Necessary measure
Experts and industry veterans said the new regulation is a necessary measure to ensure the quality of exported Chinese test kits, face masks and other medical supplies, as market demand has soared since the outbreak began.
Trankmann, from the UNDP, said it is important to have a dedicated team of medical experts to source quality goods. It is also vital to have a list of certified companies that allow buyers to confirm and compare their products, she added.
On April 5, Zhang Qi, deputy director of the Department of Medical Device Regulation at the NMPA, said at a news briefing that by the end of last month, China had approved 25 diagnostic test kits. They comprised 17 nucleic acid and eight antibody kits.
Zhang Qi urged overseas buyers to obtain test kits from the list of companies provided by the Foreign Ministry. "Foreign buyers have not reported any quality issues in test kits procured through this channel," she added.
Equal Ocean, a technology investment research company based in Beijing, said in an industry report that since last month, more than 80 Chinese nucleic acid test kit manufacturers had claimed to have acquired the CE marking.
However, the report estimated the average accuracy rate of these test kits to be about 70 to 90 percent, adding that the proportion could drop significantly if the product was hastily made or mishandled during use or transportation.
Yin Ye, CEO of genome research organization the BGI Group, said that due to massive global demand there has been a significant rise in the number of companies claiming to produce and export diagnostic kits.
"Quality should be the irrefutable red line for any test kits, and false results are more damaging than no results," he said. "Test kits that are poorly made not only ruin a company's public trust, but also tarnish the national image."
