Shenyang Baokang Bioengineering Co., Ltd

Let's go! New regulations for mask export! Attached with CE / FDA certification qualification Guide

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链 接 创 造 价 值



With the rapid spread of the overseas epidemic, China's medical supplies such as masks and thermometers have entered the stage of high output. But recently, the quality problems of export masks have been frequently exposed. Yesterday, the Ministry of Commerce, together with relevant departments, announced that the new regulations on the export of medical materials will be implemented from April 1.



商务部:4月1日起!出口医疗物资出新规 




Novel coronavirus pneumonia is a major global disease. The current global epidemic situation is grim. In order to meet the needs of domestic epidemic prevention and control, we encourage enterprises to expand their capacity and export orderly, and provide the international community with help to fight against the epidemic. According to the Central Committee's plan for the new crown pneumonia epidemic leading group, the Ministry of Commerce will establish a working mechanism with relevant departments to strictly control the quality of the relevant medical materials. We will crack down on counterfeiting.


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According to the announcement jointly issued by the Ministry of Commerce, the General Administration of customs and the drug administration, the export of relevant medical materials must obtain the relevant qualifications of the national drug regulatory authorities, and meet the quality standards of the importing countries (regions). At the same time, it is also hoped that foreign purchasers will choose products suppliers that meet the above quality requirements. Once there are quality problems in the export of medical materials, they will be seriously investigated, found, investigated and dealt with together, punished according to law, and will never be tolerated. At present, cross-border e-commerce platforms, including Alibaba and mic, will suspend uploading of Chinese medical products until suppliers submit relevant qualifications or business licenses for medical products, and these products will not be re launched.



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Novel coronavirus reagents, medical masks, medical protective clothing, ventilator and infrared thermometer enterprises should be provided with declaration in writing or electronic declaration (template 1, annex), since April 1st, when the epidemic prevention and control period is special, the Ministry of Commerce issued a notice last night: in order to effectively support the global fight against epidemic situation, ensure product quality and safety, and standardize export order, enterprises that export new coronavirus reagents, medical masks, medical protective clothing, respirators and infrared thermometers should submit written or electronic statements to customs. Nuo's export products have obtained the registration certificate of medical device products in China (see Annex 2 for the relevant registration information), and meet the quality standard requirements of the importing country (region). The customs shall examine and release the medical devices with the registration certificate approved by the drug regulatory department. The above-mentioned supervision measures for the export quality of medical materials will be dynamically adjusted according to the development of the epidemic situation.



微信图片_20200417100622


▲New declaration template for export declaration

According to the Ministry of Commerce, the General Administration of customs and the State Drug Administration, there are 2047 qualified enterprises that have obtained the registration certificate of medical device products in China!


When you inquire, purchase and export, you can carefully find out whether your suppliers are in the compliance list published by three ministries!


To avoid purchasing inferior products, resulting in the goods being checked and detained and ultimately lost!



   Disposable medical masks (752 in total  



省级药监部门一次性使用医用口罩注册信息


微信图片_20200417100656

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   Medical protective masks (150 in total) 



省级药监部门医用防护口罩注册信息


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   Medical surgical masks (523 in total)  



省级药监部门医用外科口罩注册信息

 

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  Medical protective clothing (301 in total)  



省级药监部门医用防护服注册信息(共301家)

 

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   Medical protective masks (23 in total)   



省级药监部门医用防护口罩注册信息


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  Ventilator (62 in total)  



国家及省级药监部门国产呼吸机注册信息


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   Infrared thermometers (236 in total)  



省级药监部门红外体温计(含耳温计、额温枪)注册信息


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Let's talk about the emergency authorization of CE certification of EU and FDA certification of USA

EU CE qualification





As novel coronavirus pneumonia spread rapidly, Italy, France, Germany and other countries fell into the trap. Europe has become the most serious epidemic area. In the process of epidemic prevention and control, due to the serious shortage of medical masks, protective clothing and other medical supplies, Europe has released a huge demand for protective equipment. At present, China has achieved the stage victory of new crown epidemic prevention. As the largest manufacturer of medical protective equipment in the world, both the traditional medical production enterprises and the new enterprises decided to enter this strange field, all decided to use the excess production capacity to sell such products to the European market.


CE certification is essential for export to EU market. At present, a variety of medical CE certificates appear in the market, dazzling. In the wechat group of various industries, you can often see someone issue a so-called CE certificate. Please help to identify the authenticity. In order to help you better, let's talk about specific identification methods.


