Importing medical devices during COVID

Prestations au service des échanges internationaux

Importing medical devices during COVID

In these complicated times, not every opportunity should be taken.

Indeed, entrepreneurs find themselves with little or no activity, and therefore turn to business opportunities.  And what are these opportunities at the moment?  Medical devices... And mainly masks.  Who hasn’t received an e-mail from a supplier, a Chinese contact suggesting you buy masks... And irrespective of this contact’s business... Even Chinese freight forwarders are becoming mask suppliers.

In this context, and to limit defects, Chinese customs are strengthening checks on exit from China and are demanding the following documents for any customs export declaration relating to medical devices:

Documents and exchange procedures

 Manufacturer’s commercial licence

  • Licence authorising medical device production
  • Compliance report for manufacturer’s tests (test report with compliance certificate)
  • Medical device registration certificate
  • FDA, EC standard mandatory.
  • Medical label on each product,
  • Requirement to state the subcontractor’s name

If the exporter is unable to present all these documents, the Chinese authorities will not accept the goods for shipment.  In addition, since mask suppliers are generally not the manufacturers, they require full payment with the order so they can pay the manufacturers for the devices.  As a result, if you don’t first ensure that your supplier has all the information required by Chinese customs, you have paid for an order that you will not be able to receive.  And this kind of setback is quite unwelcome for our current cash flow.

Customs aspects

As far as the French customs are concerned, specifically for medical devices, they offer an analysis of the documents prior to the goods arriving, to determine whether or not importing the products will be approved.  Setting up this procedure anticipates hold-ups on arrival but also streamlines flows.

Applications can be sent to the following e-mail address:

On receipt of each application and after examining the documents:

  • Your application is considered compliant => You will obtain Customers Release Notification more quickly
  • Your application is not considered compliant because it is considered incomplete or contains inapplicable documents => the unit will tell you to review your application because, as it stands, it will not be able to obtain a Customers Release Notification and will therefore be held up.

Finally, it is important to differentiate between the requirements of Chinese customs and French customs.  And above all, ANTICIPATE the import and don’t “rush” into the first opportunity for reasons of survival, as it could well prove to be ... fatal!

<h4>Do you need advice on your international exchanges?</h4>
<p>Adeline Grégis
Mobile: +33 (0)6 87 94 03 67
Tel: +33 (0)1 74 92 52 98
Or use the contact form</p>

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