People wearing masks stroll on Chuhehan Street, a shopping center in downtown Wuhan, Central China's Hubei Province on Monday after 67 days of lockdown in the city due to the COVID-19 outbreak. The banner behind them proclaims "We are back." (See story on Page 4) Photo: Cui Meng/GT
By GT staff reporters
However, by interviewing over a dozen companies and industry insiders and analyzing recent media reports and a series of Chinese official documents, the Global Times discovered that while risks of quality issues do exist due to a combination of factors from illegal production activities to improper procurement channels, shortages in crucial foreign materials and loopholes in foreign regulations that require attention from all governments, a vast majority of Chinese-made medical equipment is not only up to standard but has helped many countries around the world to stem the ongoing coronavirus pandemic.
Hyping up and politicizing quality issues based on several individual cases is not only counterproductive in the global fight against the pandemic but could also be dangerous going forward, as many countries are running out of the life-saving equipment, Chinese officials, businesses and analysts warned.
Chinese Ministry of Foreign Affairs also warned against politicizing the issue in a Monday routine briefing.
Issues with masks
Questions over the quality of Chinese-made masks have gained much attention after Dutch authorities ordered a recall of 600,000 face masks from China citing a variety of issues including masks not fitting health workers’ mouths properly and not having sufficient filters. Dutch officials said that the KN95 masks should filter out at least 95 percent of airborne particles, but the masks couldn’t filter them out.
While the Netherlands did not provide further details, the issues might have much to do with the fabric used in the masks to filter out airborne particles – a material that China relies on importing from Switzerland and Turkey, according to Chen Lianjie, an executive at Zhejiang Kanglidi Medical Articles Co.
“There is a shortage of meltblown nonwoven fabric,” Chen on Monday told the Global Times, noting that many fabrics in the market are labeled as capable of filtering out between 95 percent and 99 percent of particles, but tests show that this is only around 70 percent. To make high-quality fabric would also require equipment from Germany, which is dealing with its own shortages at home.
“This is the source of the problems faced by China’s medical-grade mask production,” Chen said.
There are two different types of masks – one that is only good for filtering out particles and the other is classed as medical-grade that can filter out the virus. But due to surging demand, there has been a “mix of good and bad” in the market, Chen said.
Some Chinese companies have been engaged in illegal production and selling of masks and other medical products, and China has responded by stepping up crackdowns on these companies, according to Chinese officials.
The State Administration for Market Regulation (SAMR) on Monday released its 10th round of examples of five companies and individuals that have been engaged in illegal production and sales. Officials confiscated the products and issued fines up to 1.18 million yuan ($166,130).
However, issues regarding quality of masks does not stop here. There are also a slew of problems in regards to the process of obtaining export certificates and foreign procurement channels, according to companies and industry analysts.
A majority of certifications are granted by intermediary agents in China hired by foreign governments. For instance, 90 percent of these so-called “US Food and Drug Administration” certifications are granted by these agents which are not approved by US authorities, which raised problems for trading process, according to a Shandong-based trader.
“If they don’t purchase through officially recommended channels, foreign buyers may face products with differing quality standards, especially in regards those newly established producers which might not have obtained comprehensive certification before exporting products overseas,” the trader, who spoke on the condition of anonymity, told the Global Times on Monday, adding that certain foreign purchasing agents haven’t followed a list of suppliers provided by Chinese officials because they are in a rush.
What made such irregularities possible are changing standards from foreign governments. Both the EU and the US have lowered market restrictions for the import of masks and other medical supplies due to shortages at home, including lowered tariffs and fast-tracked procedures, according to the China International Chamber of Commerce (CICC) on Monday.
For example, the EU has allowed Chinese medical products to be exported even before they gained regulatory approval or without the “Chinese export” label, the CICC said.
Regarding the masks the Dutch officials have asked recall, it was unclear whether they had gained proper
certification and were purchased through proper channels as the officials did not disclose the source of the masks.
Test kit accuracy
Many issues experienced recently in mask exports, including purchases made through channels unverified by Chinese authorities, are also faced by other medical supplies, such as crucial testing kits, which have faced inaccuracy claims.
The Spanish government last week withdrew 8,000 orders of rapid testing kits from China because of inaccurate results, according to media reports. Some other countries, including the Philippines and the Czech Republic, have also reportedly claimed that some Chinese-made testing kits are inaccurate.
However, probing into these incidents also revealed that foreign procurement agents and officials failed to follow specific instructions released by Chinese authorities. In the case of the Czech Republic, local health officials did not follow instructions on how to use the testing kits.
The Spanish government purchased the testing kits in question from a company called Shenzhen Bioeasy Biotechnology. But the Chinese Embassy in Spain said that the company was not approved by Chinese authorities and was not included on a list of 12 suppliers the Chinese Ministry of Commerce (MOFCOM) provided to Spanish officials. Bioeasy also said in a statement on Friday that Spanish health workers probably have not followed instructions provided by the company in collecting testing samples.
An insider close to the matter told the Global Times on Monday that the intermediary for the purchase had contacted several manufacturers in China but decided to buy from the Shenzhen-based firm because it was the first to respond.
“Such incidents reflect an eagerness of foreign companies and governments to seek medical supplies in order to meet growing domestic demand, however, some have been so anxious in inking orders that they sometimes ignore strict quality control procedures,” said the insider, who spoke on the condition of anonymity.
