On March 31, 2020, the Chinese Ministry of Commerce, General Administration of Customs and the Chinese National Medical Products Administration published a Joint Notice concerning Coronavirus reagent test kits, medical face masks, medical protective clothing, ventilators and infrared thermometers. It stipulates that that from April 1st, exporters of such products must prove that they have obtained China's registration certification for medical devices and have met the quality standards of the importing countries or regions. The Customs will release the products only after checking the certifications.

 

In an interview with CCTV and Phoenix, Meng Dongping, Vice-President of China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) outlined the position of CCCMHPIE on the new Public Notice:

 

 

Vice President Meng Dongping interviewed by CCTV

 

 

 

 

The outbreak and the world-spread of the novel coronavirus disease (COVID-19) are testing every country’s ability to fight the epidemic. After positive results were realized in preventing and controlling the epidemic in China, the focus has now switched to the increasingly serious situation in other parts of the world. So far, more than 100 countries, regions, and organizations have requested for our help as they are short of supply of medical protective equipment.

 

No country can overcome the challenges alone, and no country can hope to retreat safely behind high walls. During the past month, the Chinese government and companies have done everything in their power to help the world with medical supplies. Within its capacity, it is the Chamber’s role and commitment to assist Chinese companies so that they can help countries in need in the global battle against COVID-19.

 

The Ministry of Commerce, General Administration of Customs and the National Medical Products Administration made the announcement jointly. Starting on 1 April, exporters of coronavirus reagent test kits, medical face masks, medical protective clothings, ventilators and infrared thermometers must provide a hard copy or electronic statement when they submit their declarations to customs. This statement is to prove that the products have obtained China's registration certification for medical devices and meet the quality standards of the importing country or region. The Notice sends out a clear message that China has and will continue to place a high priority on ensuring the quality of medical supply exports.

 

 China is a major producer and exporter of medical and health products, especially in medical protective equipment. Although China's own task of fighting the epidemic remains daunting, we offer a helping hand in the global fight against the coronavirus.

 

 Access to medical supplies is a matter of life and health. Instead of pursuing export volume, we prioritize sending them to places in urgent need as quickly as possible. Aware that we all live in one single, interconnected world, for months China has done everything in its power to help the world.

 

 The Notice has drawn considerable attention at home and abroad. The Notice addresses foreign buyers’ concerns for lacking access to supplies or the risk of buying counterfeit products, and we have received positive feedback from the international community. We encourage and assist Chinese companies to register  their products with the local regulatory agencies. At the same time, we report market feedback and company requests to the public administrations in order to work out solutions together.

 

According to international trade conventions, it is the importing country which is responsible for controlling the quality of imported products. But we want to be pro-active and help the international community fight the epidemic, and the public Notice requires that exporters ensure the quality of their products and meet relevant standards and requirements. It shows both Chinese emphasis on exports quality and our willingness to strengthen international cooperation.

 

 Many companies are now applying for overseas quality certification. Some exports were impeded at customs due to the exporters’ lack of knowledge of importing country’s standards. Each country has its own regulatory system for medical products, which sets different quality standards.

 

The European Union requires that medical equipment should have CE marking before entering the European market. 

 

The reviewing and issuing of the CE certificates. This are under supervision of the EU and are carried out by the notified bodies. All the notified bodies have a unique four-digit code, the announcement number. To certify medical devices sold in EU countries, relevant EU medical device regulation 93/42 / EEC (hereinafter referred to as MDD) shall be complied with. At present, there are 56 authorized notified bodies with certification qualifications, including TUV and SGS. 

 

EU 2017/745(hereinafter referred to as MDR)  is a new EU medical device regulation. As an upgraded version of the MDD, this regulation will take effect and be fully implemented on May 26, 2020. And on March 25th, the European Commission announced a proposal to postpone the implementation of the MDR for one year and submitted it in early April in order for the European Parliament and Council to pass before the end of May. Both MDD and MDR specify the performance of products to ensure the health and safety of users.

 

Different categories have different regulatory rules, the key of which is quality control. Products manufactured in accordance with regulatory requirements can be circulated freely in the entire EU market, and each EU member state must not impose additional and different requirements on the manufacture and marketing of such products.

 

Face Mask. It is divided into medical face masks and personal protective face masks.

 

-Medical Mask. European standards for medical mask is EN14683, with three levels: TYPE Ia / TYPE II / TYPE IIR. Medical mask should affix the CE marking but the quality requirements for the use of healthcare workers (Type II and Type IIR), patients and other populations during epidemics are different.

