Cases and Lessons that You shall read Before shipping Medical Devices to China
We share here some cases in which imported medical devices were hold, returned or destroyed by China customs. We will sort out why they had such fate so importers & exporters can have a better idea of what they shall get prepared before shipping medical devices to China and what they shall not do.
Case 1
China customs found in succession imported intraoral scanners, X-ray tube modules, disposable sterilized syringes and Root canal preparation machines that had no registration certificates. These medical devices were ruled as unqualified and were returned by customs.
Lesson:
In accordance with Supervision and Management Regulations for Medical Devices, imported medical devices shall be registered or record filed. Customs shall implement inspections on imported medical devices. Those found unqualified during inspection are banned from import.
Case 2
When inspected a shipment of imported dental units, China customs spotted that the actual model was not consistent with the model as shown on the registration certificate provided by the importer. During inspection on an import shipment containing titanium cage installment toolkits and interbody fusion cage systems, China customs found that these medial devices did not have instruction book or label. It was not possible to identify the country of origin and manufacturer info.It was shown that, By searching the declared registration numbers on the official website of National Medical Products Administration, the registered country of origin was Portugal, which the declared country of origin was China. The shipment was concluded unqualified and was returned.
Lesson:
Imported medical devices shall hold registration certificate, and the actual details(name, brand, model, manufacturer, etc.) shall be consistent with the details as shown on the certificate. Imported medical devices shall come with instruction and label.
Case 3
Three problems were found by China customs when they carried inspection on an import shipment of eustachian tube press instrument. Firstly, the Chinese labels did not conform with relevant regulations as stipulated in Supervision and Management Regulations for Medical Devices. Secondly, the power plugs were not Chinese type. Thirdly, the instruments were made in 2015 and had obvious traces of being used before which meant it was used mechanical and electrical product that was banned from import. This shipment ended up being returned.
Lesson:
Used medical devices are prohibited from importing into China.
Case 4
When inspected a batch of imported oral X-ray digital tomography equipment, China customs found that the Chinese label had missing Chinese elements, and the equipment contained computer hose, keyboard and power lines (hereinafter referred to computer equipment). The above mentioned computer equipment was not shown on the registration certificate. They were not dedicated devices for the said medical device and held no CCC certificate. What was more, their power plugs did not meet Chinese National standards. The computer devices were ordered to return, and the Chinese label was urged to modify.
Lesson
Imported medical devices shall come with instruction book and Chinese label which shall conform to relevant stipulations of Supervision and Management Regulations for Medical Devices. Imported medical devices shall not carry items that are not their self-contained.
Case 5
When inspected a shipment of imported guiding catheter and separable elastic ring system, customs found them top and inside of some cartons got damp and some packages were squeezed and broken which would affect the use of the contained medical devices. The shipment was returned in the end.
Lesson
before shipping to China, it is very important to pack medical devices well and sound to keep them from getting damp or broken.
Related Reading:
