Shanghai imported medical devices continued to grow

January 24 hearing with the medical device products to the customization and high value-added direction, the domestic demand for imported medical devices continued to grow.According to the Shanghai Exit Inspection and Quarantine Bureau statistics, in 2017 Shanghai imported medical devices a total of 33,704 Over the same period of the previous year, up by 18.84% and 22.43% respectively over the same period of the previous year. In the meantime, the unqualified detection rate also increased by 10% over 2016, accounting for nearly 30% of all imported medical device products of the year.

According to reports, the continuous growth of imports of medical devices, due to strong national support for the domestic high-end medical equipment industrialization of key technologies, the introduction of advanced technology to improve the domestic medical device production technology and core competitiveness.

However, as a key sensitive commodity, the quality of imported medical devices is directly related to the health care workers and patients health And safety of life, involving various aspects of safety, hygiene and environmental protection. Moreover, the product range is diverse, the channels for sales and use are complex, and the management level of business units is uneven.

Therefore, with the continuous increase of import volume, the inspection and quarantine departments also stepped up the supervision of imported medical devices.In 2017, Shanghai Inspection and Quarantine Bureau highlighted the compliance verification of imported medical devices and found that 8863 batches were rejected and returned And destroyed 106 batches.

The reasons for the unqualified include the failure of the Chinese label instruction, the quality defects, the unqualified safety items, the inconsistency with the medical equipment registration certificate provided by the declaration of entry, the old medical equipment that is prohibited from being imported, the damage occurred during the transportation, etc. Among them, the Chinese Label or instruction manual does not meet the requirements of the situation become the main cause of failure.It is understood that, in order to strengthen the safety supervision of medical devices, Shanghai Inspection and Quarantine last year and the Shanghai Food drug Supervision and Administration signed a memorandum of cooperation, including the promotion of jointly medical instruments Trade facilitation; jointly established product quality Safety risk monitoring mechanism; jointly build product quality and safety information tracking system.