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10 april 2020

Want to buy medical equipment, face masks or other PPE from China? Just be careful out there!

We have noticed that a lot of companies are trying to buy medical equipment like face masks and other PPE products from China. The main reason of course isthe current shortage due to the COVID-19 virus.

Of course, when buying from a foreign country you always have to ask yourself questions, like How can I be sure the foreign supplier can deliver the quality I need? and Is it legal for the foreign supplier to sell this product, meaning it has the necessary government approvals?

However, when buying medical equipment from China these days you have to be extra careful and if you are not an experienced buyer of medical equipment you definitely need professional advice.

New order on the export of medical devices

The Chinese government has reacted to the stories in the news about the delivery of defective masks, non-delivery after payment and receiving counterfeit masks quickly. It has issued an order with very strict rules on the export of medical devices and supplies from China. In short, the devices must have a Medical Device Product Registration Certificate in China and the exporter must be able to prove that the devices are compliant with the rules of the importing country.

Now in more detail. The order was issued effective April 1, 2020 jointly by the Ministry of Commerce, the Customs Bureau and the National Medical Products Administration. It is a temporary order and can be expanded or revoked at any time. The Order regulates the export of the following medical supplies:

  1. 1. Novel Coronavirus Test Kits 新型冠状病毒检测试剂.
  2. 2. Medical Use Face Masks 医用口罩.
  3. 3. Medical Use Protective Clothing 医用防护服.
  4. 4. Ventilators 呼吸机.
  5. 5. Infrared External Thermometers 红外体温计.

Further requirements

According to the Order, the exporting company must register the device in China obtaining a Chinese Medical Device Product Registration Certificate. When exporting the Chinese company must provide the registration number for the product/device as a requirement for export. The Order provides as an annex a list ofall entities that have obtained this required certification. You will notice that the number of companies having obtained such a certification is sometimes very small. And as stated before the Chinese company has to prove that the device complies with the quality standards of the importing country. Unfortunately, the Order does not state how to prove this. At last, the exporter has to submit a signed form to the China customs stating the required information and confirming its accuracy. This form is also an attachment to the Order. Failing to comply with all these new rules means the exporter is liable under Chinese law.

The order has brought about a huge change. Most Chinese companies that exported medical devices never needed a local certificate since they only exported. This could mean that a lot of these companies are now barred from exporting these products, which might lead to a shortage of these goods.

The message from this order is clear, China wants better control of the export of these devices. So, if you want to buy these devices from China please be careful.

More information

If you need further information please do not hesitate to contact our Asia team:Joost Vrancken Peeters at +31620210657 orYe Yu at +31639267995.