More than 200 billion medical devices to enter China | nearly 30% failed

January 19 Shanghai SAIECIQ disclosed on January 19 that in 2017, a total of 33,704 new medical devices were imported into Shanghai, amounting to US $ 4,305.8 million, up 18.84% and 22.43% over the same period of last year respectively. The unqualified detection rate An increase of 10% over 2016.

In 2017, Shanghai Inspection and Quarantine Bureau stepped up its imports medical instruments Inspection and supervision, with emphasis on the verification of the compliance of imported medical devices, found that 8863 batches were rejected, 106 batches were returned and destroyed. The reasons for the unqualified included unqualified Chinese label instructions, quality defects, unqualified safety items, Medical device registration card does not match, are prohibited imports of old medical equipment, damage occurred in transit and so on.

The import of medical devices Chinese label or instruction manual does not meet the requirements of the main reasons for the failure. Chinese imports of medical device labels, the content contains the product registration information and products standard , Is a product manufacturer's commitment to product safety in the Chinese market.

State Council Order No. 680 has the explicit and mandatory requirements on the Chinese labels and instructions for the import of medical device products. Shanghai Inspection and Quarantine Bureau has strengthened the laws on the operation of product operation units and manufacturers Regulations Publicizing, in order to reduce the occurrence of similar unqualified situation.