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The Business Behind The Masks Qualification: The EU CE Certification Fee Rose To 30 Thousand.

2020/3/25 13:12:00 0

MaskQualificationBusiness BehindEU CE Certification

"Want to sell the medical devices such as masks, forehead guns, etc.? First, register a company; second, run two categories of medical devices for the record; third, handle the right to import and export, find me, step by step." This is a dynamic trend of Yang Fa in her WeChat friends circle in March 13th. Her latest friend circle for more than a month is all about masks qualification.

Xiao Yang is a consultant of a commercial service company in Shenzhen, which provides registration / alteration services for small and medium-sized enterprises. Since the beginning of February, because of the increasing number of clients who have consulted on the issue of authorized masks, their companies have begun to act as the agent of the masks qualification, providing a one-stop service from production, sales to export. Under the epidemic situation, masks are in need of blowout. Many production masks have poured in, and the application of qualification is a threshold. Production and sale of respirators, medical device business (production) permit + product registration, two kinds of medical device record voucher is the necessary qualification; export masks, import and export operation rights record and institutional certification, one back, some people smell business opportunities, so as to start acting business.

"No qualification will be caught".

"Have you noticed that there have been a lot of news about masks since February, and a lot of them have been arrested. Why have they been arrested? Or they have not been delivered, they have not paid for the goods, they are fraudulent, or they do not have the qualifications. The respirators belong to two kinds of medical devices qualification, and medical masks are required for two types of medical devices." Talking about the importance of the relevant qualification of masks, Xiao Yang told reporters that many people were arrested because they did not have this qualification, usually in the case of illegal business.

According to the relevant regulations, the management of medical device operation permits can be divided into three categories: operating a class of medical devices without permission and filing; operating two types of medical devices need to be dealt with for archival purposes; and three types of medical device licenses need relevant departments to examine and approve before they can be processed.

The medical masks belong to the two class of medical devices in the epidemic. They contain various components including sterilization, bacteriostatic and antiviral. The medical masks are expected to be used in third categories of medical devices. "Last month, the consultation office had more production licenses and more business records. In the two days, hundreds of people joined me in WeChat, and consulted me. Later, because the government tightened up the emergency record, it is now slowly decreasing. It is not impossible to do, but the cycle is lengthening. This month is the consultation mask export related qualification." In March 16th, Yang Xiang, a reporter for the daily economic news, said.

Like Xiao Yang, Liao Ling is also a qualified agent. She said that during the epidemic period, the qualification of medical devices was relaxed in many places, and other products such as selling masks or selling second class medical devices could be handled quickly. The previous two categories of medical device licensing are administrative examination and approval matters. There are many requirements such as venues and personnel at ordinary times. However, such approval has been relaxed under the epidemic situation.

The daily economic news reporter noted that as early as January 24th, the Guangdong Provincial Drug Administration issued a notice on the implementation of special management of medical masks and other preventive measures against major medical emergencies during the first stage of response to public health emergencies, and encouraged local market supervision departments to assist enterprises in preparing application materials, opening up green channels, and helping enterprises in conformity with quality standards. Achieve production transformation and expand production capacity.

A week later, the Guangdong provincial drug administration once again issued the notice on the "emergency examination and approval procedures for the administrative licensing of drugs and medical devices for the prevention and control of new coronavirus infection in Guangdong province". The supply of materials such as masks, protective clothing and other materials that are in short supply should be included in the emergency examination and approval. Obstacles need emergency response.

"When the epidemic was relatively tight, the government opened a green channel and set up a filing system. The leaders of Shenzhen went to the enterprise to investigate, and sent experts, directors and heads to the factory to guide the construction of our mask line, including environment, product quality management and so on. Zhao Jianping, general manager of BYD quality department, told reporters that after the first batch of samples passed the test successfully, BYD obtained the qualification for emergency record of Shenzhen two class medical devices.

Angel, the person in charge, told reporters that the company decided to produce masks in February 12th, consulted many production masks, and communicated with the relevant health departments and market supervision departments in Shenzhen. Now the production of KN95 masks has passed the latest indicators of the national GB2626-2019 standard, and has been certified by the market supervision Department of Shenzhen. The qualification and ability of production and operation.

Tightened approval for mask production license

According to the press survey, the two types of production license + product registration certificate (production) quoted price is 150 thousand ~20 yuan, and the two kind of medical device record is sold at 150 thousand yuan, and the import and export operation rights record (export) is quoted at 2000~3000 yuan. The increase in the demand for masks has directly promoted the number of qualified agency services.