There are many ways to check the authenticity of CE certificate, first of all, the simplest one. Large announcement organizations will open the window to query certificates on their own official websites. Of course, this method is only applicable to the situation that the issuing organizations just provide query services. For institutions that do not open the certificate query service, it will not work. So for this kind of situation, when we get a medical CE certificate, how can we identify it?


We can still try to start with the issuing institution of this certificate and go to the official website of the European Union to check whether it has the corresponding certification quality of the European Union Medical Device Directive MDD 93/42/EEC or the MDR medical device regulation (EU) 2017/745 and the personal protective equipment authorization (EU) 2016/425.



Inquiry address of institutions authorized by MDD 93 / 42 / EEC medical device directive on EU official website:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

MDR (EU) 2017 / 745 medical device regulations authorized institutions inquiry address:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

European Union official website (EU) 2016 / 425 personal protective equipment authorized institution inquiry address:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=15550


It can be seen from the official website of the European Union that there are 56 notified bodies authorized by the MDD 93 / 42 / EEC medical device directive. The specific list of institutions, the announcement number and the scope of their qualified products are listed in detail.




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Since May 26, 2020, the MDR (EU) 2017 / 745 medical device regulation will formally replace the current MDD medical device directive of the European Union and be enforced. Similarly, it can be found on the official website of the European Union that there are only 12 announcement institutions with MDR authorization.

Therefore, if the medical CE certificate issuing agency you have is not included in the above list, it means that it does not have the EU certification qualification for medical products, let alone the issuance of CE certificate. Then, it is regrettable to say that the "CE certificate" you have obtained is invalid.

In addition, we can also start from the process of CE certification of medical device products to analyze and complete the identification.

Take the mask as an example. First, confirm whether the mask belongs to medical equipment. Masks are divided into medical masks and protective masks. If they are the latter, they are not medical devices and do not need to meet the requirements of EU medical regulations. CE certification can be completed according to PPE personal protection directive. If it is a medical mask, it needs to be certified according to the medical device regulations. For medical masks, we need to further confirm whether it is sterile. If it is a sterile medical mask, which belongs to a class of medical products with sterilization in the EU, it must be CE certified in accordance with the medical device directive / regulation MDD / MDR, which must be participated by an authorized announcement agency. If it is a non sterile medical mask, it is a CE self declaration in accordance with the medical device directive / regulation MDD / MDR. The enterprise does not need to pass the certification of the notified body. After the corresponding documents and test reports are prepared, it can complete the declaration of conformity by itself.

As far as the current situation is concerned, in view of the difficulty of CE certification of sterile medical masks and the long time required, most manufacturers have chosen non sterile medical masks to produce and complete the certification.

We need to make a point here. Since it is the manufacturer who claims CE conformity, how can the notified body issue CE certificate? If CE certificate cannot be issued, what is the so-called certificate that many enterprises get? Let's look at some templates:



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Please study the content carefully: "verification of the presence of the technical files in regulations of the Medical Devices Directive..." It means that this certificate proves that the organization has reviewed that the enterprise has prepared technical documents according to the requirements of medical device regulations.


US FDA



The management of medical devices in the United States is centralized in the device and radiation health center (CDRH) of the food and Drug Administration (FDA). Medical masks, thermometers (including ear temperature gun, forehead temperature gun, general electronic thermometer and mercury thermometer) and protective clothing and isolation clothing used in medium to high risk are all class II medical devices, and 510 (k) applications are required. Although the N95 mask can be exempted from 510 (k), it must first obtain the N95 certificate from NIOSH of the American Centers for Disease Control and prevention. FDA only has prescription and over-the-counter for all medical devices, and there is no difference between home use and professional medical staff.

The application process of 510 (k) is as follows:


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Generally, it takes 8-10 months for a product to start 510 (k), prepare for testing and various documents until the final audit is completed, while the time for the initial application of the enterprise is usually longer.


In addition to 510 (k), FDA requires all medical device enterprises to carry out the establishment registration and product listing, which is no exception for the products authorized for emergency use. For all overseas enterprises, they should get Dun Bai's code before registration. The code is issued by Dun Bai's agent in China. The free code can be obtained in about 30 days. After obtaining Dun's code, it will take about 1-2 weeks to complete the site registration and product listing.


No matter 510 (k), site registration or product listing, FDA will not issue any certificate to the enterprise, only the data in the FDA database of the United States will prevail. In other words, all kinds of certificates with Eagle mark that you have seen have no effect.


