Kort geleden, getroffen door de wereldwijde uitbraak, the demand for anti-epidemic materials such as masks has increased greatly in foreign countries, en de export van maskers is de aandacht geworden.
Zo, what kind of qualification is needed for mask export? Welke informatie is nodig? Voor details, please refer to this article about the exit of mask.
In aanvulling op het bovenstaande, what else should we pay attention to at the exit of the mask?
Moet lezen voor export
Allereerst, 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.
Voor 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, die binnen de reikwijdte van het bedrijf valt, obtain medical device registration certificate / licentie voor de productie van medische hulpmiddelen / medical device business filing qualification, and have the right to import and export business.
Te koop en te exporteren, general trade method can be used for declaration. It is recommended to upload the following declaration list.
EEN. Wanneer de niet-medische maskers (not belonging to the scope of medical devices) zijn uitvoer douaneaangifte, the words “niet medisch” worden aangegeven:
1. Factuur en paklijst
2. Test rapport (CMA CNA's) and certificate of conformity (blad met fabrieksinspectie)
3. Other supplementary documents required by the customs
B When the medical mask is exported for customs declaration, invoeren “epidemic prevention materials and Certificate No.” in de opmerkingenkolom
1. Factuur en paklijst
2. Medical device business record certificate
3. Test rapport (CMA, CNA's) and certificate of conformity (blad met fabrieksinspectie)
4. Other supplementary documents required by the customs
Belangrijke herinnering
(Medische maskers en andere medische apparaten)
1. If the manufacturer exports medical devices, it shall first handle the product export record and export sales certificate (zie het einde van het artikel voor de 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, koopcontract, Kwaliteitseisen, inspectie rapport, kwalificatie certificaat, verpakking, labelstijl, douaneaangifte, enz., which have been handled to ensure the traceability of the export process of products.
2. 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 (regio), and to file the product information with the local food and drug administration at the municipal level.
3. 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.
4. Het maakt niet uit wat voor soort handelswijze, niet-gekwalificeerd drie geen producten kunnen niet normaal worden geëxporteerd.
5. The declaration indicates that it is epidemic prevention materials. Bij het exporteren, customs clearance shall be carried out according to inspection instructions. Kwaliteitsinspectierapport (or spot sampling for inspection) shall be provided according to the requirements of Customs on-site inspection, en drie volledige certificaten (medical device registration certificate, medical device production license and medical device operation license) kan worden geleverd.
Gerelateerde 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. Voor andere vereisten, zie: for the export of respirators, dit artikel is voldoende
Persoonlijke mail
1. 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;
2. For the export and express delivery of self-use masks, de hoeveelheid moet binnen een redelijk bereik liggen. Als de hoeveelheid enorm is, het kan ook in beslag worden genomen door buitenlandse douane;
3. Momenteel, 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, en wacht geduldig. As long as there is no violation, het wordt niet vastgehouden of teruggestuurd.
China Export (bedrijfsgedrag)
Te koop
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
Als cadeau, or purchasing on behalf of related companies (broer bedrijven, moeder- en dochterondernemingen), we need to provide relevant qualification certificates of purchasing manufacturers or domestic manufacturers of the company, and we need to provide three certificates (zakelijke licentie, product medisch apparaat aanvraagcertificaat, fabrieksinspectierapport) wanneer we importeren.
De Republiek Korea
Respirator standards and certification requirements
KF (Koreaans filter) series of mask standards in South Korea is the mainstream mask standards in South Korea (regulations on the approval, kennisgeving, en evaluatie van quasi-medicijnen) issued by the Ministry of food and drug safety (MFD's) in Zuid-Korea.
Japan
Respirator standards and certification requirements
Jist81512018 standard of Japan is the standard of respiratory protection device and the verification standard of MHLW, die nodig is voor export naar Japan.
Europeese Unie
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 (PBM), 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:
VS
Respirator standards and certification requirements
Certification requirements for general respirators in the United States:
According to FDA class I medical certification, het proces is als volgt:
① Vul het aanvraagformulier in en bevestig de informatie;
② Pincode verkrijgen en jaarlijkse vergoeding betalen;
③ Uitgifte registratienummer;
④ Export van producten.
Certificeringsvereisten voor medische chirurgische maskers:
According to FDA class II medical certification, het proces is als volgt:
① Producttest (prestatie test, biologische test);
② Bereid 510k-documenten voor en dien ze ter beoordeling in bij de FDA;
③ FDA stuurt 510k-goedkeuringsbrief;
④ Volledige fabrieksregistratie en machinelijst;
⑤ Export van producten.
9 kinds of mask certification requirements for medical N95 and above:
Volgens NIOSH-certificeringsnormen, bedrijven moeten monsters naar het NIOSH-laboratorium sturen om te testen, and submit technical data to NIOSH document review. After the document review and test are passed, NIOSH zal het goedkeuringsdocument afgeven.
Australië & Nieuw-Zeeland
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.
Notitie: the above content is for reference only, verwijzen wij u naar de werkelijke zaken!
Policies of e-commerce platforms on anti-epidemic materials such as masks
Momenteel, novel coronavirus pneumonia grow with each passing day in the global trend is not optimistic, people’s concerns are also increasing. Illegale elementen, vanwege de paniek van mensen, bied prijzen op, valse propaganda maken en nepartikelen verkopen. In dit verband, 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.
Het harde optreden van Amazon tegen het prijsbod
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. Als gevolg, 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 heeft geblokkeerd 2500 seller accounts in the US station and deleted 530000 “hoge prijs” products based on coronavirus! Amazon zet een “professioneel team” to monitor price fraud of products such as masks and hand sanitizers for 7 dagen × 24 uren.
EBay verbood epidemiegerelateerde producten
Due to regulatory restrictions in the United States and Canada, eBay recently announced that it would ban the sale of masks, handdesinfecterende middelen en andere nieuwe kroongerelateerde producten. Vanaf nu, maskeer producten, handdesinfecterende middelen of handwasgels en desinfectiedoekjes, including N95/N100 and medical surgical masks, zijn uitgesloten van verkoop. EBay will prevent the new products from being published, and the existing products will also be disposed of.
Maskerreclame verboden op Facebook
Kort geleden, 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 zei dat het ook zou stoppen met adverteren voor andere producten, zoals handdesinfecterend middel, and delete Facebook groups and pages linked to the coronavirus.
Voor grensoverschrijdende e-commerce verkopers, maskers verkopen is een tweesnijdend zwaard, met hoge winsten maar hoge risico's. Kwalificatiecertificering, bron van goederen, platform audit, masker kwaliteit, export customs clearance and other issues of various countries need to be considered by the sellers. Als ze niet zijn voorbereid, they just want to make fast money, en ze kunnen uiteindelijk hun leven verliezen.
