A few days ago, the Chinese Ministry of Commerce, the General Administration of Customs, and the State Food and Drug Administration jointly issued a document to import coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers from China from April 1, 2020. Chinese factories And when the trading company purchased from the factory declares to the Chinese customs, it must provide a written or electronic statement, promising to export the coronavirus detection reagents, medical masks, medical protective clothing, ventilator, the infrared thermometer has obtained the registration of Chinese medical device products The certificate also meets the quality standards of the importing country (region).
China Customs will pass customs clearance only with the medical device product registration certificate approved by the drug regulatory authority. The above-mentioned quality supervision measures for the export of medical supplies will be adjusted dynamically according to the development of the epidemic situation.
Share a story about one Chinese trader BW cooperates with:
“I have millions of coronavirus detection reagent orders exported to the United Kingdom, and I nearly signed the contract. I heard this news yesterday, and I almost fainted.” On April 2, the agent Zhang Jie said to BW, he and upstream The manufacturers are very nervous.
A source disclosed to BW that after the introduction of the regulations, many companies responded to the drug regulatory department with relevant information. When the person in charge of the company contacted a local drug regulatory department, they cried directly.
In fact, as soon as the relevant regulations were introduced, a series of chain reactions appeared. Uncertified factories and traders attracted a lot of overseas importers at low prices, but manufacturers and trade could not be exported. Agents squeezed a bunch of orders in hand, and then who held a certificate of Chinese suppliers ’products. their prices have jumped.
On April 2nd, Zhang Jie saw that many manufacturers and dealers’ quotations could be described in horror. The price of each ventilator distributor skyrocketed 100,000 RMB, and the coronavirus detection kit rose from 23 RMB to 42 RMB.
At present, he is more expecting the relevant regulations to make corresponding adjustments to the export of anti-epidemic materials. It is understood that many industry associations have proposed that China’s national regulatory authorities should strictly investigate some unqualified production enterprises so that many enterprises ‘export is blocked, many importers’ goods cannot be shipped, and many importers have already paid deposits, even The full payment, waiting for shipment, of course, this part of the importer, fancy the low price, and ignore the qualifications of the supplier so that he has fallen into great risks, resulting in a lot of trade enthusiasm.
Reduce your losses as low as possible.
According to the data from the State Food and Drug Administration of China, the latest statistics found that the current China-wide export-qualified product specifications:
23 new coronavirus detection reagents;
150 medical protective masks,
523 medical surgical masks,
752 disposable medical masks;
301 protective clothing;
62 ventilators;
236 infrared thermometers.
At present, the Medical Device Industry Association and the China Business Association are all sorting out and consulting the sales of some companies. According to preliminary statistics, only diagnostic reagents involve sales of RMB 3-40 billion.
Medical supplies imported from China have increased prices
On the one hand, the goods that have received the payment cannot be shipped, on the other hand, the foreign inquiry is increasing, Zhang Jie began to find suppliers with domestic registration certificates to negotiate, but found that the price generally rose sharply, including kits, masks, ventilators, etc. And the waiting period for orders is very long, many of them are arranged one month or even 45 days later.
Zhang Jie said that there are currently three types of kits exported from China, one is colloidal gold, the other is a nucleic acid, and the third is fluorescent PCR. Nucleic acid detection requires the use of a machine, the time for the results is relatively slow, and it must be transported at minus 20 degrees cold chain; fluorescent PCR also needs to be done on the machine, specimen collection operations have certain requirements, and the screening speed is relatively slow.
The colloidal gold kit can be stored at room temperature, and the results can be obtained in 15 minutes, without the need for machine operation. Because of its convenient operation and wide use by the crowd, the current export volume is relatively large, which has also been confirmed by multiple testing reagent suppliers.
It is worth noting that colloidal gold is used for the screening of suspected patients with new coronavirus, and the two antibody indicators of IgM and IgG are detected. The final diagnosis is still using nucleic acid detection reagents.
Zhang Jie said that at present, there are only five domestic colloidal gold kit companies that meet the new export regulations, namely Guangdong Hexin Health Technology Co., Ltd. (monoclonal antibody products, product prices and export demand are much lower than the other four double antibodies), Guangzhou Wanfu Biotechnology Co., Ltd., Nanjing Nuoweizan Medical Technology Co., Ltd., Innotech (Tangshan) Biotechnology Co., Ltd., Zhuhai Livzon Reagent Co., Ltd. But after the new regulations came out, no company was able to provide goods, and prices rose sharply.
