cloth are included in this order. Please read the regulations outlined below for more information:

  • For medical devices registered in China FDA, there are no updates. Please follow existing processes.
  • For medical device not registered in China FDA, exporter needs to check if the manufacture is in MOFCOM’s medical device whitelist. Click here to access MOFCOM’s medical device whitelist.
  • If medical device is listed in MOFCOM’s whitelist, the shipment can be accepted. The CN exporter will need to provide a Export Declaration of Medical Supplies form as supporting document for export customs declaration.
  • If the medical device is not listed in the whitelist, the shipment can not be exported.

This is a constantly evolving situation, and we encourage you to keep in close contact with our customer service team as updates are made available.

DHL CN Pick Up Regulations
Due to the constantly changing requirements surrounding shipments containing medical devices and medical PPE, DHL CN created pre-check process to ensure that medical goods are accepted and will clear customs. The new pickup process steps are listed below:

  1. Shipper, Exporter calls DHL (CN) Customer Service and asks for dedicated pre-check DHL email address.
  2. Customer sends all necessary customs declaration paperwork (image and forms) to the dedicated DHL email address.
  3. CN HUB/GTW clearance team evaluates all paperwork and provides the assessment feedback to the Shipper, Exporter by email response.
    • If paperwork is fine for export declaration, a QR code is sent to the Shipper, Exporter via email.
    • If paperwork found non-compliance with customs requirements, the customer will be notified via email. No pick-up is accepted.
  4. Customers may then schedule pickup by providing the QR code.
  5. Drivers, Couriers complete the pick-up and scan the QR code.

DHL Network Weight Limit in Effect
DHL Express has implemented weight restrictions to all shipments originating in the Asia Pacific Region. Shipments will be limited to 70kgs per piece and 300kgs per shipment for multi piece shipments.

DHL has reopened the Heavyweight Spot Rate Program for import shipments originating in the Asia Pacific Region. The new weight restriction above applies to all Asia Pacific Region  Import quotes.


Important Links and Numbers

1.     DHL COVID-19 Temporary Service Adjustments: This link is updated almost daily with changes.

2.     Global Spot Rates: An alternative to traditional air freight, consider getting a global sport rate quote from your account representative.

3.     Preferred Shipping customer service: Call 1-800-827-7987 or email customerservice@preferredship.com