In early March, Mai Sheng Meng, director of the Guangdong provincial market supervision bureau, introduced the 230 new medical masks manufacturing enterprises in emergency records. Compared with the provincial level, 26 of them increased by 785%, and 96 new general mask manufacturers. As of March 2nd, the total output of medical masks and respirators totaled 20 million 808 thousand and 900 days, an increase of 665% over the first level.

However, the fever of emergency filing lasted for only a month. The office of the Guangdong provincial drug supervision and Administration issued a notice. According to the current situation of epidemic prevention and control, it was decided that from March 1st, the second categories of emergency medical records needed for the epidemic prevention and control should be stopped in all cities. The notice also pointed out that the application for emergency examination and approval should provide the written instructions for the joint defense joint control materials protection department (the Department) or the market supervision department in accordance with the template.

Xiao Yang said that it would take only a few working days to record the emergency, but he had received more than ten orders last month. But since March, Shenzhen has basically stopped approving it. According to the requirements of the provincial government, if it is more urgent now, it can only go through the emergency examination and approval. The time will be 1 and a half months. The agent fee for applying the mask production license (including emergency examination and approval) + product registration is 150 thousand yuan, including the cost of the test report.

In Liao Ling's view, the period of applying for mask production license is usually 6 to 8 months. Although the time limit for emergency examination and approval is shortened, it is only valid during the epidemic period. If the state has lifted the epidemic situation, it will be useless. Then the formal production license will be applied again. Emergency records in Guangdong, Jiangsu and other places have been turned into emergency examination and approval. The processing cycle has been extended, and the requirements for enterprises are also improving.

According to Liao Ling's current service plan, in addition to requiring customers to have production sites, environmental conditions, production equipment, professional and technical personnel and full-time inspectors, they also require the person in charge of the enterprise to have medical equipment related junior college degree or above, and at the same time should have more than 3 years of medical treatment. Experience in equipment operation and quality management.

In response, Shenzhen Medical Association issued a document that, with the adjustment of epidemic prevention levels, the policy of emergency product production access is also being adjusted. At present, the production license of mask in Guangdong has been recovered to the Provincial Bureau, and the corresponding time limit for examination and approval has increased. Enterprises that have not yet obtained relevant production qualifications need to pay attention. At the same time, with the continuous growth of mask productivity, it is expected that the supply and demand of masks will gradually stabilize in the future, and the demand for masks will gradually return to normal with the improvement of the epidemic situation in the future.

Sterile mask CE certification is very difficult.

The daily economic news reporter noted that at present, the trend of containment of the epidemic has been very clear in China, and the supply of protective clothing such as respirators has been gradually alleviated. But the epidemic is spreading abroad, and overseas demand for respirators and other countries is increasing. Some countries such as Spain and Serbia hope that China can lend a helping hand. Some companies will also focus on the market of global masks.

According to the reporter, if domestic enterprises want to export masks, they need to submit bills of lading, boxes, invoices, import and export operation rights, and cooperate with the third party testing and certification service agencies. They will send their products to the inspection and preparation materials, and submit the declaration materials to the certification mechanism. Only after certification can they be sold in overseas countries. The most popular among them is the CE certification of the European Union and the FDA certification of the United States.

"Since last week, we have received hundreds of enterprises' enquiries about the export of epidemic materials, and more than 90% of the queries are about masks and disinfectant products." Zhang Mo, technical director of consumer goods division of Hangzhou Rui Technology Co., Ltd., told reporters that the export of masks should be carried out in addition to the completion of production licenses and medical device registration in China.

What is the specific export qualification? Zhang explained that, for example, the export companies of medical masks need to cover two kinds of medical devices in the scope of business license, and export masks should complete the certification according to the requirements of the importing countries (including inspection reports, qualification certificates, etc.). Finally, when customs clearance is done, materials such as Bill of lading should be prepared according to customs requirements. Generally, products can be successfully exported.

Xiao Yang said that the company will cooperate with the third party testing institutions to provide certification services for customers. At present, the European Union CE certification (medical mask) offers 15000 yuan. It is necessary to submit the mask name, 3 mask samples, fill in the application form, and the European Union CE certification (ordinary masks) offer 7000 yuan, which requires the business license to scan the samples and samples for 10 working days.

