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. The CBI Beijing office would like to share guidelines drafted by the British Embassy in Beijing, to bring clarity to British businesses seeking to aid efforts to procure PPE and medical devices from China.
Given that China has emerged as one of the first countries able to bring its people out of lockdown, now that the worst of the virus has passed, there is significant demand for Chinese manufactured medical equipment outside of China. However, 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, the Embassy wishes to make businesses aware that 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.
What is it essential for business to know?
How do I know if a product is a medical device or not?
This depends on whether the standards to which the product adheres to is a medical device standard.
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.
It does not matter whether it will be used by medical professionals in the UK.
What do Chinese customs officials do during a commodity inspection?
A commodity inspection usually includes, but is not limited to, the following types of inspections:
- Inspect to see if the products match with medical device registration certificate;
- Inspect to see if the products’ packaging, label, name and quantity match with customs declaration;
- Inspect product safety and quality statement and testing reports submitted by the company
- Inspect the quality of the product and sample for laboratory testing if necessary
If my product is not a medical device, will it still be subjected to a commodity inspection?
No. Only 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.