Notice of NMPA on The Issuance of the Results of the National Medical Device Supervision and Sampling Test (No. 1) (No. 22 [2022])
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- Time of issue:2022-04-21
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(Summary description)
Notice of NMPA on The Issuance of the Results of the National Medical Device Supervision and Sampling Test (No. 1) (No. 22 [2022])
(Summary description)
- Categories:News
- Author:
- Origin:
- Time of issue:2022-04-21
- Views:0
In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical devices, NMPA organized product quality supervision and sampling inspection of 5 kinds of products, including interbody fusion device and semiconductor laser therapy device. A total of 12 batches (sets) did not meet the standards. The details are as follows:
I. Medical devices that are not in conformity with the standards
(1) 2 batches of interbody fusion device: Produced by Dezhou Jinyuying Medical Instrument Co., LTD., the surface roughness involved did not meet the standard provisions.
(2) 1 semiconductor laser therapy machine: CAO Group,Inc. Silo Group production, involving the mark does not meet the standard provisions.
(3) 1 carbon dioxide laser therapy machine: produced by Wuhan Jinwright Optoelectronics Co., LTD., the accuracy and marking of external marks, control devices and instruments related to equipment or equipment components do not meet the standards.
(4) 1 set of hand-held ultrasonic diagnostic equipment: manufactured by Weihai Weigao Medical Imaging Technology Co., LTD., the external marks of the equipment or equipment parts do not meet the standards.
(5) 7 shadowless lamps: Respectively, changzhou united medical lighting co., LTD., hebei yi ogilvy medical equipment co., LTD., heng zhi Ann medical equipment (Shanghai) co., LTD., shandong MCL kornhill medical instrument co., LTD., shandong xin rain medical equipment group co., LTD., shandong xinhua medical instrument co., LTD., Shanghai JiShun medical equipment manufacturing co., LTD., production, The protection grounding impedance, center illuminance, single shutter illuminance measurement, and total irradiance do not meet the standard.
Please refer to the attachment for the details of the products not in conformity with the standards mentioned above.
II. About the above samples do not conform to the standards, NMPA has asked the local pharmaceutical supervisory and administrative departments at the provincial level enterprise, in accordance with the "regulations on the supervision and administration of medical devices "medical devices supervision and administration of production method" and "measures for the management of medical device recall" requirements, such as timely make a decision on administrative punishment and publish to the society. Provincial pharmaceutical supervisory and administrative departments should urge enterprises to carry out risk assessment on the products that do not meet the standards, determine the recall level according to the severity of the defect of medical devices, take the initiative to recall the products and disclose the recall information; Urge enterprises to find out the cause of product nonconformity as soon as possible, formulate corrective measures and timely rectification in place.
We hereby inform you.
Attachment: list of products that do not meet the standard by sampling inspection
Click here to get more information国家药监局关于发布国家医疗器械监督抽检结果的通告(第1号)(2022年第22号) (nmpa.gov.cn)
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