Among them, the ex-factory price of Guangzhou Wanfu Biotechnology Co., Ltd. has always been the most expensive quotation, and it is not available now. After the order is scheduled for 20 days, Zhuhai Livzon Reagent Co., Ltd. is also unable to supply, Innotech ( Tangshan) Biological Technology Co., Ltd. has stopped quoting, and the price of Nanjing Nuoweizan Medical Technology Co., Ltd. has increased from 23 yuan to 6 US dollars (about 42 yuan) on April 2.
“A nucleic acid reagent manufacturing company with a registration certificate quoted 45 RMB 100,000 units ，42RMB 200,000 units, and 200,000 units ，the rate rise from 42RMB to be 48RMB p after the policy came out. “Zhang Jie said.
BW also verified the above price increase news with some export-qualified diagnostic reagent companies. Most of them did not increase the price and are still waiting to see.
The ventilator is a vital medical device that can prevent and treat respiratory failure, reduce complications, save and extend the life of patients.
Import ventilator from China, export declaration requirements
Commodity classification
| commodity | Explanation | Product Number |
| Ventilator | Ozone therapy device, oxygen therapy device, spray therapy device, artificial respirator or other therapeutic breathing apparatus | 9019.2000 |
Prohibition of import of ventilator from China
According to the Announcement No. 5 of 2020 of the General Administration of Customs and the State Administration of Drug Administration of the Ministry of Commerce of China, a written or electronic statement must be provided, promising that the exported product has obtained the China Medical Device Product Registration Certificate and meets the quality standards of the importing country (region).
It is recommended that importers never conceal the product name, apply for customs declaration or use illegal channels. At present, no trading and freight forwarding company can guarantee the success of the customs declaration. If there is no legal certificate, no freight forwarding company or trading company will fight against the instructions of the Chinese government. If you violate this rule, freight forwarders and foreign trade companies and factories will be subject to huge penalties.
If the supplier you are looking for has a registration certificate but no export rights, contact BW and use BW’s trading company with Class II medical qualification for export.
Customs entry conditions for imported ventilator from China
Import ventilator from China to the United States
You must obtain the FDA registration certification from the US Food and Drug Administration before you can sell in the US domestic market, and the FDA registration certificate must be processed in the US mainland. It is recommended that companies entrust a US local agent when applying. The United States announced that it will abolish import tariffs on some medical supplies, including ventilators, starting March 11. China-US Customs Inquiry Address:
https://www.guanwuxiaoer.com/taxes.php
The management of medical devices by the US FDA is carried out through the Center for Devices and Radiological Health (CDRH), and its classification and management requirements for each medical device are extremely strict.
According to the different risk levels, FDA classifies medical devices into three categories (I, II, and III), and ventilators belong to category III high-risk medical equipment.
Ventilators listed in the United States must submit all technical and clinical documents to the FDA in steps of 510 (k) in accordance with enterprise registration, product listing, general control, and special control, with a view to certifying the safety, reliability and Various parameters, performance and many other aspects finally proved through rigorous demonstration and testing that the model applying for certification can fully meet the requirements of FDA.
FDA 510 (k) is one of the main ways for medical devices to be listed in the United States. The vast majority of Class II medical devices and some Class I and III medical devices are cleared and listed through this channel.
The 510 (k) document is a pre-market application document submitted to the FDA. The purpose is to prove that the product applied for marketing and the product that has been legally sold in the US market are substantially equal in safety and effectiveness, that is, equivalent Instruments (substantially equivalent).
Applicants must compare the device applying for marketing with one or more similar devices on the US market to draw and support the conclusion of equivalent devices. The FDA has a basic requirement for the information that must be included in the FDA 510 (k) registration document. Its contents are rough as follows:
How to proceed and apply for the US FDA 510 (k):
1. Application Letter
This part should include the basic information of the applicant (or contact person) and the company, the purpose of FDA 510 (K) submission, the name and model of the device to be marketed, and the classification information, the name of the product (Predicate Device) for which a substantial equivalent comparison is made and its 510 (k) number.
