[Global Logistics Solutions Expert ]~ Australian Outbreak Material Presentation (I)

In recent days, the export of epidemic materials has become more and more popular. However, due to the different regulatory conditions for the export of epidemic materials such as masks, the export of masks and other materials now appears cumbersome. Xiaowan summarized the ten most asked questions from our consultation group for customs clearance of the outbreak materials, hoping to answer most of your questions.

Q1: current domestic masks and other epidemic materials can be exported? (There is currently no ban on the export of epidemic materials such as masks by domestic customs)


A1: general masks and other non-medical equipment management of epidemic materials, without regulatory conditions, enterprises with import and export rights, can directly export. The mask and other epidemic materials involved in the certificate need three certificates of products (1) the scope of business license has (including medical device business license ,2) record certificate or registration certificate ,3. factory inspection report), and then enterprises with import and export management right, re-export.


Q2: enterprises that export epidemic materials need to have what qualification?


A2: concluded, the product does not involve a certificate, as long as the right to import and export, can be exported. In the case of licensed products, four qualifications are required: import and export rights, three certificates of products (1) the scope of business license (including medical device operating certificate ,2) record certificate or registration certificate ,3. factory inspection report), the above is the qualification requirements for sales.

If the enterprise wants to give away or replace the overseas affiliated to purchase, need information, the products involved in the certificate need to provide three certificates (ibid.) can be exported.


Do Q3: have to meet their national standards to export to both the US, Japan, South Korea and the EU and Australia? What are the criteria respectively?

A3: yes, we must meet the standards of other countries, otherwise we can not get in.

To export to Japan, TOROKU registration system requires foreign manufacturers to register manufacturer information with PMDA under the requirements of the PMD Act.

Export Korea need to mark origin and need to have KF certification.

for export to the united states masks, must have FDA certification.

masks exported to europe must have CE certification.

Mask requirements for export to Australia and New Zealand:

AS/NZS 1716-2012 are Australian and New Zealand standards for respiratory protection devices, the relevant product manufacturing processes and tests must comply with this specification. The standard specifies the procedures and materials that must be used during the manufacture of the particulate mask, as well as the determined test and performance results to ensure its safe use.


Q4: now our company want to export a batch of license mask, but there is no export qualification, would like to ask can still export?

A4: if it is the products of the factory with three certificates, it can be exported and sold through foreign trade agent. If there are no three certificates, it can not be exported.


Q5: general mask and medical mask export need what qualification, need to handle what certificate?

A5: common and medical, refers to use. And the management of the Bureau of Drug Administration is in accordance with product quality and standards to manage. Mask of medical device of two and three kinds, need record card or registration certificate, can export. the three certificates involved, see the answer to question 2.

Q6: trading company does not have the qualification of medical device, can export mask? Manufacturers can provide three certificates, tax rebate has a problem?

A6: can, the manufacturer provides three certificates is completely exportable. Of course, the business scope of foreign trade companies had better include labor protection supplies and other content. In this way, export tax rebates, are safer.


Q7: we produce melt spray cloth, would like to ask the export of melt spray cloth need medical device certificate?

A7: melt spray cloth does not belong to medical devices and therefore does not require medical device certification.

For medical devices, please visit the official website of the State Food and Drug Administration



Q8: consulted the customs on the supervision of the export of masks, the other side replied that the export of masks customs do not supervise, please consult the Food and Drug Administration request. What do you mean, please?

A8: the customs had no regulatory conditions, all the customs teachers said they would not. But again, the FDA has a request, then the FDA's request is that the products involved in the certificate must have a certificate. As a result, it can be understood that compliance export, certification, need to follow the requirements of the Food and Drug Administration certificate, but the export is not prohibited!


Q9: a lot of small partner ask about individual send mask wait for medical material OK?

A9: is ok. Given the current spread of the epidemic, our small million logistics experts suggest: under the normal volume of less, we can transport according to personal goods, in accordance with the scope of personal use; the value of the proposed value to Australia is around 500~600 Australian dollars.


Q10: if beyond the scope of self-use, there is a general nature of trade, you need to know these below?

TGA registration for A10: exports to Australia is a Therapeutic Goods Administration shorthand known as the Treatment Commodities Authority, which oversees Australian treatment commodities including medicines, medical devices, genetic technology and blood products.

the classification of medical devices in australia is classified into I categories, ls and Im,lla,IIb,III categories. the classification of products is almost consistent with the eu classification. if your products have obtained CE marks, the product category can be classified according to the CE.

the CE certificate issued by the eu bulletin board (Notified Body) can be TGA recognized and can be used as an important registration information to meet australian safety regulations.

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