The State Food and Drug Administration released the results of medical device supervision and sampling inspection of 12 batches (sets) of unqualified products

On April 20, the State Food and Drug Administration issued an announcement stating that in order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical device products, the State Food and Drug Administration organized five varieties of intervertebral fusion cages and semiconductor laser treatment machines.
Product quality supervision and sampling, a total of 12 batches (sets) of products did not meet the standard requirements
.
The specific situation is notified as follows: 1.
Medical device products that do not meet the standard requirements for the sampled items (1) 2 batches of interbody cages: produced by Dezhou Jinyueying Medical Device Co.
, Ltd.
, and the surface roughness does not meet the standard requirements
.
(2) 1 semiconductor laser treatment machine: produced by CAO Group, Inc.
Xierou Group, and the markings involved do not meet the standard requirements
.
(3) 1 set of carbon dioxide laser therapy machine: produced by Wuhan Jinlait Optoelectronics Co.
, Ltd.
, the accuracy and marking of external markings, control devices and instruments involving equipment or equipment parts do not meet the standard requirements
.
(4) 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
.
(5) 7 surgical shadowless lamps: Changzhou Meiya Medical Lighting Co.
, Ltd.
, Hebei Yi'an Ogilvy Medical Equipment Co.
, Ltd.
, Hengzhi Medical Equipment (Shanghai) Co.
, Ltd.
, Shandong Kangyi Medical Equipment Co.
, Ltd.
, Shandong Xinyuchen Medical Equipment Group Co.
, Ltd.
, Shandong Xinhua Medical Equipment Co.
, Ltd.
, and Shanghai Jishun Medical Equipment Manufacturing Co.
, Ltd.
are involved in the production of protective grounding impedance, central illuminance, single-shutter illuminance measurement, and total irradiance
.
2.
For the above-mentioned products that do not meet the standard requirements found in the random inspection, the State Drug Administration has required the provincial drug supervision and administration department where the enterprise is located to comply with the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Medical Device Production" and "Medical Devices".
Recall Management Measures and other requirements, make administrative decisions in a timely manner and announce to the public
.
Provincial drug regulatory authorities should urge enterprises to conduct risk assessments on products that do not meet the standard requirements, determine the recall level according to the severity of medical device defects, voluntarily recall products and disclose recall information; urge enterprises to identify the reasons for product failure as soon as possible, Develop corrective measures and rectify them on time
.
Attachment: List of products that do not meet the standard requirements for random inspection