2. Directory
That is a list of all information (including attachments) contained in the FDA 510 (k) document.
3. Authenticity guarantee statement
FDA has a standard sample
4. Name of equipment
Namely the product common name, FDA classification name, product trade name.
5. Registration number
If the company has already registered the company when submitting the FDA 510 (k), the registration information should be given. If it is not registered, it should also be indicated.
6. Classification
That is the classification group, category, management number and product code of the product.
7. Performance standards
The mandatory or voluntary standards that the product meets.
8. Product identification
Including enterprise packaging logo, instruction manual, packaging accessories, product labeling, etc.
9. Substantial equality comparison (SE)
Choosing the right product for comparison is a key step in the 510 (K) application. When comparing, the following aspects should be considered: The enterprise must provide sufficient information to prove that the device applied for marketing and the device being compared are substantially equal (SE), otherwise, the 510 (k) application will not pass.
10.510 (k) summary or statement
Summary of application documents and conclusions supporting equivalent devices.
11. Product description
Including the intended use of the product, working principle, power source, components, photos, process drawings, assembly drawings, structural schematics, etc.
12. Product safety and effectiveness
Including various design and test materials.
13. Biocompatibility
Biocompatibility refers to a concept of various biological, physical, chemical and other reactions produced after the interaction between materials and organisms. Generally speaking, it is the degree of compatibility of the material with the human body after implantation, that is to say, whether it will cause toxic effects on human tissue.
14. Pigment additives (if applicable)
15. Software verification (if applicable)
16. Sterilization (if applicable)
Including description of sterilization methods, sterilization verification product packaging and labeling, etc.
Import ventilator from China to the EU
Must obtain EU CE certification and comply with technical regulations: MDD 93/42 / EEC or MDR (EU) 2017/745.
It is recommended to find a notified body recognized by the EU for testing.
How to verify and identify the ventilator CE certification imported from China:
1. The official website of the European Union MDD 93/42 / EEC Medical Devices Directive:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
2. From May 26, 2020, the MDR (EU) 2017/745 medical device regulations will officially replace the current mandatory MDD medical device directive in the EU, which can also be found on the EU official website.
EU official website MDR (EU) 2017/745 medical device regulations authorized institutions to query the address:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
EU CE certification qualification discrimination reference，Click below：
Special reminder: What impact does the EU MDR implemented on May 26, 2020, have on CE certification MDD?
● At present, most of the CE certificates are tested according to MDD requirements, and face the problem of MDR replacement after January;
● Not all the announcement agencies authorized by MDD are MDR authorized announcement agencies, and the selectivity of CE certification audit institutions is reduced;
● The audit requirements of MDR are more complicated than MDD, and the certification period must be greatly extended;
● CE certification fees may increase significantly;
● The EU has stricter regulations on medical equipment.
Import ventilator from China to Japan
If you need to put products on the market, you must meet Japan’s Pharmaceutical and Medical Device Act (PMD Act). Under the requirements of the PMD Act, the TOROKU registration system requires foreign manufacturers to register manufacturer information with PMDA.
Japan Comprehensive Agency for Pharmaceuticals and Medical Devices (PMDA)
Website: www.pmda.go.jp
Import ventilator from China to South Korea
The legal threshold for the admission of medical devices in Korea is basically classified as Class I, II, III, and IV. The license is a Korean company (License holder). The Korean consignee needs to go to the Korea Pharmaceutical Traders Association. Qualifications.
Korea Pharmaceutical Traders Association
Website: www.kpta.or.kr
Import ventilator from China to Australia
It must be registered by TGA in Australia. TGA is the abbreviation of Therapeutic Goods Administration. The full name is Therapeutic Goods Administration. Australia divides medical devices into Class I, Is and Im, Class IIa, IIb, and Class III, which are exemption, filing, and registration. Regardless of the type of medical device, it must be approved by the Australian government before it is marketed, meets the basic requirements of medical devices, and is reviewed in accordance with the compliance review process.
Special reminder: Australia has reached a mutual recognition agreement with the EU. This means that the conformity assessment certificate issued by TGA is also recognized by the EU, and TGA also recognizes the EU CE certification. Users who have obtained CE certification can submit CE certificates and related materials to obtain a TGA certificate.
