Why your PPE can’t leave China

With the world battling the coronavirus now, Personal Protective Equipment (PPE) is needed to contain and slow the spread of the virus. These products are needed in the market and the demand is higher than the supply. As many of you know, I have been working with China for over 15 years. They have become the “world’s factory” and a central manufacturing hub of many global business operations. Any disruption in China will affect the global market.

I have received countless phone calls, emails and messages these past six weeks from many of our customers if they can help us get their PPE products purchased from Company ABC out of China. Which leaves my customers wondering, why these suppliers are having a difficult time getting products out? There are tons of factories that manufacture your personal protective equipment, but why can't your PPE leave China? 

Due to the large worldwide demand or PPE, thousands of companies have popped up trying to manufacture/sell/trade sub-par products on this open market. This leads to many fake PPE products. Manufacturers and traders are taking advantage of the current situation. Getting greedy because of high demand in the worldwide market. If they have fake products then surely they have fake certificates. Fake certificates for PPE have increased in the past weeks. Manufacturers will make sure that their fake products will be exported with the use of fake certificates. If you are importing into Europe or America, you need registration with certain governmental bodies to import this product as well. In America, both the exporter/manufacturer and the importer need to be registered by the US Food & Drug Administration (FDA).

China is naturally afraid of losing face in the midst of this global pandemic. Last week Canada rejected 1-million China standard KN95 face masks. Several weeks ago Spain reported more than 70% faulty COVID-19 test kits and last week rejected China's rework. Every day, there are stories of how China is failing the world with their sub-par PPE but China is the major supplier of PPE. Chinese companies are popping up with little to no experience are making ventilators and hospital equipment. These "medical devices" are not even certified by China's own National Medical Products Administration (NMPA), where they are exported from, let alone certified in their own countries they are imported to.

Some of the PPE products that don't meet the standards are sent back to China - or worse, destroyed because the manufacturer did not have the proper certifications. The Chinese government is cracking down on manufacturers selling products not conforming even to basic domestic Chinese medical standards, let alone international standards. China’s laws have been constantly changing and are not uniformly applied across the country, China Customs and Export Control have been bocking shipments of your PPE orders and requiring the Chinese company exporter to obtain export approval. Manufacturers that met the national standards may apply for export approval. Most likely your trading Company ABC does not qualify.

Here's the current list (as of April 30, 2020) of how to get export documentation & approval. Below list courtesy of UPS, China Ministry of Commerce, China Customs. [links in Chinese]:

1. For the export of medical materials for legal inspection, enterprises need to fill in the purpose of use in the commodity name column of the declaration form and indicate whether it is medical, and the test reagent must indicate whether it is used for the detection of new coronavirus.
2. For the 5 types of medical materials listed in the Announcement No. 5 (including those listed in the subsequent adjustments of the announcement) for export of new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers, enterprises must provide written documents to the customs Or electronic declaration and China's medical device product registration certificate.
3. For other export medical materials listed in the Announcement No. 53, when the enterprise declares to the customs, it shall provide the medical device product registration/recording certificate and the export medical material declaration.
4. For new coronavirus testing reagents, the consignor should apply for health and quarantine approval, submit the inspection through a single-window based on the "Entry / Exit Special Articles for Health and Quarantine Approval Form", after passing the customs inspection, obtain the electronic fund account, fill in the electronic during customs Account number.
5. The export of medical materials should meet the requirements of the importing country (region). If there is no quality and safety standard required for the importing country (region), it should meet the quality and safety standards of China.

With the result of the newly issued regulations, thousands, even millions of facemasks and medical supplies are stranded or can’t leave China. This new regulation is not to restrict the export of medical kits, but to help improve the quality needed to help stop or contain the outbreak and ensure buyers are getting a legitimate product.

Due to coronavirus, much of our business operations have pivoted to selling personal protection products and other medical supplies. We deal directly with FDA-registered factories (and verify the factories we deal with also have certification from China). We directly and legally import the products into the USA with our FDA device registration, and through our Health Canada partners for Canadian customers. 

Our experience in China, along with being able to navigate the business environment in both countries, help our customers get their much-needed PPE “out the door”, so to speak. Digital Exports (our mainland Chinese company) is owned and operated by a group of Americans, looking out for our American and European buyers. Our no-nonsense, no-BS approach will make sure you get your PPE and medical products out of China and to your door.

TJ Weber is the General Manager of Digital Exports (www.digitalexports.com) and senior partner in Sourcery (www.sourcery.com). He has been working with China manufacturing for 15 years and navigating the complex inner workings of dealing with Chinese companies. He resides most of the year in Shenzhen China with his wife and children.