At present, the new crown epidemic in the United States shows an obvious outbreak trend, all kinds of medical supplies are also becoming tense. The U.S. Food and Drug Administration (FDA) began to investigate the potential shortage of medical devices in early February of this year (2020). In response to the shortage of various medical devices, the FDA issued various emergency use authorization (EUA). At present, the products that can apply for EUA are mainly unlisted N95 masks, unlisted new coronavirus diagnostic reagents, unlisted alcohol hand sanitizer products, non-invasive remote monitoring systems that have been listed but need to be expanded, and listed and unlisted respiratory equipment.


New crown testing reagent: the first is the diagnostic reagent. FDA has released the second version of the guiding principles for this product. The first edition of the guidelines focuses on the application of EUA for self-developed test methods of clinical laboratories in the United States, while the second edition includes detailed guidance for manufacturers to submit EUA applications. The content of EUA application is similar to that of 510 (k), and the description, intended use, performance evaluation report, clinical evaluation scheme, stability test scheme, label identification, etc. of test reagent shall be submitted. Because of the emergency approval, FDA also requires enterprises to provide face sheets for patients and professionals. At present, Haihe consulting has completed the EUA application for the colloidal gold method of the new coronavirus gel detection kit.


Mask: the next most urgent one is mask. There are many kinds of masks in the United States. Haihe has also held a special online seminar on the registration ways of masks, and explained the listing ways of different types. The FDA also issued two rounds of EUA notifications for masks.



The first round of EUA allows the direct use of masks that meet the following conditions:

★ Export of masks -- Guide to Customs Technical Trade Measures ★




1、 Exit clearance tips


1. Preconditions for customs declaration


Registration code of consignee and consignor (charity can be temporary code), paperless customs clearance legal person card is required


2. Export qualification


For the production and sales units and domestic consignors, except for meeting the qualification requirements of domestic production and market circulation, China Customs has no special qualification requirements.


3. Export declaration requirements


(1) Commodity classification: except for special circumstances, most masks should be classified into tax No. 63079000.


(2) Inspection and quarantine: the mask is an illegal inspection product, and the inspection and quarantine items need not be filled in at the time of declaration. According to the Intergovernmental inspection agreement signed by our government and relevant countries, the products exported to Iran and other few countries need to be inspected before shipment according to the regulations.


(3) Duty collection and exemption: if the export materials are of trade nature, the nature of the collection and exemption shall be declared for general taxation, and the method of the collection and exemption shall be declared and taxed according to the regulations; if the nature of the collection and exemption is donation, and the domestic consignor is a trade agent, charity, etc., the nature of the collection and exemption may not be filled in, and the method of the collection and exemption shall be declared and exempted completely.


(4) Prohibition and restriction management: at present, the Ministry of commerce does not set up trade control requirements for masks, nor does the Chinese customs have requirements for port inspection of supervision certificates for protective materials.


(5) Declaration specification: fill in the commodity name and content of ingredients according to the declaration requirements; if the material is not produced in China, the country of origin shall be filled in according to the actual country of production.


4. Export tax refund


The export tax rebate rate of masks is 13%.


5. Sino US tariff exclusion and levy


U.S. companies can apply to exclude the import tariff of face masks, but only a few have been granted exemption. See the website of USTR at https://ustr.gov/.


6. Fast customs clearance guarantee


In case of system failure such as single window in material export declaration, you can contact the on-site customs for emergency disposal, or call the customs 12360 hotline for consultation.


*The following contents are collected and collated according to relevant domestic and foreign government agencies, professional websites and news reports, for reference only. The specific content shall be subject to the requirements of relevant administrative departments and foreign official institutions.

2、 Preparation before export


1. Make clear the classification of masks


According to the purpose, there are two types of masks in foreign countries: personal protective masks and medical masks. The qualifications and materials required by domestic export and trade enterprises are as follows:


(1) Business license (business scope has relevant business contents).


(2) Enterprise production license (production enterprise).


(3) Product inspection report (manufacturer).


(4) Medical device registration certificate (not required for medical use).


(5) Product manual (provided with the product), label (provided with the product).


(6) Product batch / No. (outer package).


(7) Product quality safety book or certificate (to be provided with the product).


(8) Product sample picture and outer package picture.


(9) A trading company shall obtain the registration of the consignee and consignor of the Customs for the record.


2. Qualification certificate of domestic export mask manufacturer


Enterprises that have the right to import and export the general masks for personal protection or industrial use other than those under the management of medical devices may export them directly on their own.


