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Chinese firms cautious of shifting US medical supply standards

Global Times

By GT staff reporters Source:Global Times Published: 2020/5/8 18:08:40

Chinese mask producers recently barred by US authorities due to quality issues will spur domestic manufacturers to strengthen quality supervision to help the world fight the COVID-19 pandemic, while exporters should also be cautious to receive orders due to various standards and shifting restrictions from different markets, Chinese industry insiders said on Friday.

The comment came after the US Food and Drug Administration (FDA) said Thursday that it had cut the number of Chinese mask producers approved to make N95-style masks for use in the US to 14 from 80 because such masks fall short of N95 filtration standards, the Wall Street Journal reported.

One brand filtered out as little as one percent of particles, while others fell well below the 95 percent threshold, the report said, citing a test conducted by the National Institute for Occupational Safety and Health.

This differs from the US decision in early April that allowed imports from companies whose masks had been tested by an independent laboratory instead of being reviewed by American authorities.

Due to the surging US demand for medical masks, Chinese firms only needed to provide a test report that met local requirements in China and corporate information, and can then receive emergency use authorizations from the US and enter the market in early April, said Cao Haochun, founder of Weini Technology Development Co (Weini), based in Guangzhou, South China's Guangdong Province.

Weini is among the remaining 14 firms that obtained the approval from the FDA.

Cao's company has been producing masks and clothing for over 20 years, mostly for export markets, and obtained the CE marking from the EU years ago.

"We were authorized by the FDA in early April and have exported more than a million N95 masks to the US… Our CE qualification certification facilitated our entry into the US market in a smooth manner," Cao told the Global Times on Friday.

"Under such context of easy entry to the US last month, qualities differed from firm to firm. Some non-mask producers hoped to enter the industry, but couldn't guarantee the quality of mass-produced masks," said a Shanghai-based expert surnamed Xu in export qualification certification.

"Those firms failed to reach the US' selective examination, resulting in being excluded from the market," Xu told the Global Times on Friday.

But due to various standards of medical equipment qualifications, though some products meet Chinese standards, the US may also restrict such products due to its own requirements, Xu said, noting the changing US requirements are also an alert to domestic medical suppliers.

An industry insider surnamed Wen, who's been working as an agent for Chinese firms to export masks, told the Global Times on Friday that Chinese firms have taken a cautious attitude when receiving orders from the US.

They are always "unfriendly to products from China," Wen said, adding that it's normal to see that after receiving masks from Chinese firms, they would sue them over so-called quality issues or something else.

"Who would want to risk provoking a lawsuit at this time? Not me for sure," Wen said.

Wen said US standards for masks are also stricter compared to other countries, so it's also possible that the masks passed through Chinese customs while failing in the US. "It's risky and I always advise every Chinese factory to avoid exporting to the US."

California will be refunded $247 million it paid to Chinese company BYD under a major deal for protective masks after the company failed to meet a deadline for federal certification of the masks, media reports said.

After some foreign complaints arose over the quality of China-made medical supplies, Chinese authorities have strengthened crackdowns and regulations on exports of medical supplies. As of Wednesday, a total of 3,773 companies had received China's medical equipment registration certificates, a new document required from April 1 to ensure product quality, China's Ministry of Commerce said.

On April 25, Chinese authorities issued another statement to tighten the regulation of non-medical use face masks, requiring them to meet domestic or foreign standards.