 

Medical mask also have sterile and non-sterile types. Sterile medical masks must be CE-certified by the notified bodies, while the non-sterile ones are self-certificated and its manufacturer should submit a technical declaration through a local agent in the EU.  This type of products needs to meet certain requirements to obtain CE qualification£ºcompleted technical documents£¬qualified labels and instruction, tested products and local distributers.

 

-Personal Protective Mask. European PPE standards for masks is EN149, with three levels: FFP1/FFP2/FFP3. EU official website lists 112 notified bodies to issue CE certificate for PPEs.

 

Protective clothing. European standards for medical protective clothing is EN14126. Protective clothing can also be divided into medical protective suit and personal protective suit, whose management requirements are basically similar to those of masks.

 

Test kits. As for test kits, exporters should provide a self-declaration of compliance and submit technical documents to European authorities through local agents in order to get a tracking number. Many COVID-19 test kits producers only have a self-declared document with no tracking number, which means they are still in the process of getting CE certification. We have detected certification fraud, with some unauthorized agency having issued invalid CE certificates to some Chinese companies unfamiliar with European laws.

   

 

The United States requires that medical equipment should be in compliance with  FDA requirements to enter into the US market.

Face Masks. It is divided into medical face masks and personal protective face masks£¬ which are under separate managements. Medical masks are regulated by the US Food and Drug Administration (FDA), and personal protective masks are regulated by the National Institute of Occupational Safety and Health (NIOSH).

 

As for surgical N95 masks, it is regulated as  Class II medical device. If the product get NIOSH certification, it can be exempted from the 510K. Under the current epidemic situation, the US government has issued Emergency Use Authorization. Products without NIOSH certification can submit a EUA application to the FDA, and can lunch to the market after being approved.

 

 

Since the publication of the Notice, disinformation and rumors have spread online. One of these rumors was about alleged Chinese restrictions on export. The China Chamber of Commerce has made a timely clarification through various official channels to provide market operators with the right information. Chinese exporters do routine declarations to customs following the Notice. The Chinese government fully supports the exports of medical supplies in an orderly and market-based fashion.

 

 

The Chinese government attaches great importance to quality and regulatory compliance of exports. The so-called quality defects covered by foreign press turned out to originate from misuse or misunderstanding rather than from fake or faulty goods. After research, we discovered that the masks purchased by Dutch buyers from Chinese companies were not designed for surgical use. Relevant companies had made it fully clear in their contracts that those masks were not to be used for medical purposes or for health workers in intensive care units; yet the buyers took them for medical use and made a call-back later.

 

The supply of medical protective products is a highly regulated sector and each country has its own standards and regulatory system. Chinese standards are comparatively higher than that of many other countries. China forms its own regulatory system which is not in total harmony with foreign ones.

 

 

MASKS: It is common that foreign buyers take Chinese KN95 masks as equivalent to US surgical N95. Chinese standard KN95 can filter 95% of particles just like US N95 type does, but it is not fluid resistant. This why Chinese standard KN95 should not be used for medical purposes, especially not for contaminated area like ICU. US surgical N95 type, has a special coating to be fluid resistant. It is used in fever clinics, quarantine areas, isolation wards, and isolated ICU where aerosols might be generated during operations. The price for surgical N95 is higher and the output is relatively small. We do have surgical N95-rated masks designed for medical staff in China, called ‘medical protective face masks’, which are similar to US surgical N95. 

 

TEST KITS: Foreign end-users easily confuse two types of test kits. Take Spain for example. Nucleic acid tests and antibody tests are two different types of tests, both of which can confirm whether the patient is infected. It takes only 15 minutes for an antibody test to provide a result easily identified by the human eye. It is more adapted to large-scale testing. Nucleic acid testing takes longer time and can only be conducted in labs, taking 2 to 8 hours; but is more accurate.

 

The reason why the antibody test is less accurate is related to timing. The premise for antibody testing to work is that the patient was infected and that his or her immune system has already generated antibodies against the novel coronavirus. If the patient is infected but has not generated antibodies yet, the antibody testing will not work.

 

By contrast, the nucleic acid test traces RNA, a unique gene of the virus, which makes it golden in terms of accuracy. As long as the collected sample accumulates a certain amount of virus, the PCR method will detect it. So the nucleic acid testing does not need to wait for the patients to generate antibodies, enabling it to detect the virus at an earlier stage.

 

Therefore, we urge exporters to make clear product descriptions and to ask buyers to specify their needs and help them to fully understand products standards and applications. If there is a dispute, the two parties should resolve it according to the contract. No one should use it for scandal or political games.

 

 

For years, CCCMHPIE has been devoted to promote international exchanges and cooperation in medical and health industry. It is our job to defuse the confusions, develop trust and build a solid platform for international cooperation.