For the production of masks under the management of medical devices for export, China customs does not need the enterprise to provide relevant qualification certificates, but the general import Congress requires the manufacturer to provide three certificates to prove that the imported products have been legally listed in China, as follows:


(1) Business license (the business scope includes medical devices, and non-medical grade items are not required).


(2) Record certificate or registration certificate of medical device products.


(3) Manufacturer's test report.


Production enterprises have the right of import and export, and can export by themselves. If they do not have the right of import and export, they can sell through foreign trade agents.


3. Basic qualifications for domestic trade enterprises to export


(1) Obtain the business license from the market supervision department and increase the business scope of "import and export of goods, technology and agent".


(2) To obtain the right of import and export from the commercial department, you can directly apply on the unified platform of the business system of the Ministry of Commerce (http://iecms.mofcom.gov.cn/), and submit materials online.


(3) Apply to safe for permission to open a foreign exchange account.


(4) Handle the customs registration of the consignee and consignor of import and export goods.

3、 Access conditions for national masks (product access conditions)


1. United States


Necessary information: B / L, packing list, invoice.


Personal protective mask: it must be certified by NIOSH test, i.e. National Institute for occupational safety and health.


Medical mask: must obtain FDA registration permission.


2. EU


Necessary information: B / L, packing list, invoice.


Personal protective mask: the European standard of personal protective mask is en149. According to the standard, the mask is divided into three categories: ffp1 / FFP2 and ffp3. All masks exported to EU must obtain CE certificate. CE certification is a compulsory product safety certification system implemented by EU, which aims to protect the life and property safety of EU people.


Medical mask: the corresponding European standard of medical mask is en14683.


When the products are sold in the European Union, the free sale certificate of the European Union shall be issued. After having CE mark and being registered in the European Union as required by relevant directives, Chinese manufacturers do not need the free sale certificate for exporting to the European Union.


3. Japan


Necessary information: B / L, packing list, invoice, foreign manufacturers must register manufacturer information with PMDA.


Packaging requirements for respirators: 99% of the words "ウィルスカットト" shall be printed on the packaging


PFE: 0.1um particle filtration efficiency


BFE: bacterial filtration rate


VFe: virus filtering rate


Quality standard of respirator:


(1) Medical protective mask: it complies with the compulsory standard of China GB 19083-2010, and the filtration efficiency is ≥ 95% (test with non oily particles).


(2) N95 mask: certified by NIOSH, the filtration efficiency of non oil particles is ≥ 95%.


(3) Kn95 respirator: it meets the mandatory standard of GB 2626, and the filtration efficiency of non oil particles is ≥ 95%.


4. Korea


Necessary information: B / L, packing list, invoice, business license of Korean importer.


Personal protective mask standard: KF (Korean filter) series is divided into kf80, kf94 and kf99


Executive standard and specification: MFDs Notice No. 2015-69


The regulatory threshold for the access of medical devices in Korea is basically classified into categories I, II, III and IV, and the license holder is Korean company. The Korean consignee needs to go to the Korean pharmaceutical Traders Association of the Korean drug administration. The website for filing the import qualification in advance (no fail): www.kpta.or.kr.


5. Australia


Necessary information: B / L, packing list, invoice.


It must be registered with TGA in Australia and meet the standard specification: as / NZS 1716:2012, which is the respiratory protection device standard in Australia and New Zealand.


TGA is the abbreviation of Therapeutic Goods Administration, full name is therapeutic goods administration. It is the supervision organization of therapeutic goods (including drugs, medical devices, gene technology and blood products) in Australia. In Australia, medical devices are divided into class I, is and IM, IIA, IIb and III. The classification of products is almost the same as that of EU. If the products have obtained CE mark, the product category can be classified according to CE.


4、 Brief process of registration and certification in different countries


1. NIOSH certification


It needs to be implemented in accordance with NIOSH's guidelines. Enterprises need to send samples to NIOSH's Laboratory for testing, and submit technical data (including some data of quality system) to NIOSH's document review. NIOSH can only issue approval documents if both the document review and test are passed. NIOSH classifies its certified particle respirators into 9 categories, and the specific tests are conducted by npptl (National Personal Protective Technology Laboratory) under NIOSH. The main test indexes include expiratory resistance test, expiratory valve leakage test, inspiratory resistance test and filtration efficiency test.