Zhang further emphasized that the CE certification requirements of personal protective clothing masks (domestic KN Series) and medical masks (including disposable medical masks, medical surgical masks and medical respirators) are different, and the CE certification requirements of non sterile respirators and sterile respirators are also different.

"For personal protective masks, for example, there is a large demand for certification in China. In the case of complete detection reports, the domestic certification bodies generally need 2~3 weeks (some large international certification bodies need to wait for 1~1.5 months), the price has risen to 20 thousand ~3 yuan, while in peacetime, the CE certification fee for personal protective equipment is about 10 thousand." Zhang Mo said. In addition, Zhang said that the CE authentication of aseptic masks is very difficult: on the one hand, the EU has implemented the new version of the medical device regulations (MDR), and the material requirements are higher than before. On the other hand, the manufacturers of aseptic masks need to complete the ISO13485 system certification, so there are fewer domestic enterprises that choose to carry out CE certification of sterile medical masks.

Is there any hope of exporting to the United States?

As for FDA certification in the US, Zhang Mo told reporters that companies exporting medical masks should get 510k approval from FDA according to the 510k application process. Personal protective masks (such as N95) need to be certified by NIOSH (National Institute of occupational safety and health). Companies need to send samples to NIOSH labs for testing, and submit technical information. NIOSH will issue certification after both document examination and product testing are approved.

Zhang Mo admitted that at present, small and medium-sized certification bodies in China are not too willing to undertake the masks certification service in the United States: on the one hand, the relevant processes are longer. According to the complete product information of enterprises, the time ranges from 2 months to 10 months. On the other hand, the result is also uncertain. The certification service of FDA medical masks on the market is quoted at 80 thousand ~10 yuan or even higher.

Speaking of the US FDA certification, Xiao Yang also admitted to reporters that it is indeed more stringent than the European Union CE certification. The process of examination and approval is complex, and the audit cycle is longer. I'm afraid it will take about a year to do it, and the cost is higher. The company quoted price of more than 300 thousand yuan, generally do not recommend customers to do.

For the future whether the masks will be exported, the reporter interviewed BYD, Angel and other production masks enterprises. The argument is that first, to protect domestic demand. If there is demand overseas, the export of masks will not be ruled out. Li Wei, director of BYD's chief executive office, told reporters that the government has also purchased some BYD masks and donated them to countries and regions such as Italy and Korea.

"At present, the epidemic situation abroad is grim. We have received urgent demand from foreign customers for masks. Indeed, there are special certification requirements for masks export (such as EU CE, US FDA). At present, we are actively applying for various export certificates, and soon Angel will be exported to foreign countries." Angel relevant responsible person told reporters.

The daily economic news reporter noted that at present, listed companies such as new Lun technology, Yang Pu medical, evergreen shares, and foster pharmaceuticals have indicated that the company or subsidiary involves the export business or qualification of protective clothing such as masks. At the same time, some listed companies, such as Sanfo outdoor, first flight high tech, search special, Han Yu pharmaceutical and so on, indicated that they are stepping up their preparations for the export business of masks, and some companies are still watching.

Zhang said, according to experience, there were more CE consulting companies in the early stage, because the early masks demand mainly came from European countries, and the CE process cycle was shorter, which could quickly achieve the export of mask products to the European Union. However, with the increasing number of products certified by CE on the market, and the United States declared a state of emergency after last week, the demand for masks in the United States increased rapidly. Companies that export American masks to export certification have also changed a lot.

However, in March 22nd, the 12360 customs hotline updated the latest news that Europe and America urgently relaxed the access requirements for masks.

European Union members will be in Official Journal of the EuropeanUnio. N) issued recommendations for compliance assessment and market surveillance procedures for medical devices and personal protective equipment (PPE) during the epidemic. It is worth noting that the content of the proposed emergency measures shows that products requiring notice organization certification can be exported before the completion of the compliance assessment procedure (i.e., before obtaining the CE mark), but to ensure that the certification work will continue. The procurement body is limited to the protection products purchased by the official or authorized bodies of the EU Member States. It can not be marked with CE, but it can only be used by medical staff and can not be sold in the local market. In the follow-up supervision, the relevant market supervisory bodies of the EU Member States will focus on these products without CE logo.

The US Department of health and social services (HHS) announced the need for emergency use of personal respiratory protective devices and in vitro detection kits during the outbreak of the new crown pneumonia outbreak. Manufacturers and strategic reserve agencies can make requests to the US Food and Drug Administration (FDA) to add their products to emergency use authorization.

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