Medical devices

In most cases yes. We declare through the affiliated entity that holds the relevant business record-filing, so the customer does not need a licence of its own to receive the goods. The device’s own Chinese registration is a separate question: the certificate is issued to the registrant rather than to us, and an overseas registrant appoints a China-based agent to hold it. Where a device has no registration yet, that is a route we can run rather than a wall — see the next question.

No. It changes what the first shipment is for. Samples for research and testing, clinical trial material and exhibition goods each travel on their own route without a registration certificate. Alongside that we can run the registration route itself: arranging type testing at a qualified institute, coordinating the clinical evaluation or trial where the class calls for one, and supporting the application through to the certificate that opens the market. What cannot be compressed is the timeline — for a device that needs a trial, registration shapes the commercial plan long before freight does.

By the Chinese classification rules, applied to what the device does and where it is used, not by the classification it carries at origin. We check this before anything is booked, because the class decides the licence and the licence decides who can declare.

Those are separate routes with their own documentation. The intended use has to be settled before the goods travel, because it is the stated purpose that determines the route, and changing the stated purpose after arrival is slow.

Products imported for research or testing, and not used for human diagnosis or treatment, do not require registration or record-filing. The condition is that the declaration states the true purpose. Customs checks actual use, and a product declared for research but used clinically can be ordered re-exported or destroyed, so this route is only worth taking when it genuinely describes the shipment.

Components supplied as production inputs to a device manufacturer do not need separate record-filing or registration. Where an existing certificate’s structure-and-composition annex does not limit component models, a component consistent with the recorded information falls inside that certificate.

Usually the inspection follows the declared destination, and for equipment that can only be assessed once installed it happens at the stated place of use. A few high-risk products are restricted to named customs districts regardless of routing — imported pacemakers, for example, are inspected at Beijing or Shanghai, with Haikou handling units approved in Hainan for urgent clinical need. Where such a restriction applies, it is worth designing the routing around it rather than discovering it on arrival.

Before the goods are booked. Licences attach to entities rather than to shipments, and putting the right entity in place takes longer than moving the freight.