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Official guidance for importing Chinese PPE and medical devices

Procuring PPE has emerged as one of the main challenges facing the NHS, as it seeks to treat patients with coronavirus and contain its spread. Official guidelines have been published for British businesses seeking to procure and import PPE and medical devices from China.

There is significant and increasing demand for Chinese manufactured medical equipment, but procuring medical supplies from China is becoming ever more complex and should be approached with caution.

The British Embassy in Beijing advises businesses seeking to procure medical supplies from China to focus on procuring pre-existing stock from manufacturers and large Chinese healthcare distributors only.

While there are a number of intermediaries on the market, the Embassy is hearing reports that these intermediaries are committing pre-existing stock to British businesses without receiving a pre-existing stock allocation from the suppliers.

In addition, China’s customs requirements for PPE exports are becoming more complex.

Following the announcement of ‘GACC No. 23’ by China’s Customs Agency, 11 categories of medical devices (masks, disinfectant, gowns, gloves, goggles, ventilators, COVID-19 testing kits, syringe pumps and infusion pumps, and ventilator consumables [breathing filters, circuits, masks, humidifiers etc.]), are now subject to intensified commodity inspection, which inevitably will slow down customs procedures.

See also our new post “China tighten PPE export controls even further”

It is essential for buyers to know if a product is a medical device or not, which depends on the standards to which the product adheres to.

For example, if a mask is compliant with EU medical mask standard EN14683 then it is a medical device. However, if a mask is compliant with EU PPE standard EN149 then it is not classified a medical device.

Chinese customs officials usually inspect to see if:
Products match with medical device registration certificate
Products’ packaging, label, name and quantity match with customs declaration
Product safety and quality statement and testing reports submitted by the company
The quality of the product and sample for laboratory testing if necessary
 
Non-medical products are NOT subject to inspection, oly masks, disinfectant, gowns, gloves, goggles, ventilators, COVID-19 testing kits, syringe pumps and infusion pumps, and ventilator consumables (breathing filters, circuits, masks, humidifiers etc.) will be subject to a commodity inspection.