That was also the case with the incident in the Philippines, where officials claimed that some Chinese-made testing kits produced inaccurate results.
The Chinese Embassy in the Philippines said on Sunday that those testing kits were not donations from the Chinese government and did not receive any kit samples for lab validation. The Philippines’ health department also apologized for the comments and said that all testing kits donated by China are up to standards.
In the case of the Czech Republic, where some media reports claimed that inaccuracy rates of rapid testing kits from China were 80 percent, the problem may have been “improper use” by some Czech officials, the Chinese Embassy in the Czech Republic said on Friday, adding that the claim was false.
Test results could also vary given the different types of methods and different performances conducted by officials, according to analysts.
Currently, there are two types of testing methods for COVID-19 that have been approved by China’s National Medical Products Administration: nucleic acid and antibody testing methods. While antibody testing methods produce results in 15 minutes, the nucleic acid testing has “strong specificity and relatively high sensitivity,” according to a statement from the Chinese Embassy in the Philippines.
Unlike masks and other products, production of such test kits does not rely on foreign imports of materials and technologies, according to an executive from BGI, noting that the company developed its own test kits, and all production materials are made domestically.
Therefore, the primary problem behind concerns regarding testing kits may have more to do with the source of such kits and the ability of foreign health workers to use them properly, according to industry insiders.
“For some complicated products, we cannot say that all importers know how to use them. Some importers probably did not use them as instructed,” Li Yong, deputy chairman of the Expert Committee of the China Association of International Trade, told the Global Times on Monday.
As of March 23, China has approved 20 types of nucleic acid and antibody testing kits made by Chinese companies, according to a list posted by the Chinese Embassy in the Philippines on March 24.
Ventilators
While so far quality concerns have been focused on products such as masks and testing kits, there could also be risks of quality and price irregularities for other devices from China such as ventilators and infrared thermometers, which have become a hot commodity as the number of COVID-19 cases surge overseas, industry insiders and analysts warned.
China has received 20,000 orders for ventilators from overseas customers and more orders are under discussion, Xu Kemin, an official with the Chinese Ministry of Information and Technology (MIIT), told a press briefing on Monday, adding that China has already exported 1,700 ventilators, half of the country’s output this year.
However, like masks and some other products, the production of ventilators also relies on supplies of key materials from overseas, including from Europe.
“Expanding production scale is not an easy thing given the impact of the pandemic, and meeting all demands is unrealistic,” Xu said.
That could lead to pricing speculation and even have impacts on the quality, as there have already been irregular sales activities.
Beijing Aeonmed Co, which exports ventilators, said that there have been reports of resales of its products for higher prices and the company has nothing to do with them. Li Kai, an executive of the company, told the Global Times that the company has not raised the price of its ventilators and all its products go through inspections before being exported overseas.
Cui Gang, clinical director of Beijing Siriusmed Medical Devices, another ventilator producer, also said that the company has been focused on quality of its products and, despite rising costs, have not raised prices. Cui said that the company’s ventilators are priced between 100,000 yuan and 200,000 yuan one unit.
“Currently, we mainly get orders via existing foreign dealers and governments and the manufacturing is in strict line with the time the orders are received,” Cui said.
Though ventilators are hard to produce, there could also be some sub-standard ones emerging given market demand, and foreign purchases should be made through proper channels, insiders warned.
Xu with the MIIT said on Monday that there are 21 Chinese companies that can produce ventilators, but only eight have received certification from the EU.
The same risks also exist for Chinese-made infrared thermometers, which are used to check body temperatures in potentially tracking down COVID-19 cases, as foreign demand is skyrocketing and domestic production is strained by shortages of foreign components, insiders said.
Du Han, CEO of Beijing-based Comper Healthcare, which produces 10 percent of China’s total infrared thermometers, said that domestic production relies on imports of sensors and chips from Japan and other countries, which are also facing their own shortages.
Similar to masks, the market for infrared thermometers is in chaos, as substandard products are being sold in the market, Du said.
“Some companies do not have the certification to produce infrared thermometers. So they are illegal producers,” she said.
In a statement on Monday, MOFCOM said that along with other agencies, it would intensify efforts to ensure export orders of medical products and crack down on counterfeit products. The ministry also said that it would release a list of requirements for export of medical products and urged foreign procurement agents to purchase products that are on par with these requirements.
Politicizing – the biggest issue
While issues exist regarding the quality of certain products, the biggest problem Chinese products face is ideologically driven bias toward everything associated with China, Chinese businesses and analysts said.
“There have been some biased tendencies among some people, including politicians, to smear China’s medical supply production. Such noise is counterproductive in the fight against the pandemic.
Such political motivations are evil,” said Li, the trade expert, adding that specific issues should be addressed through collaboration.
Hua Chunying, spokesperson for the Chinese Foreign Ministry, on Monday also warned against politicizing quality issues, which should be addressed based on facts, and she said that China’s help is sincere. Hua also noted that China has also received substandard medical supplies from other countries, but “we chose to have faith in and respect other countries’ goodwill.”
Responding to some foreign officials’ comments over China using the medical supplies as “propaganda,” Hua asked rhetorically: “Do they wish for China to sit idly by and be indifferent, while watching people in many countries suffering in pain due to the pandemic and more people lose their lives?”
