Overview of Exportation of China’s Medical Products against Covid-19

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What is the overview of China’s mask exports?

As COVID-19 spreads and proliferates across the world, an increasing number of countries are asking China for help. So far, we have exported anti-epidemic supplies to 191 countries and regions through commercial procurement. According to Customs statistics, from March 1 to April 25, China inspected and released related exports worth RMB 55 billion, including 21.1 billion masks. Currently, the daily mask exports are close to 1.4 billion, way higher than the 224 million before the introduction of Notice No.5 and are still growing.   

Many countries have expresses their appreciation for China in various ways, recognizing the enormous efforts of the Chinese society from the government to the business in support of the fight against the virus all over the world, not least the key role of China-made masks in the global response despite domestic needs in prevention and control.

Regarding product quality requirements and compliance, are there quality issues (what is the main cause of disputes)?

The Chinese government takes very seriously the quality and compliance of export products. Upon requests for help from across the world after the outbreak, large quantities of anti-epidemic supplies were exported worldwide. In concert with several departments, MOFCOM successively issued Notice No.5 and No.12, laying down express export quality requirements for medical supplies such as face masks, gowns and testing kits and non-medical face masks, among other key products. In particular, improving on and optimizing No.5, No.12 allows export in multiple trade modes.

Both notices have made clear the attitude and stand of the China government that we will secure export quality and hold trade conduct to strict regulation to ensure the safety and efficacy of anti-epidemic exports. China is a major producer and exporter of medical and health products, especially anti-epidemic supplies. Our economy was hit hard by the epidemic. Nonetheless, at this special time of epidemic combat, rather than going after export quantities and numbers, we are emphasizing time and again export quality safety and compliance. While organizing for orderly exports, we are stressing respect for local laws and regulations, the market law and trade competition rules.   

According to common practices in international trade, the importing country is wholly responsible for regulating the quality of imported products. However, the two Notices still clearly require that the exported medical and epidemic prevention supplies should comply with the quality standards and requirements of the importing country and region. The aim is to deliver epidemic prevention materials that meet the quality standards of the countries to the places where they are most needed as soon as possible and to help countries around the world in their fight against the epidemic. It shows that an objective, pragmatic and responsible attitude by the government of China and its respect and commitment for life and health.

The quality of Chinese products under foreign media hype

We have noticed that, from time to time, there is some foreign media coverage stating the quality problem with Chinese epidemic prevention supplies and we attach great importance to such issues. Not long ago, during my interview on Notice No. 5, I have mentioned that we tracked several cases being reported with the so-called quality problems. After investigations, we found that in most of such cases, it was because that during import, distribution and usage, the sellers and buyers or people involved do not fully understand the specifications, standards and requirements of relevant products, or fail to strictly follow the instructions of the contract, causing unnecessary consequences and impacts. As a matter of fact, these are not real quality issues.

About standards

1. Are Chinese KN95 masks equivalent to US Surgical N95?

The KN95 masks under the Chinese standard can filter 95% of particles just like US Surgical N95 masks, but it is usually for the general public. It is not fluid resistant. It is usually used for general protection against dust and small particles under a relatively low price. It cannot be used for medical personnel in medical institutions, especially in heavily polluted areas such as ICU, what we call hospital red zones.

US Surgical N95 masks , use a special coating technology to keep them fluid resistant and block droplets. It is relatively expensive. In principle, it is used in the fever clinic, quarantine observation ward, quarantine ward and quarantine ICU of the hospital, as well as during the operations that may generate aerosol. It is relatively small in quantity.

In fact, the Chinese masks equivalent to US N95 medical masks are Chinese medical protective masks, instead of KN95 masks. KN95 is for daily use, while medical protective masks is for medical purposes. Therefore, we would like to remind importers that they should use the masks properly in strict accordance with the requirements set out in contracts.

2.What are the differences between Chinese KN95 masks and European FFP2 masks? What occasions are KN95 masks suitable for?

Chinese KN95 masks are tested for protection against saline particles, not against oily particles, and only KP95 masks are tested for protection against oily particles. Therefore, it is likely that the masks that have passed KN95 tests may fail to pass the FFP2 test for protection against paraffin oil aerosol. Here, N stands for "Non-oil" (non-resistant to oily particulates), and P for "Oil protective" (resistant to oily particulates).