If the product has been registered or filed, the manufacturer’s replacement of the distributor has no effect on it. After the approval of registration of foreign products, regular registration is required once a year to indicate whether the product model, performance and quality have changed. TGA is solely responsible for evaluating the conformity of medical devices and charges a certain fee. The relevant fee amount can be found on TGA’s website.
TGA website: https://www.tga.gov.au/
How to import ventilator from China: supplier selection, quality control, risk
1 How to find and purchase ventilator from China:
In order to reduce overseas buyers encountering illegal and non-compliant Chinese suppliers, and spending a lot of time unable to find legal suppliers, BW announced to global buyers free of charge that China National Food and Drug Administration has legal export licenses from 4.2. Supplier List:
Click here todownload the suppliers’ list of the ventilator from China, this is the fastest way to meet the real Chinese ventilator supplier.
Using BW’s logistics and inspection services will be the biggest support for BW. Let BW become your logistics supplier for Asian shipments, and you will get more surprises.
How to control the quality of the ventilator imported from China?
Because of the current special epidemic situation, the production and quality of the factory are very unstable, so we choose BW’s quality control service. We arrange a quality supervisor to go to the factory for pre-shipment inspection to ensure your import business reputation.
Risks of purchasing and importing ventilator from China:
BW recommends deposit 30% or 50%, do not conduct a full transaction
Choose the BW inspection service to avoid quality problems.
How to ship ventilator from China:
Transportation route:
Sea freight: Southeast Asia, Japan, South Korea, we recommend shipping by sea.
Air Freight: Airfreight for the delivery of anti-epidemic materials from China, the waiting time for goods in the warehouse, the customs declaration time, the customs clearance time for inspection, and the waiting time for take-off are very long. Please arrange the shipment reasonably according to the order situation of different buyers. However, shipping ventilator from China by air is still the preferred logistics solution
Be sure to choose FOB terms!
FOB suppliers will declare to China Customs through their own companies.
They must provide all the customs declaration information corresponding to their company. If their customs documents or any report is illegal or wrong, their 13% tax refund will be affected.
The Chinese government will refund 13% of the tax refund to Chinese exporters, about 55 days after the goods are exported. Therefore, if the supplier needs to get the money, they must provide all legal and compliant operation procedures and customs documents.
What are the risks of shipping ventilator from China?
If you adopt the EXW term, you will be attracted by the low price, but when you declare the goods. You will find that the export of medical gloves has encountered problems because China Customs is currently very strict with the export declaration of medical protective equipment.
For all cargo transportation under EXW terms, overseas buyers find their own freight forwarders, and many freight forwarders cannot provide medically qualified export agents. So all of the export risks is in the buyer,
CIF: If you use the CIF because the logistics freight is included in the unit price of the product, you do not know how much freight is spent, which is not conducive to the cost control of your supplier.
And the supplier and his freight forwarder plus more profits in logistics costs. Since all the Chinese airlines recently, the air freight billing is based on the customs declaration day’s price, many importers complain about the high EXW and CIF air freight costs, and finally chose BW as their logistics supplier to avoid loss of each cargo Thousands of dollars in logistics losses.
And CIF terms you cannot control which company the supplier uses to submit the medical product declaration. At present, many overseas buyers who make CIF term contact BW when the goods cannot be shipped and the customs declaration fails. At this time, we cannot assist. too late.
Choose BW, which has a strong Chinese network and covers the network in the whole Asian. Choose BW as their freight forwarder in China.
A brief analysis of technical standards of the ventilator shipping from China：
In particular, the American Standard requires that the working pressure control of the infant ventilator should be accurate to ± 2cm H2O in the whole range, while another ventilator should be accurate to ± 5cm H2O. Compared with the American standard, the Chinese standard does not comply with the requirements of infant ventilators and other ventilators. The accuracy of the reading is required to be ± (2% full scale + 4% actual reading). The other is that the Chinese standard’s requirement for alarm sound is the latest standard implemented, while the equipment in the United States is tested according to the claimed standard.
