Chinese makers of face masks are taking advantage of loopholes in EU and US regulatory processes to speed up the manufacture and sale of the equipment, as they race to meet an explosion in overseas demand to combat the global spread of coronavirus.
The revelations will add to concerns about the quality of Chinese-made equipment after authorities in Spain, the Netherlands and Turkey all rejected masks and tests as substandard in recent days.
The tactics used by Chinese manufacturers, which account for half of global output of surgical masks, have included tweaking product descriptions and speeding up testing procedures.
The industry has expanded rapidly since January when factories increased capacity to supply Chinese medical professionals and citizens. By the end of February, China was making 116m masks a day, about 12 times more than at the beginning of that month, according to official data.
Beijing eased export curbs on medical equipment in March after officials asserted the pandemic was slowing at home. That prompted factories to look overseas, where there has been an acute shortage of medical equipment as coronavirus spread across Europe and the US.
In the UK, healthcare workers have complained about a lack of protective equipment. Alex Azar, the US health and human services secretary, said on March 4 the country had only 1 per cent of the 3.5bn masks it needed.
A director at Guangzhou-based Osmunda Medical Device Service Group, which helps local mask factories obtain EU and US certifications, said business had more than tripled from the beginning of the year as “everyone wants to profit from the global shortage”.
But Jian Runfu, an official at Guangdong Medical Devices Management Academy, a trade association, said the rate of defective masks had more than doubled since the start of 2020.
“Some Chinese factories are so keen to make a fortune from the virus that they are cutting corners where they can,” said Mr Jian.
This has included many companies with no relevant experience entering the industry. Almost a fifth of China’s mask factories only began operating after January, according to official data, ranging from apparel factories to electronics makers.
An official at Joyson Electronics, a Zhejiang-based auto parts maker that began producing masks in February, said: “The window of opportunity could go away when the disease fades abroad.”
Chinese factories typically go through a rigorous regulatory procedure to win EU or US approval, ranging from product testing to technology document review.
An official at TÜV SÜD, a certification agency based in Guangzhou, said it took at least 60 days to acquire surgical mask certification in Europe and six months in the US.
But a number of Chinese factories have tried to find ways of expediting the process.
An official at Shenzhen Tian Hai Test Technology Co said the company could complete surgical mask testing within 10 days. To achieve this, it has, for example, suggested clients refrain from using “medical”, “surgical” or “surgery” in their certification applications, as the US Food and Drug Administration enforces stricter measures for medical masks than personal ones.
“We need to take advantage of the loopholes left by the FDA,” said an official at Tian Hai.
Shengjingtang Biotechnology, a Liaoning-based client of Tian Hai, started making masks in February. The company said it had already sold 20m medical masks to the US and 23m to Europe.
“We are well placed to serve foreign markets as we have been quick in obtaining relevant certifications,” said an official at Shengjingtang Biotechnology.
The FDA did not respond to a request for comment.
The European Commission said it had not seen any instances of Chinese manufacturers taking advantage of regulatory loopholes.
EU rules allow for medical equipment to fall under the scope of one of two legal frameworks. Personal Protective Equipment, including disposable and reusable face masks ensuring protection against particulate hazards, require third party certification. However, some products such as surgical masks can fall under a medical devices directive, which allows for self-certification.
Anthony Wilkinson, a Hong Kong-based lawyer at Bird & Bird who specialises in medical equipment, said both the EU and the US have relaxed regulations on medical equipment imports as “we are in a very different situation to what the normal process would be”.
FDA rules, he added, created a loophole that exempt certain medical devices from close inspection. But “having someone in China say they could do the certification doesn’t necessarily mean it will be accepted on the other end”.
Mr Jian of GMDMA said this could have a negative effect on the industry and clients. “While there is little barrier in producing masks, there is one in maintaining quality control,” he said. “Inexperienced factories may end up hurting both their overseas clients and themselves.”
Additional reporting by Michael Peel in Brussels and Kiran Stacey in Washington
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