Italy and China General Technology signed an export agreement for 8 million masks
According to Voice of China , On March 16, Beijing time, China General Technology Group Italy and the Italian Government Civil Protection Department reached a supply agreement for 8 million masks, with a total price of 13.6 million euros (approximately 106 million yuan).
Contract-related pictures
Source: Voice of China
In this mask agreement with Italy, the domestic supplier General Technology Group China Medical and Health Industry Co., Ltd. is a collection and storage unit of therapeutic drugs and medical protective materials designated by the Ministry of Industry and Information Technology.
Many overseas Chinese told China Securities Journal that it is currently “hard to find a single mask” in many European countries. A person in the medical industry said that before the outbreak, China accounted for more than half of the world’s annual output of masks and other protective equipment. Among the countries with severe epidemics, South Korea and Japan already have considerable production capacity of masks and protective clothing, so they can basically provide most of the domestic demand. Although there are certain mask and protective clothing companies in European and American countries, most of the manufacturing links have been transferred to Asia, especially China. At present, the existing domestic production is far from meeting the current epidemic prevention needs.
Amid the shortage of masks, European countries have announced bans on the export of protective materials such as masks and goggles. Recently, there has been a surge in export inquiries from overseas about masks and other protective materials. Among them, the demand for inquiry is most prominent in areas with severe epidemics such as Italy and Spain.
Since overseas exports require relevant qualifications and certifications, the demand for many domestic third-party testing and certification services has increased significantly due to the promising prospects for mask exports. The following summarizes the most concerned information about CE certification and FDA certification:
EU CE certification and medical device FDA
EU CE certification: With the entry into force of the Medical Device Directive MDD issued by the European Commission, my country’s disposable polymer medical device products must pass CE certification in order to successfully enter the European Community market. Get the product CE mark. This has largely restricted the export of disposable polymer products and has become a bottleneck for enterprise development and promotion. Therefore, it has become everyone’s consensus that enterprises should engage in CE certification.
FDA medical devices: A wide range of medical devices, ranging from medical gloves to cardiac pacemakers, are all under the supervision of the FDA. In case of injury, the FDA divides medical devices into categories I, II, and III. The higher the category, the more supervision.
For information on whether it is a medical device, you can go to the National Food and Drug Administration Inquiries on the official website of the Supervision Bureau:
samr.cfda.gov/WS01/CL1026/
1 EU personal protective masks (non-medical devices)
The European standard for EU personal protective masks is EN149. According to the standard, masks are divided into three types: FFP1/FFP2/FFP3 Category, need to meet the requirements of the European Union (EU) 2016/425 Personal Protective Equipment (PPE) Directive. The mainstream protective masks are FFP2/FFP3.
Certification process:
1. Product type test report
2. Technical document review
3. Factory quality system review
4. Issuance of CE certificate
5. Product export
Note: You must choose an issuing agency with PPE certification capabilities to apply. After the issuing agency passes the review of the EN149 report Issue CE-PPE certificate.
2 EU personal protective masks (medical devices)
The European standard for medical masks is EN14683. According to standards, medical masks are divided into three categories: TYPE Ia/TYPE II/TYPE IIR. Type Ia is used for patients and other groups during epidemics, and Type II and Type IIR are used for medical staff. Need to meet the requirements of European Union (EU) 2017/745 (new version of medical device MDR). Masks are Class I devices in the EU, but they are divided into two types: non-sterile and sterile.
Non-sterile mask certification process:
1. Prepare technical documents
2. Provide test reports (such as meltblown fabric performance test report and non-woven fabric biological report)
3. Provide a declaration of conformity
4. Designate an EU authorized representative to complete European registration
This is the only feasible method at this stage, and the estimated time is: 2 -3 months
It is very difficult to implement the new version of MDR for sterile masks at this stage. It is estimated that it will take 1-2 years, so it is almost impossible this year
Testing standards
1) Biological evaluation: ISO10993-1, -5, -10 (three conventional items)
2) Bacterial filtration efficiency: EN 14683: 2019 Appendix B
3) Respiratory impedance: EN 14683: 2019 Appendix C
4) Splash resistance: ISO 22609:20>P2: The lowest filtration effect is 94%
P3: The lowest filtration effect is 99%
Korea export Mask qualifications & requirements
Many listed companies promote mask export business
Shangrong Medical stated on the interactive platform on the evening of March 16 that the company has gradually resumed production for export orders on the premise of meeting domestic market demand.
Hanyu Pharmaceutical stated on March 16 that the company has recently received inquiries from customers in North America, EU countries, and Southeast Asian countries, and is currently actively negotiating and advancing. The subsidiary Chengji Pharmaceutical has workshops that meet domestic and foreign medical device standards. At the same time, it is promoting the registration and certification of masks and other protective products in the corresponding international markets as soon as possible, including CE certification of disposable medical masks and disposable protective masks in the EU. U.S. FDA certification and related export filings, etc. It is expected that overseas sales will be achieved after the above work is completed.
Aojiahua stated on the evening of March 16 that the company has been exporting mask products to overseas markets such as Southeast Asia and Japan, and different export destinations have qualification certification requirements for mask products. Differently, the company conducts related trade in accordance with market-oriented principles.
Ogilvy Medical stated that the company has now begun executing overseas mask orders.
According to media reports, Gree Real Estate’s “Gaoge” masks are actively promoting export business. Recently, the company has received purchasing information from customers in EU countries and North America. The company has decided to support global epidemic prevention and control on the basis of meeting domestic demand. While fully ensuring domestic supply, it will turn its focus to the international market in the second half of the year and is expected to export 100 million disposable medical masks throughout the year.
Star Technology announced on the evening of March 16 that the company recently received a notice from the U.S. Food and Drug Administration that the company’s product registration application to the U.S. FDA was approved. Superstar Technology stated that in 2019, the company’s sales of protective masks were less than US$5 million, less than 1% of the company’s operating income in 2019, and had a small impact on the company’s operating performance. The company currently does not have the production capacity for protective masks, and all protective masks are produced outsourced. After the company’s protective mask products are approved by the U.S. FDA, the company will be able to fully sell the above products in the U.S. market. The company is actively promoting the sales of this product in the U.S. market and supporting corresponding production capacity based on order status. The expansion progress and sales scale in the US market are uncertain.
Sanxin Medical announced on the evening of March 15th that the company received a CE declaration of conformity document issued by Luxus Lebenswelt GmbH (code: DE/0000047791) on March 13th. , according to the relevant regulations of the European Union on medical devices, the company’s disposable medical masks have been registered as medical devices in the EU by Luxus Lebenswelt GmbH, the local EU representative in Europe. The company’s disposable medical masks have passed the EU CE declaration of conformity, indicating that the company’s products have the access conditions to enter the EU market. However, the actual sales of the above products depend on the effectiveness of future marketing. The company is currently unable to predict its specific impact on the company’s future performance. Investors are advised to pay attention to investment risks. </p