KN95 masks are suitable for protection against solid and non-oily particulates, liquid and microorganisms such as coal dust, cement dust, acid fog, paint fog, etc. However, they provide limited protection against oil smoke, oil mist, asphalt smoke, coke oven smoke, particulates in diesel exhaust, etc.

3.What are the differences between Chinese mask standards and European and US mask standards?

According to regulations, exported non-medical masks must conform to Chinese product standards such as GB2626-2006 and GB/T32610-2016, or meet the quality standard requirements of the importing country or region, such as the EU Regulation 2016/425, which is known as the Personal Protective Equipment Regulation (PPE Regulation). 

The product classification and corresponding indicator requirements in China and foreign countries cannot be equated to one another. For example, different non-medical masks have different breathing resistance. GB2626 classifies products into three levels according to the leakage rate and filtering efficiency of the mask, and products at each level are classified as saline particulate-resistant and oily particulate-resistant; GB32610 classifies products into four levels (A, B, C, D); and EN149 only classifies products into three levels of FFP1, FFP2 and FFP3. Therefore, the standards do not correspond to one another. 

For the standards of masks for daily use, China has GB 2626-2006 "Respiratory Protective Equipment—Non-Powered Air-Purifying Particulate Respirator" and GB/T 32610-2016 "Technical Specifications of Daily Protective Masks". They are both for masks for daily use, vastly different from GB 19083-2003 "Technical Requirements for Medical Protective Face Masks". The European Union's testing standard for masks for daily use is EN149-2001+A1-2009 "Respiratory Protective Devices - Filtering Half Masks to Protect against Particles - Requirements, Testing, Marking", and its standard for medical face masks is EN 14683. The US applies relavant NIOSH standards. Therefore, there are lots of differences in different countries’ testing standards in terms of the classification of product levels and specific testing indicators. We cannot simply equate one testing standard with another.

The supply of medical protective products is a highly regulated sector and each country has its own standards and inspection requirements. Chinese standards for medical protective products are relatively higher than many other countries. China forms its own regulatory system covering the approval, standard management, inspection and certification of products, which is not completely the same with foreign ones. 

4.How effective are the test kits exported from China? How do you explain the relatively low accuracy of these test kits used by European countries?

Huge quantities of test kits are being exported from China to Europe, Asia and Latin America and have been well-received by relevant countries and regions. Nevertheless, we have noted some negative coverage of the effect of the Chinese test kits. There are strict requirements for the storage, transportation and usage of the novel coronovirus antibody test kits. Antibody testing must be carried out by professional staff in accordance with product instructions, otherwise low accruacy or errors might occur.
Besides, both nucleic acid tests and antibody tests are qualitative testing. Foreign end-users could eaily confuse these two different types of testing, as exemplified by the dispute over test kits in Spain. An antibody test could return results in as soon as 15 minutes and could be easily identified by the human eye. It is more adapted to mass testing. The nucleic acid testing is more suitable for individual cases. A nucleic acid test normally takes 2 to 8 hours and must be conducted in labs.

The antibody testing is less accurate partly due to the inapproriate timing for testing. Such tests could only work on the premise that the patient was infected and has developed antibodies against the virus. If the patient is infected but has not generated antibodies yet, the antibody testing would not work. By contrast, as the “gold standard” for confirming SARS-CoV-2 infection, the nucleic acid testing can directly trace the viral genetic material. The PCR method would detect the virus as long as a certain amount of virus is accumulated in the sample collected (detection sensitivity varies among products produced by different companies). Compared with the antibody testing, the nucleic acid testing could detect the virus at an earlier stage without waiting for the patient to develop antibodies. The second reason for the accuracy issue is related to improper sampling. Nucleic acid tests may also give false negative results if the virus collected in the sample is only present in very small amounts and not able to send a strong enough signal to turn the test positive. This is largely due to incorrect sampling or the fact that the point where doctors collect the sample is not deep enough in the patient’s body.

To avoid similar problems, Notice No.12 requires a joint declaration to be signed by the exporter and importer to confirm that relevant product quality standards are accepted by both sides, and the importer commits that the non-medical face masks purchased would not be used for medical purposes. We caution buyers to carry out testing and inspection on the imported products and use these products in strict accordance with the operational instructions, requirements and scope of application specified in the contracts. In case of any problems, we suggest the two sides resolve the disputes through communication and consultation.




2020-05-01 11:10