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.
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
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.
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.
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.
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.
Used medical devices are prohibited from importing into China.
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.
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
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 broker
which would affect the use of the contained medical devices. The
shipment was returned in the end.
before shipping to China, it is very important to pack medical
devices well and sound to keep them from getting da