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The management method will divide the import units of medical devices into three types of importers, one, two and three types. At the same time, the imported medical device products are divided into three risk levels: high risk, high risk and general risk, and according to different importer categories and Different product risk levels, using different inspection and supervision modes. The new management measures also further clarify and stipulate the documentary information required for inspection and inspection, the content of inspection and supervision, the inspection and supervision of imported donated medical devices, risk warning and rapid response measures, and administrative penalties.
At present, China's imported medical device market is expanding rapidly. In recent years, it has imported hundreds of millions of dollars each year, but the quality of its products is mixed. The forthcoming Measures for the Supervision and Administration of Imported Medical Devices will strengthen the inspection and supervision of imported medical devices, and the quality of imported medical devices will be more secure. "Proper sales, use of unregistered or untested statutory imported medical devices; sales, use of imported medical devices that have been inspected, spot-checked or verified to be unqualified; old medical devices that are prohibited from importing by importing countries will be severely punished by law."
Inspection and quarantine reminds medical equipment import list
The "Administrative Measures for the Supervision and Administration of Imported Medical Devices" will be implemented in December.
The "Administrative Measures for the Inspection and Supervision of Imported Medical Devices" implemented on December 1, 2007 will implement the classification management of medical device importing units, the inspection and supervision of imported medical devices, and the implementation of risk warning and rapid response management for imported medical devices. Strengthen the inspection and supervision in three aspects.