Recently, affected by the global outbreak, the demand for anti-epidemic materials such as masks has increased greatly in foreign countries, and the export of masks has become the focus of attention.
So, what kind of qualification is needed for mask export? What information is needed? For details, please refer to this article about the exit of mask.
In addition to the above, what else should we pay attention to at the exit of the mask?
Must read for export
First of all, understand the relevant qualifications of medical devices:
L where the manufacturer is engaged in the production of class I medical devices, it shall file with the food and Drug Administration of the people’s Government of the city divided into districts;
L for the production of class II and class III medical devices, the manufacturer shall apply to the food and Drug Administration of the people’s Government of the province, autonomous region and municipality directly under the central government where it is located for the production license;
L no license or record is required for the operation of class I medical devices;
L the second type of medical devices shall be operated under the record management, and the business record certificate of medical devices shall be handled;
L license management shall be carried out for the operation of class III medical devices, and the operation license for medical devices shall be handled.
For details, please refer to regulations on the supervision and administration of medical devices, measures for the supervision and administration of medical device production and measures for the supervision and administration of medical device operation
Medical masks belong to class II medical devices, which shall be within the scope of business, obtain medical device registration certificate / medical device production license / medical device business filing qualification, and have the right to import and export business.
For sale and export, general trade method can be used for declaration. It is recommended to upload the following declaration list.
- When the non-medical masks (not belonging to the scope of medical devices) are export customs declaration, the words “non-medical” shall be indicated:
- Invoice and packing list
- Test report (CMA CNAs) and certificate of conformity (factory inspection sheet)
- Other supplementary documents required by the customs
B When the medical mask is exported for customs declaration, enter “epidemic prevention materials and Certificate No.” in the remark column
- Invoice and packing list
- Medical device business record certificate
- Test report (CMA, CNAs) and certificate of conformity (factory inspection sheet)
- Other supplementary documents required by the customs
Important reminder
(Medical masks and other medical devices)
- If the manufacturer exports medical devices, it shall first handle the product export record and export sales certificate (see the end of the article for the website), and shall establish and keep the export product file. The contents include the export sales certificate of medical device products and the export record form of medical device, purchase contract, quality requirements, inspection report, qualification certificate, packaging, label style, customs declaration, etc., which have been handled to ensure the traceability of the export process of products.
- For the production of exported medical devices, it is necessary to ensure that the medical devices it produces meet the requirements of the importing country (region), and to file the product information with the local food and drug administration at the municipal level.
- If the manufacturing enterprise accepts the entrustment of the overseas enterprise to produce the medical devices listed and sold abroad, it shall obtain the third-party certification of the medical device quality management system or the domestic production license or record of similar products.
- No matter what kind of trade mode, unqualified three no products cannot be exported normally.
- The declaration indicates that it is epidemic prevention materials. When exporting, customs clearance shall be carried out according to inspection instructions. Quality inspection report (or spot sampling for inspection) shall be provided according to the requirements of Customs on-site inspection, and three complete certificates (medical device registration certificate, medical device production license and medical device operation license) can be provided.
Related website:
National standards and certification requirements for the export of masks
The following are the supplementary standards and certification requirements for respirators in major regions and countries. For other requirements, please refer to: for the export of respirators, this article is enough
Personal mail
- Due to the different requirements of each country for imported masks, it is recommended that you consult your local agent or receiver before exporting to avoid the materials being withheld or returned;
- For the export and express delivery of self-use masks, the quantity must be within a reasonable range. If the quantity is huge, it may also be seized by foreign customs;
- At present, the air and sea transportation capacity has not been fully restored, and the transportation time is relatively long. It is recommended to pay attention to the update of the bill number after delivery, and wait patiently. As long as there is no violation, it will not be detained or returned.
China Export (corporate behavior)
For sale
Only those with medical device business license and import and export right within the business scope can be exported.
Used for gift or purchasing on behalf of others
As a gift, or purchasing on behalf of related companies (brother companies, parent and subsidiary companies), we need to provide relevant qualification certificates of purchasing manufacturers or domestic manufacturers of the company, and we need to provide three certificates (business license, product medical device Filing Certificate, factory inspection report) when we import.
