We’ve long shared with partners that many of the COVID-19 rapid test kits being exported from China don’t meet medical standards, including in China itself. Many such kits have been developed and sold by startups or otherwise young companies with no medical expertise or background in medical testing.
We’ve also warned that supplies for legitimate makers have been running short in the face of a run on untested, unreliable, and wholly cheap kits.
Today the government of China has taken action to prevent the export of poor quality tests. The same action also helps ensure that the supplies and components needed made to manufacture legitimate and clinically trialled tests remains available.
In a note which the Aeotec Health team shared with partners on 31 March, we wrote;
Please note that start 00:01 Beijing time, the Ministry of Commerce of the People’s Republic of China has implemented new laws and requirements which impact the production and export of COVID-19 medical tests and protective / preventative equipment.
In short, announcement #5 of 31 March 2020 by the PRC places restrictions on the manufacture and export of all related tests and equipment that have not been manufactured with the correct combination of licenses and certifications. All goods related to announcement #5 will be inspected by Chinese customs. Those without the correct combination of licenses and certifications in place will be impounded and confiscated
Announcement #5 applies to all coronavirus tests, rapid or otherwise, medical masks, medical protective clothing, ventilators, and thermometers.
Aeotec Health’s sourcing team has worked today to secure a complete understanding of the new and necessary licenses and certifications. We have a number of suppliers in place accordingly and, given that the number of qualified suppliers is extremely low, have begun negotiating exclusivity agreements with them already. Others have done the same and we see the time window as shorter than 24 hours for purchase orders to be placed.
We expect this to affect global supply and demand immediately. For our European partners, regulated and certified PRC made tests and Bosch’s 3-hour invasive test will become the only 2 available options for the time being. We have encountered some PRC made kits being imported into Europe and rebranded as ‘made in Europe’ once within Europe’s borders. We expect the Chinese sources for this illegal activity to dry up within the first few weeks of April.