指外交部认证或使馆认证。 外交部认证是我国外交部领事司或有关省、自治区、市的外事办公室的认证。 使馆认证是办理公证证书的使用国驻华使（领）馆的认证。
双认证指外交部认证和使馆认证。 在办妥我国外交部领事司或有关省、自治区、市的外事办公室的认证手续后，再办理公证证书的使用国驻华使（领）馆的认证。 那么境外公司投资主体资格证明材料公证认证该如何办理？
境外公司投资主体资格公认认证流程海外公司主体资格公证认证，是需要经过三个步骤的，缺一不可，步骤为固定的。 步骤一 境外投资方的境外公司需经当地国公证 步骤二 所在国外交部认证 步骤三 中国驻该国使馆认证 第三步是至关重要的，在国内使用该认证文件时，主要核实文件上中国驻外使馆的章印或签字。 在国内使用前还需按照使用部门要求提供中文译本。 总结： 境外投资方的境外公司需经当地国公证+所在国外交部认证+中国驻大使馆认证。
Coronavirus outbreak in Europe
Coronavirus outbreak in South Korea & Japan
As of 8 April 2020, the total Coronavirus cases in South Korea is 10,423, with 204 death.
Spanish demand grows 100 times
Korean mask prices up 800%
Italian mask prices soar 10,000%
But even though the price is so expensive, masks in some northern supermarkets are almost sold out.
In addition, Amazon, eBay, and other platforms have also appeared on N95 masks priced more than 1,000 US dollars, the price was incredible.
Under such circumstances, many foreign companies turned to China for importing masks.
By the end of February, the daily production capacity of masks in China has reached to 110 million units that came in medical and non-medical calibers, the National Development and Reform Commission said.
However, risks remains with the booming production.
Risks of Importing Masks From China
Recently, in Wenzhou, 70 new mask manufacturing companies were established in 5 days.These companies only have manufacturing capabilities, and not obtained export licenses for medical devices.
What else risks you might be faced with?
At present, the quality of masks produced by Chinese mask suppliers has various grades. Regardless of disposable medical masks or N95 masks, the price of a good quality mask is two or three times that of a poor quality mask.
Many large-scale mask manufacturers are required to pay the full payment before placing an order. This is a huge pressure and risk for the funds of overseas sellers and importers.
Presently, many large and medium-sized mask exporters in China have a minimum order of 300,000 to 500,000. If you purchase nearly 1 million masks, do you have the ability in a short time to sell them out? Worth considering.
Delivery time of the masks is another hidden risk. If a factory gives you a 100% guaranteed delivery time, please be careful cause the raw material and workers in the factories are still in shortage.
What qualifications for exporting masks from China?
Exporting mask from China (Corporate Action) for overseas sales of masks:√ Only those who have a medical device business license in the business scope, and those with import and export rights are allowed to export.
Used as a gift or as a purchase maskAs a gift or for purchasing on behalf of an affiliated company (parent-subsidiary, importer), provide relevant certification documents, business license, product medical device filing certificate, manufacturer inspection report.
The Basic Import Requirements & Standards of Masks in several major countries and regions
1. Bill of landing
2. packing list
4. South Korean importer’s business license
If masks are made in China, they must equipped with required documents shown as follows:
1. “Made in China” labels
2. manufacturer information
3. shelf life
4. ingredient content instructions,
5. manufacturing process.
After the goods arrive in South Korea, the goods will be sent to the laboratory for precise supervision and testing. After passing the testing, Chinese maks can finally enter the Korean market for sale.
1. Bill of landing
2. packing list
4. Registration with PMDA Business information
The package of masks is required to achieve 99% of the following filtration efficeincy standard:
PFE: filtration efficiency of 0.1um particles and particles
BFE: bacteria filtration rate
VFE: virus filtration rate
カ ル ス カ ッ ト: virus blocking
o Medical protective masks: in accordance with China’s GB 19083-2010 mandatory standard, filtration efficiency ≥95% (tested with non-oily particles).
o N95 mask: American NIOSH certification, non-oily particulate matter filtration efficiency ≥95%.
o KN95 masks: Comply with China’s GB 2626 mandatory standard, non-oily particulate matter filtration efficiency ≥95%
In the EU, masks are PPE personal protective equipment. From 2019, the new EU regulation PPE Regulation (EU) 2016/425 will be enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulations.
CE certification is a compulsory product safety certification system implemented by the European Union to protect the lives and property of people in EU countries.
1 Bill of landing
2 packing list
4 FDA certification
According to HHS regulations, NIOSH classifies its certified anti-particulate masks into 9 categories. The specific certification is operated by the NPPTL laboratory under NIOSH.
In the United States, masks can be classified into three grades-N, R, P according to the minimum filtering efficiency of the filter material.
N-type masks can only filter non-oily particles, such as: dust, acid mist, paint mist, microorganisms, etc. Most of the suspended particles in air pollution are non-oily.
R-type masks masks are only suitable for filtering oily particles and non-oily particles, but when used for oily particles, the use time must not exceed 8 hours.
Type P masks can filter both non-oily particles and oily particles. Oily particles such as oil fume, oil mist, etc.
According to the different filtration efficiency, there are differences of 90, 95, 100, which means that the minimum filtration efficiency is 90%, 95%, 99.97% under the test conditions specified in the standard.
N95 is not a specific product name. As long as the product meets the N95 standard and passes the NIOSH review, it can be called an “N95 mask”.
Common Questions Summary
Q: What qualifications are required for enterprises exporting medical materials?
A: In summary, if the product is not certificate-related, it can be exported as long as it has the right to import and export.
If it is a certificate-related product, four qualifications are required:
1 import and export rights
2 Business license
3 Filing certificate or Registration certificate
4 Manufacturer test report
Q: I want to export to Japan and Korea at the same time, do I have to meet the standards of their countries? What are the standards?
A:Yes, it must meet the standards of other countries, otherwise it is impossible to enter.
Exporting to Japan is subject to the requirements of the PMD Act. The TOROKU registration system requires foreign manufacturers to register the manufacturer’s information with PMDA.
When exporting to Korea, the country of origin must be marked, and KF certification is required.
Q: What qualifications and certificates are required for the export of ordinary masks and medical masks?
A: Masks of Class II and Class III medical devices require a filing certificate or registration certificate before they can be exported.
Q: Trading companies do not have medical equipment qualifications, can they export masks? Manufacturers can provide three certificates, is there any problem with tax refund?
A: Yes, it is completely exportable for manufacturers if they have three certificates. Of course, the business scope of foreign trade companies preferably includes labor protection supplies. In this way, export tax rebates are safer.
Q: What certification do I need to apply for if masks are to be exported to Iran?
A: Exporting to Iran is still relatively complicated, and it is necessary to apply for COI certification in Iran, which is the relevant inspection required by Iran for mandatory shipping.
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