Inspection check-list for masks imported from China

COVID-19 is sweeping the whole planet, while there are some safe zones left, including China. Industries are recovering and becoming even more robust with lock-down being released when pandemic outbreak continues unchecked in many western countries. This discrepancy may have talked you into importing some medical devices from China to earn profits in the domestic market. As a matter of fact, miscellaneous Chinese factories previously specializing in civil textiles and even machineries cannot wait to introduce medical products into their routine business, and they all seek for exporting medical products to foreign importers like you.

This trend raised a serious and emergent question: As an importer who are nearly clueless about China, how could I avoid fraudulent acts? This is not exaggerated because there are considerable number of buyers being trapped in litigation processes only to get a reimbursement from frauds in disguise of real exporters. We thus recommend you the following strategies.

Qualification check is a prerequisite. The identification of statutory qualification of a Chinese exporter consists of two divisions: domestic administrative approvals and international standards. We are going to look at domestic approvals at first.

Chinese government has set up a regulatory system to address medical device quality problems. Basically, a manufacturer needs to register in the State Drug Administration. With regard to registration, manufacturers are required to report the type of medical products they are manufacturing (such as personal protective face masks, KN95 face masks and surgical gowns) according to a statutory classification method. If officially issued the permission of mass production of respective devices, the database will keep a record of its name and the type of products that it was permitted to manufacture. For convenience, the administration runs a website (http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html?type=ylqx&CbSlDlH0=qAqacAcQvxnQvxnQvlKZt0ukSEp2dlk5nF.xFfVuGl3qqxa ) providing enquiry service. However, only Chinese language service is available, you could contact us if you prefer our assistance.

Through enquiry, you could easily determine whether a certain company is in possession of official permission regarding medical device production, as well as the exact captioned type.

Second, in order to ensure the imported products are acceptable for medical or personal protective use, most importers will request that contracted goods shall be FDA-approved, sometimes shall be affixed with CE marking as well. So many Chinese exporters will provide the picture of their FDA and CE certificates accordingly. But these pictures are not necessarily trust-worthy, a preliminary inspection is indispensable.

With regard to FDA approval, you could click in the official FDA manufacturer database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm), fill in your suppliers’ trading name, and you could find out if the said supplier is within in the FDA’s list. CE certificate is not issued by European official institutes but rather many authorized testing institutions. You will need to search the certificate number on the issuing institution’s website just like you do on the FDA database website. The certificate number and the exact name of issuer are identifiable.

Above is our advice to future importers. However, these cannot necessarily hold you harmless against miscellaneous forms of frauds. Other further legal investigations, such as a credit report will serve you better. Contact us if you need our assistance.

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Larry Zhou, Partner

Landing Law Offices China

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