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Several Questions You Need to Know about Importing Face Masks from China

Author: Huang Mengjie

At this unusual moment towards a global public health crisis caused by the spreading COVID-19 pandemic, more and more overseas purchasers tend to import epidemic prevention and control supplies from China. In order to help overseas purchasers better know the export regulations for face masks in China, we will give some suggestions about how to choose a good supplier, what shall be agreed in the contract and what is the special Customs clearance requirements.

 

1.How to choose a good supplier?

a)  Check the lists

On March 31, 2020, the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration of China jointly issued the Announcement No.5 (2020) on Exporting Medical Supplies in Order (the “Announcement No.5”). The Announcement No.5 stipulates that, for the export of medical face masks, a medical device registration certificate approved by the National Medical Products Administration shall be obtained.

On April 25, 2020, the Ministry of Commerce, the General Administration of Customs and the State Administration for Market Regulation of China jointly issued the Announcement No.12 (2020) on Further Enhancing Quality Oversight for Exported Epidemic Prevention and Control Supplies (the “Announcement No.12”). The Announcement No.12 stipulates that, for exported non-surgical face masks, the Ministry of Commerce shall offer a list of validated non-medical use face mask manufacturers with certification or authorization from other countries; and the State Administration for Market Regulation shall offer a list of disqualified non-medical use face masks and manufacturers found on the Chinese market. The Announcement No.12 also stipulates that, for exported medical face masks, the Ministry of Commerce shall offer a list of manufacturers that have obtained certification or authorization from foreign countries.

Announcement Type List How to check
No.5 Medical Face Mask Medical Device Registration Information  See www.nmpa.gov.cn for updates
No.12 Non-surgical Face Mask Validated Non- medical Use face Mask Manufacturers with Certification or Authorization from Other Countries  See www.cccmhpie.org.cn for updates
No.12 Non-surgical Face Mask Disqualified Non-medical Use Face Masks and Manufacturers Found on the Chinese Market  See www.samr.gov.cn for updates
No.12 Medical Face Mask Manufacturers That Have Obtained Certification or Authorization from Foreign Countries  See www.cccmhpie.org.cn for updates

 

 

Lists provided by the Announcement No.5 and Announcement No.12

 

If overseas purchasers intend to purchase medical face masks from China, it is necessary to make sure that a medical device registration certificate approved by the National Medical Products Administration has been obtained and the supplier is on the list of manufacturers that have obtained certification or authorization from foreign countries offered by the Ministry of Commerce.

If overseas purchasers intend to purchase non-surgical face masks from China, it is highly recommended to choose a supplier not on the list of disqualified non-medical use face masks and manufacturers found on the Chinese market offered by the State Administration for Market Regulation, which will make it easier to be released by the customs. Provided that a supplier is on the list of disqualified non-medical use face masks and manufacturers found on the Chinese market, its products will be the focus of inspection of the customs.

 

b)  Check the supplier’s qualification

After preliminary selection of suppliers, it is important to check the following materials of Chinese export companies or face mask manufacturers:

a)Business License (to check the business scope)

b)Production License

c)Product Inspection Report

d)Medical Device Registration Certificate of medical face mask

e)Product specification and Label 

f)Product Batch Number

g)Product Certificate

h)Pictures of sample and packing

i)Registration of consignee or consignor at the customs

 

c)  Make sure that face masks meet the entry conditions of importing countries

When choosing Chinese supplier, overseas purchasers shall confirm with the supplier that the face masks meet the entry conditions of importing countries. For example, if the importing country is a member of EU, for non-surgical face masks, the European standard is EN149 and non-surgical face masks are classified into three categories (FFP1, FFP2 and FFP3). For medical face masks, the European standard is EN14683. All face masks exported to EU shall obtain the CE Certificate.

 

2.What shall be agreed in the contract?

a)  Quality Terms

It is highly recommended to agree on the supplier’s export qualification, the entry conditions of importing countries and the inspection institution approved by both parties.

 

b)  Trade Terms

To ensure the supplier be responsible for export customs clearance in China, trade terms like FCA (free carrier) shall be applied and trade terms like EXW (Ex Works) shall be avoided.

 

c)  Payment Terms

In consideration of the current COVID-19 epidemic and the uncertainty of international trade, we suggest overseas purchasers make the payment by L/C or only make some advance payment first and pay the rest amount after the customs clearance is completed and the face masks are shipped.

 

3.What is the special customs clearance requirements of face masks?

a)  Export customs clearance in China

Because Chinese suppliers are more familiar with Chinese customs regulations than overseas purchasers, we highly recommend that the supplier shall bear the responsibility of export customs clearance in China. However, if overseas purchasers have to be responsible for the export customs clearance, we will introduce the special customs Clearance requirements of face masks as follows:

 

i.Non-surgical Face Mask

A joint declaration of the exporter and the importer provided by the Announcement No.12 together with customs declarations shall be submitted, as a confirmation that the face masks are compliant with the quality standards of China or other countries, and that the importer accepts the quality standards of the face masks purchased and does not use them for medical purposes. The customs shall inspect and release face masks according to the list of validated non-medical use face mask manufacturers with certification or authorization from other countries offered by the Ministry of Commerce. For face masks from manufacturers not included in the list of disqualified non-medical use face masks and manufacturers found on the Chinese market offered by the State Administration of Market Regulation, the customs shall accept the declarations, and inspect and release the face masks; for face masks from manufacturers included in the list of disqualified non-medical use face masks and manufacturers found on the Chinese market, these face masks will be the focus of inspection of the customs.

 

ii.Medical Face Mask

A declaration regarding to exporting medical supplies provided by the Announcement No.5 shall be submitted, as a commitment that a medical device registration certificate has been obtained and the face masks meet the quality standards of importing countries. The customs shall inspect and release face masks according to the medical device registration certificate approved by the National Medical Products Administration.

For face masks only getting certified or registered according to foreign standards, the customs shall inspect and release according to the list of manufacturers that have obtained certification or authorization from foreign countries offered by the Ministry of Commerce together with a joint declaration of the exporter and the importer provided by the Announcement No.12 as a confirmation that the face masks are compliant with the quality standards and safety requirements of importing countries

 

At present, the inspection rate of epidemic prevention and control supplies such as face masks is relatively high at all ports. The overseas purchasers and Chinese suppliers shall truthfully report the brand, type, quantity, purpose and other basic information of face masks to the customs.

 

b)  Import customs clearance in importing countries

Before the face masks are shipped or even before the contract is signed, the overseas purchaser shall confirm with the customs of importing counties about what materials shall be submitted and what requirements shall be met to avoid the risk of failure to complete import customs clearance.

 

 

China has provided strong support to the international community in global fight against the COVID-19 pandemic, with its daily export of anti-epidemic supplies over the past few months. As part of the efforts to strengthen quality control over exports of medical supplies, China has intensified crackdown on exports of counterfeit and shoddy products and other behaviors that disrupt the market and export order. We hope this article can help overseas purchasers understand and follow the export regulations for face masks in China.

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