As the world looks to China to provide medical supplies for dealing with the Covid-19 emergency, a series of problems have emerged. In Europe, huge quantities of Chinese coronavirus test kits and medical use masks have been rejected as defective. All of this has damaged the reputation of China and Chinese manufacturers.
In response to this situation, the Chinese authorities issued an Order that tightly regulates the export of coronavirus medical devices and supplies from China. Under this Order, any Chinese exporter of listed medical devices must meet two requirements. First, the device must be registered in China through a Medical Device Product Registration Certificate. Second, the exporter must prove that the device complies with the regulations of the importing country.
Compliance with these requirements resulted to be difficult for many Chinese manufacturers.
The Order, jointly announced by the Ministry of Commerce, the Customs Bureau and the National Medical Products Administration, started being effective from April 1st, 2020. The Order is temporary and can be expanded or revoked at any time.
The Order applies to the export of the following medical supplies:
1. Novel Coronavirus Test Kits
2. Medical Use Face Masks
3. Medical Use Protective Clothing
5. Infrared External Thermometers
For the listed products, the exporter must meet the two requirements mentioned above.
The Chinese exporter is also required to submit a signed form to China customs stating the required information and affirming its accuracy. Exporting under an inaccurate or falsified statement subjects the exporter to liability under Chinese law.
This Order raises important issues. Most Chinese manufacturers that manufacture medical devices for export do not bother to obtain a domestic Chinese registration. Since they manufacture exclusively for export, no such certification was ever required for their business and so they do not have one. This means that most Chinese exporters of PPE and medical devices cannot comply with this Order.
In addition, eight days later, with foreign complaints about defective Chinese medical supplies increasing, China Customs issued another annocement (Announcement 53) stating that from the beginning of April 10th, China Customs will be “examining for quality” medical supplies related to a list of 11 items, 6 more then the previous Order.
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