Chinese mask makers are taking advantage of loopholes in EU and US regulatory procedures to speed up device manufacturing and sales as they race to meet the explosive growth of overseas demand in response to the global spread of coronavirus.
In Spain, the Netherlands and Turkey, the relevant authorities have announced the quality inspection of Chinese-made equipment, these news will further cause people's attention. Reject mask and test Not qualified in recent days.
Chinese manufacturers use strategies that account for half of the global production of surgical masks, including adjusting product descriptions and expediting testing procedures.
The industry has grown rapidly since the factory increased its ability to provide medical services to Chinese medical professionals and citizens in January. According to official data, by the end of February, China was producing 116 million masks per day, about 12 times the beginning of the month.
Beijing eased export restrictions on medical equipment in March after officials asserted that the domestic epidemic is slowing. This has prompted factories to look overseas because of the spread of coronaviruses in Europe and the United States and severe shortages of medical equipment.
In the UK, health care workers have Complain of lack of protective equipment. U.S. Secretary of Health and Human Services Alex Azar said on March 4 that the country accounted for only 1% of the 3.5 billion masks needed.
A director of Guangzhou-based Osmunda Medical Device Services Group helped local mask factories achieve EU and US certification. He said that because "everyone wants to profit from the global shortage," the business has more than tripled compared to the beginning of the year.
However, Jian Runfu, head of the Guangdong Medical Device Management Industry Association, said that since the beginning of 2020, the defect rate on masks has doubled.
Mr. Jian said, "Some Chinese factories are so keen to use this virus to get rich and to do their best."
This includes many companies without relevant industry experience. According to official data, from clothing factories to electronics manufacturers, nearly one-fifth of China's mask factories will only start operating after January.
An official at Zhejiang-based auto parts maker Joyson Electronics started producing masks in February. "When the disease disappears abroad, the window of opportunity disappears," he said.
From product testing to technical documentation review, Chinese factories often have to pass strict regulatory procedures to win EU or US approval.
An official at TÜVSÜD, a Guangzhou-based certification body, said it takes at least 60 days to obtain certification for masks in Europe and 6 months in the United States.
However, many Chinese factories are trying to find ways to speed up this process.
An official at Shenzhen Tianhai Testing Technology Co., Ltd. said that the company can complete a surgical mask test in 10 days. To this end, for example, it advises customers to avoid using "medical", "surgical" or "surgical" in their certification applications, as the FDA imposes stricter measures on medical masks than personal masks.
"We need to exploit the loophole left by the FDA," an official at Tianhai said.
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Tianhai's Liaoning customer Shengjingtang Biotechnology Co., Ltd. started producing masks in February. The company said it has sold 20 million medical masks to the United States and 23 million to Europe.
An official at Shengjingtang Biotechnology Co., Ltd. said: "We are ready to serve foreign markets because we have quickly obtained the relevant certification."
The FDA did not respond to a request for comment.
The European Commission said it did not see any examples of Chinese manufacturers using regulatory loopholes.
EU regulations allow medical devices to fall into one of two legal frameworks. Personal protective equipment, including disposable and reusable masks, ensures protection from particulate hazards and requires third-party certification. However, certain products (such as masks) may be subject to the Medical Device Directive, which allows for self-certification.
Bird & Bird's Hong Kong-based lawyer specializing in medical equipment, Anthony Wilkinson, said the EU and the United States have relaxed regulations on medical equipment imports because "our situation is very different from normal procedures. .
He added that FDA rules created a loophole that exempted certain medical devices from rigorous inspections. But "someone in China says that they can do certification does not necessarily mean it will be accepted at the other end."
Mr. Jian of GMDMA said this could have a negative impact on the industry and customers. "Although the barriers to producing masks are small, there are barriers to maintaining quality control," he said. "Inexperienced factories may end up hurting their overseas customers and themselves."
Other reports by Michael Peel in Brussels and Kiran Stacey in Washington