"In accordance with continuous measures to control the quality of export medical goods, the China Ministry of Commerce (MOFCOM), Customs and State Administration for Market Regulation (SAMR) jointly published a new decree (No.12/2020) on Apr 25th and has taken effect in Apr 26th. The new decree focuses on the management of non-medical face masks and medical devices not registered in China FDA.
For non-medical face mask, the exporter needs to clearly understand the quality standards of the face masks to be exported:
1. If face masks follow China quality standards, exporter needs to check if the manufacturer is under the SAMR enterprise “black list” (refer to the SAMR website):
a) If in the “black list”, shipment can’t be exported.
b) If not in the “black list”, shipment can be exported. CN exporter and importer at destination country need to sign a joint declaration (Attachment 1) as supporting document for export customs declaration.
2. Face masks will follow the destination country’s quality standards. Exporter needs to ensure the manufacturer is under the MOFCOM “Face mask white list” (Attachment 3)
a) If in the “white list”, shipment can be exported. CN exporter and importer at destination country need to sign a joint declaration (Attachment 1) as supporting document for export customs declaration.
b) If not in the “white list”, shipment can’t be exported.
For medical devices. (I.e. COVID-19 test kits, ventilators, infrared thermometers, surgical/medical face masks, medical protective clothing), exporter needs to know if these medical devices are registered in China FDA:
1. For medical devices registered in China FDA, no impact from the new decree. Just following existing process.
2. For medical devices not registered in China FDA, exporter needs to check if the manufacture is under the MOFCOM “medical device white list” (Attachment 4)
a) If in the “white list”, shipment can be exported. CN exporter needs to provide an “Export declaration of medical supplies” (Attachment 2) as supporting document for export customs declaration.
b) If not in the “white list”, shipment can’t be exported.
Chinese government came out with 3 new policies in 30 days to regulate the quality of export medical devices. It shows the great concern and focus in this area. As the border agency, customs has put in place safeguards to check the declaration paperwork and inspect the physical goods. We have seen a huge volume of shipments held in customs due to low quality of clearance paperwork from shippers. Paperwork quality issue not only slows down the whole process, but also increases the potential customs compliance risks to DHL. From an operational perspective, it’s impossible to have our couriers remember all of these new paperwork requirements considering the dynamic changes of customs policies. As a solution, DHL CN has started shipping pre-check documents for medical goods to ensure shipments are good for customs clearance. Shipper provides the clearance paperwork to DHL in advance. DHL courier will pick up the shipment when the paperwork passed the pre-check process.
Here’s the process in detail:
- Customer sends all necessary customs declaration paperwork (image and forms) to the dedicated DHL mail address.
- CN HUB/GTW clearance team evaluates all the paperwork and provides the assessment feedback to customers by an email response. If paperwork is fine for export declaration, a QR code is sent out to the customers in the same email response. (If paperwork found non-compliant with customs requirements, the customer will be notified by the email response about the potential issues, no pick-up is accepted.)
- Customers may book and schedule pickup by couriers upon receiving the QR code and an notice of receipt. Couriers complete the pick-up and scan the QR code.
According to China customs’ newly published export requirements for COVID-19 related medical goods, including COVID-19 test kits, ventilators, surgical/medical face masks, infrared thermometers, starting Apr 1st, shipper needs to provide additional documents for export customs declaration:
1. Self-declaration (Customs standard word file format) with the following information:
a. Product name
b. Quantity
c. China FDA registration number
d. Destination country quality standards, such as EN 142-2001 for EU
e. Batch number of the product
f. Destination country
g. Manufacturer name
2. Copy of medical devices’ registration certificate or screen shot of registration information from China FDA website.
Please inform customers to double check with their suppliers in China to ensure the medical goods they ordered are in the “medical device list” (updated in Mar 31st) as attached Excel file or log into the China FDA website to check: http://qy1.sfda.gov.cn
As the further measures to ensure the quality of export medical goods, China customs published a new announcement (No.53/2020) in Apr 10th and took effect on the same day. According to the announcement, all of the following medical goods must meet national quality standards, for which additional export clearance paperwork is required and customs will impose a 100% inspection on:
COVID-19 test kits, ventilators, infrared thermometers, surgical/medical face masks, medical protective clothing, medical/surgical hats, medical goggles, medical/surgical gloves, medical shoes cover, patient monitoring devices, disinfectant towels, and disinfectants. The direct impact of the new regulation on medical shippers in China are:
1. No impact for shipment sent from private individual to private individual, value limit is at RMB 1000
2. All medical goods mentioned above for shipping from business to business or business to consumer must be declared as formal entry and must provide the following documents in addition to standard shipping paperwork (AWB, invoice, packing list, sale contract, POA).
a. Company statement for the export of medical material (chopped copy)
b. Registration form of medical devices manufacturing (chopped copy)
c. Screenshot from China FDA website for registered manufacturer/product
d. Quality Assurance (QA) tag for the product by the manufacturer (accompanying the physical product)
e. Manufacture permit for medical device (nice to have, may help faster clearance)
f. Copy of business license from the manufacturer (nice to have, may help faster clearance)
g. Test report from the manufacturer (nice to have, may help faster clearance)
3. Masks, protective clothing, gloves, goggles etc. that manufactured for non-medical purpose need not provide medical certificates for export clearance.
However, these will all be physically inspected by customs. Any medical material declared as non-medical and are not able to provide further medical certificates,
will be detained and penalized by customs. If words like “medical”, “surgical” are shown on the product, these will be deemed medical goods regardless of usage.
To ensure compliance to the new regulations, for DHL as an export clearance broker and also to avoid further increase of on-hold OB volume due to customs detainment mentioned above at CN hub/gateway, China couriers will strictly verify the medical commodity against non-medical at the time of pickup, and ensure full paperwork required for medical shipments are available before accepting medical related shipments.
Category B:
personal effects, valued less than 1000 CNY (Destination HK, MO, TW, 800 CNY)
Paperwork needed:Waybill, Invoice, Shipper's citizen ID card
Category C:
shipment valued for less than 5000 CNY, content doesn't under customs control and doesn't require any license.
Paperwork needed:
Waybill, Invoice
Category D:
shipment valued higher than 5000 CNY or required business license or content under CN customs control.
Paperwork needed:
- Formal declaration form provided by EOR with their CN Customs registration number.
- Waybill, commercial invoice, packing list, POA, contract.
- To provide business license for medical equipment and other documents required by CN Customs.