The Republic of Korea
Respirator standards and certification requirements
KF (Korean filter) series of mask standards in South Korea is the mainstream mask standards in South Korea (regulations on the approval, notification, and evaluation of quasi drugs) issued by the Ministry of food and drug safety (MFDs) in South Korea.
Japan
Respirator standards and certification requirements
Jist81512018 standard of Japan is the standard of respiratory protection device and the verification standard of MHLW, which is required for export to Japan.
European Union
Respirator standards and certification requirements
Certification requirements for general respirators:
The European standards for personal protective masks are en149 and en143. The protective masks need to meet the requirements of the European Union Personal Protective Equipment Directive (PPE), review the quality management system and CE technical documents of the enterprise, and obtain CE certificate of PPE regulations after passing the review.
Certification requirements for medical protective masks:
U.S.A
Respirator standards and certification requirements
Certification requirements for general respirators in the United States:
According to FDA class I medical certification, the process is as follows:
① Fill in the application form and confirm the information;
② Obtain pin code and pay annual fee;
③ Issue registration number;
④ Export of products.
Medical surgical mask certification requirements:
According to FDA class II medical certification, the process is as follows:
① Product test (performance test, biological test);
② Prepare 510k documents and submit them to FDA for review;
③ FDA sends 510k approval letter;
④ Complete factory registration and machine listing;
⑤ Export of products.
9 kinds of mask certification requirements for medical N95 and above:
According to NIOSH certification standards, enterprises need to send samples to NIOSH Laboratory for testing, and submit technical data to NIOSH document review. After the document review and test are passed, NIOSH will issue the approval document.
Australia & New Zealand
Respirator standards and certification requirements
AS/NZS 1716:2012 is the standard for respiratory protective devices in Australia and New Zealand, and the manufacturing process and testing of relevant products must comply with this specification.
Note: the above content is for reference only, please refer to the actual business!
Policies of e-commerce platforms on anti-epidemic materials such as masks
At present, novel coronavirus pneumonia grow with each passing day in the global trend is not optimistic, people’s concerns are also increasing. Illegal elements, by virtue of people’s panic, bid up prices, make false propaganda and sell fake goods. In this regard, the major e-commerce platforms have launched corresponding restraint policies. Amazon, eBay and Facebook have all banned the price hike of anti-epidemic materials and strictly controlled the price hike of anti-epidemic materials.
Amazon’s crackdown on price bid
Amazon announced that the global public health crisis was caused by covid-19 coronavirus in the near future. With the increasing demand of buyers for important safety protection goods, Amazon found that some third-party sellers in the mall had excessively inflated their prices. As a result, Amazon will suspend its sales account and remove all of its products for sellers who raise prices excessively and violate the fair pricing policy of Amazon mall.
Amazon has blocked 2500 seller accounts in the US station and deleted 530000 “high price” products based on coronavirus! Amazon is deploying a “professional team” to monitor price fraud of products such as masks and hand sanitizers for 7 days × 24 hours.
EBay banned epidemic related products
Due to regulatory restrictions in the United States and Canada, eBay recently announced that it would ban the sale of masks, hand sanitizers and other new crown related products. From now on, mask products, hand sanitizers or hand washing gels and disinfectant wipes, including N95/N100 and medical surgical masks, are banned from sale. EBay will prevent the new products from being published, and the existing products will also be disposed of.
Mask advertising banned on Facebook
Recently, Facebook has observed a large number of illegal mask advertisements. In order to prevent users from being cheated during the virus, Facebook has banned the use of mask products until further notice. Facebook said it would also stop advertising other products, such as hand sanitizer, and delete Facebook groups and pages linked to the coronavirus.
For cross-border e-commerce sellers, selling masks is a double-edged sword, with high profits but high risks. Qualification certification, source of goods, platform audit, mask quality, export customs clearance and other issues of various countries need to be considered by the sellers. If they are not prepared, they just want to make fast money, and they may lose their lives in the end.