| country / region) | Standard | standard name |
| United States | ANSI / ASTM / IEC 60601.2.12-2009 | Medical electrical equipment Part 2-12: Particular safety requirements for lung ventilators. Intensive care ventilators for intensive care according to ASTM international standards |
| ANSI / ASTM / ISO 10651-4-2002 | Medical lung ventilator. Part 4: Particular requirements for artificial ventilator for operator control | |
| ANSI / ASTM / ISO 10651-5-2006 | Particular requirements for basic safety and basic performance of medical lung ventilator. Part 5: Pneumatic emergency respirators | |
| ANSI / NFPA 1981-2006 | Standard for open circuit self-contained ventilators for fire and emergency services | |
| ASTM ANS / IEC 60601-2-12-2001 | Medical electrical equipment Part 2-12: Particular requirements for the safety of ventilators-Ventilator for emergency use-Approved by ASTM International as a US national standard with differences | |
| ANSI / ASTM / ISO 10651-4-2ASTM ANS / IEC 60601.2.12-2001 | Medical Electrical Equipment Part 2-12; Particular Requirements for Lung Ventilator Safety-Critical Care Ventilator Passes American National Standard Certification, Deviations Meet ASTM International Standards | |
| ASTM ANSI / ISO 10651-4-2002 | Ventilator | |
| ASTM ANSI / ISO 10651-5-2006 | Specific requirements for basic safety and basic performance of medical ventilators |
| EU | EN 794-3-2009 | Lung ventilators. Part 3: Particular requirements for emergency ventilators and transport ventilators |
| EN ISO 80601-2-12-2011 | Medical electrical equipment. Part 2-12: Particular requirements for basic safety and basic performance of critical care ventilator | |
| EN ISO 80601-2-72-2015 | Medical electrical equipment Part 2-72: Particular requirements for the basic safety and basic performance of ventilators in ventilator-dependent family healthcare environments | |
| EN 14048-2002 | Determination of degradation in the final packaging bio gasification oxidizing medium packaging material closed ventilator oxygen measurement | |
| EN 14529-2005 | Self -contained open-circuit compressed air ventilator with half-mask type mask containing a positive pressure respirator controlled by a demand valve | |
| EN 60601-2-12-2006 | Particular requirements for the safety of medical electrical equipment lung ventilator. Part 2-12: Critical care ventilator |
| Japan | JIS T 7204: 1989 | Medical ventilator |
| Korea | KS C IEC 60601-2-12-2011 | Particular requirements for the safety of lung ventilators for medical electrical equipment. Part 2-12: Critical care ventilators |
| Australia | EN 794-3-2009 | Lung ventilators. Part 3: Particular requirements for emergency ventilators and transport ventilators |
| EN ISO 80601-2-12-2011 | Medical electrical equipment. Part 2-12: Particular requirements for basic safety and basic performance of critical care ventilator | |
| EN ISO 80601-2-72-2015 | Medical electrical equipment Part 2-72: Particular requirements for the basic safety and basic performance of ventilators in ventilator-dependent family healthcare environments | |
| EN 14048-2002 | Determination of degradation in the final packaging bio gasification oxidizing medium packaging material closed ventilator oxygen measurement | |
| EN 14529-2005 | Self -contained open-circuit compressed air ventilator with half-mask type mask containing a positive pressure respirator controlled by a demand valve | |
| EN 60601-2-12-2006 | Particular requirements for the safety of medical electrical equipment lung ventilator. Part 2-12: Critical care ventilator |
| Russia | GOST R ISO 80601-2-12-2013 | Medical electrical equipment. Part 2-12. Special requirements for basic safety and basic performance of intensive care ventilators |
| International standard | ISO 10651-6-2004 | Particular requirements for the basic safety and main performance of medical lung ventilators. Part 6: Auxiliary equipment for household ventilators |
| ISO 80601-2-12-2011 | Medical electrical equipment. Part 2-12: Detailed requirements for basic safety and essential performance of emergency care ventilator | |
| ISO 80601-2-72-2015 | Medical electrical equipment. Part 2-72: Particular requirements for the basic safety and basic performance of ventilators in ventilator-dependent home healthcare environments |
Import and ship COVID-19 test kit, medical masks, medical protective clothing, ventilator, infrared thermometer，protective gloves, goggles from China.
One-stop guide&unserstanding, update 2020, All you need to know!（All legal, with all types of supplier resources attached！）