NMPA Quality Spot Check: 12 Batches of Products Are Unqualified!

On April 20, the NMPA issued a notice on the results of the national supervision and sampling inspection of medical devices. The NMPA organized the product quality supervision and sampling inspection of five varieties, such as intervertebral fusion cage and semiconductor laser treatment machine. A total of 12 batches (sets) of products did not meet the standards. The details are as follows:

Medical device products that do not meet the standards:

I . Two batches of interbody fusion cage: produced by Dezhou Joint, involving surface roughness that does not meet the standard.

II.1 set of semiconductor laser treatment machine: produced by Silo (China) Medical Equipment Co., Ltd. , the marks involved does not meet the standard provisions.

III.1 set of carbon dioxide laser treatment machine produced by Wuhan Jin Lai Te Medical, the accuracy and marking of external markings, control devices and instruments involving equipment or equipment parts do not meet the requirements of the standard.

IV. 1 handheld ultrasonic diagnostic equipment: produced by Weihai Weigao Medical Imaging Technology Co., Ltd., the external markings involving equipment or equipment parts do not meet the standard requirements.

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