Zhenjiang national inspection for the import of medical equipment | 'pulse'

Imported medical devices will also be 'sick', there are some quality and safety risks from the Jiangsu Inspection and Quarantine Bureau, Jiangsu Zhenjiang last year imported 26 batches of medical devices, There are 5 batches of unqualified inspection, batches of unqualified rate of 19.23%.

It is understood that the import of Zhenjiang in Jiangsu Province medical instruments Mainly from South Korea, Germany and the United States and other countries, the main varieties of X-ray products, including X-ray computed tomography equipment, medical angiography X-ray machines, there is the ultrasound products, including ultrasound, B- Inspection unqualified mainly because the product and the instructions are not marked mercury and lead, cadmium and other harmful substances in the name and content, as well as the product without Chinese labels and Chinese instructions, etc. For these substandard imports of medical equipment, Zhenjiang Inspection and Quarantine Bureau for disposal according to law , According to the requirements of supervision and rectification, fully qualified before they can be put into use.

Medical equipment and people's lives health Closely related to the inspection and Quarantine Bureau of Zhenjiang attaches great importance to inspection and supervision of the import of medical equipment based on the "Regulations on the Supervision and Administration of Medical Devices", "Imported Medical Device Inspection and regulatory requirements" and the relevant mandatory medical equipment standard Of the implementation of the test, the key medical device registration card validity, label identification and specification compliance and other related content to conduct rigorous testing.At the same time, strengthen the collection of information on the quality of medical device products, focusing on the US FDA, the European Union REPAX And other issues of poor medical device information, multi-channel collection of imported medical device products appear quality problems, in time for the import of medical devices enterprise Provide information consultation to ensure the quality and safety of imported medical devices.