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Import agent customs declaration company shares cases of imported medical devices that are unqualified

Import agent customs declaration company shares cases of imported medical devices that are unqualified

Case 1: An enterprise declared to import a batch of dental files. After on-site inspection by Tianjin Customs officers, it was found that there were no corresponding specifications and models on the labels of the imported dental files, the Chinese label information was incomplete, there was no Chinese manual, and there was no Registration Certificate of Imported Medical Devices in the customs declaration materials, and the enterprise could not provide it. In accordance with the relevant provisions of the Law of the People's Republic of China on Import and Export Commodity Inspection, the Regulations for the Implementation of the Law of the People's Republic of China on Import and Export Commodity Inspection, and the Regulations on the Supervision and Administration of Medical Devices, this batch of goods will be destroyed.

Case 2: An enterprise declared to import a batch of ophthalmic appliances. Tianjin Customs officers found that one of the goods in this batch was a translucent visor, the consignee could not provide the medical device registration certificate, and the goods did not have Chinese medical device labels and instructions. In accordance with the relevant provisions of the Law of the People's Republic of China on Import and Export Commodity Inspection, the Regulations for the Implementation of the Law of the People's Republic of China on Import and Export Commodity Inspection, and the Regulations on the Supervision and Administration of Medical Devices, this batch of goods will be returned.

According to the definition of "medical devices" in the Regulations on the Supervision and Administration of Medical Devices and the Classification Catalog of Medical Devices, "dental files" and "translucent blinders" in the above two cases belong to "medical devices". The imported dental file of the enterprise cannot provide the Registration Certificate of Imported Medical Devices, and the imported "translucent visor" cannot provide the registration and filing certificate of medical devices, and the products do not have Chinese instructions, and the Chinese label information is missing or incomplete, which does not comply with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices.


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