2. FDA registration


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3.欧盟CE注册

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4.日本PMDA注册

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1) Preparation stage. Determine product classification (I, II special control, II control, III, IV) and product jmdn code, and select MAH (Japanese holder);


(2) The manufacturer registers the plant with PMDA;


(3) Class II special control products shall apply for QMS factory audit to PCB of the authorized certification authority, and other class II products and class III IV products shall apply for QMS factory audit to PMDA and obtain QMS certificate;


(4) Apply for pre market approval certificate, special class II control is issued by PCB, other class II products and class III IV product control are issued by MHLW (Ministry of health, labor and welfare);


(5) Payment of application fee;


(6) Rectification of registration documents and approval of registration;


(7) All kinds of products can only be imported and sold after MAH informs rbhw of import registration.


5. KFDA registration in South Korea


The Ministry of health and welfare (MHW), which is the most important health care department, is mainly responsible for the management of food, medicine, cosmetics and medical devices. According to the medical device law, the food and drug safety department under the Ministry of health and welfare of South Korea is responsible for the supervision of medical devices. KFDA registration process is as follows:


(1) Determine product classification (I, II, III, IV) and select KLH (Korean holder);


(2) Class II products need to apply for kgmp certificate and accept on-site audit. Class II products are generally authorized third-party auditors and obtain kgmp certificate;


(3) Class II products need to send samples to MFDs authorized laboratories in Korea for Korean standard test;


(4) KLH shall submit technical documents (test report, kgmp certificate, etc.) to MFDs for registration and approval;


(5) Payment of application fee;


(6) Rectification of registration documents and approval of registration;


(7) Appoint Korean agents and distributors to sell products.

6. TGA registration in Australia


According to the Australian Therapeutic Goods (medical devices) regulations 2002, the medical devices in Australia are divided into class I, is and IM, IIA, IIB, III. The classification of products is almost the same as that of EU. If the products have obtained CE mark, the product category can be classified according to CE. If the CE certificate issued by the notified body of the European Union has been obtained, it can be recognized by the TGA and can be used as an important registration data to meet the Australian safety regulations.

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5、 Comparison of technical standards of masks in different countries (for reference of manufacturers)

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6、 Technical standards of masks in various countries (for reference of manufacturers)

序号

标准号

标准名称

状态

发布时间

国际

ISO 22609:2004

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积,水平注射)

现行

2004/12/3

欧盟

EN 136-1998

呼吸保护装置.全面罩.要求,试验,标记。

现行

1998/1/1

EN 140-1998+AC-1999

呼吸保护装置.半面罩和四分之一面罩.要求,试验和标记。

现行

1998/9/1

EN 143-2000

呼吸防护装置.微粒过滤器.要求,试验,标记。

现行

2000/2/1

EN 149-2001

呼吸防护装置.颗粒防护用过滤半面罩.要求,检验和标记。

现行

2001/4/1

EN 529-2005

呼吸保护装置.选择,使用,保养和维修的建议。

现行

2005

EN 12942-1998

呼吸保护器.带全面罩,半面罩和四分之一面罩的鼓风过滤装置.要求,检验,标识。

现行

1998

EN 14387-2004+A1-2008

呼吸保护装置.气体过滤器和组合过滤器.要求、测试、标记。

现行

2004/1/1

EN 14683-2019

医用口罩 要求和试验方法。

现行

2019/3/1

美国

ASTM F1862/F1862M-2017

医用口罩抗人工合成血渗透的标准试验方法(已知速度下固定体积的水平投影)。

现行

2017

ASTM F2100-2019

医用口罩材料性能标准规范。

现行

2019

ASTM F2101-2019

用金黄色葡萄球菌生物气溶胶评价医用口罩材料的细菌过滤效率(BFE)的标准试验方法。

现行

2019

ASTM F2299/F2299M-2003(2017)

用胶乳球测定医用面具材料粒子渗透性初始效率的标准试验方法。

现行

2003

澳大利亚

AS/NZS 1715:2009

呼吸保护设备的选择,使用和维护。

现行

2009/2/6

AS/NZS 1716:2012

呼吸保护装置。

现行

2012/2/13

日本

JIS T 8062:2010

预防传染性病原体的防护服.面罩.防止人造血浆渗透的试验方法(确定容量,平行注射)。

现行

2010/5/25

JIS T 8159:2006

呼吸防护设备的选择、使用和维护指南。

现行

2006/4/25

JIS T 8159:2006

呼吸保护装置泄漏率试验方法。

现行

2006/2/20

韩国

KS M 6673-2008

防尘口罩

现行

2008/2/22

KS K ISO 22609-2018

传染试剂防护服.医疗面罩.防人造血渗透的试验方法(固定容积、水平喷射)。

现行

2018/11/14

*In case of dynamic adjustment of the above technical standards, the official release of the relevant standards management organization shall prevail.








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