The website of the State Food and Drug Administration recently released the "Notice on Publishing the Results of the National Medical Device Supervision and Sampling Inspection" (hereinafter referred to as the "Notice"). The "Notice" shows that it is marked as Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd. (hereinafter referred to as Zhongyuan Fuli), Guangdong Jingjing Medical Technology Co., Ltd., Jiujiang High-Tech Pharmaceutical Technology Co., Ltd., Wulanchabu Qiaoshi Weiye Medical Devices Co., Ltd. 12 batches of medical devices such as magnetic therapy stickers produced by 9 companies including Nanjing Saierjin Biomedical Co., Ltd. did not meet the standards.
According to reports, magnetic therapy stickers mainly use magnetic fields and magnetic lines of force to act on the human body to treat or relieve local ailments; far-infrared stickers are spectral radiation therapy devices that use spectral radiation to act on the human body to achieve treatment or relief. Both of them belong to sticking medical devices. Adhesive medical device products must comply with national mandatory standards and approved product technical requirements, and illegal addition of drugs without approval is not allowed.
The reporter logged into China Health Media Group's food and drug public opinion monitoring system and found that this is the second time that Zhongyuan Fuli has been "named" by the regulatory authorities for substandard products this year. On February 2 this year, the Shanxi Provincial Food and Drug Administration issued the "Notice on the Release of the Results of Medical Device Supervision and Sampling Inspection", which showed that it was marked as a hot compress produced by Zhongyuan Fuli (batch number: 20220302; model specification: 80mm*90mm/paste/bag ) does not meet the standard requirements, and the unqualified item is the temperature characteristic-duration.
For the above-mentioned non-compliant products found in the sampling inspection, the State Food and Drug Administration has requested the provincial drug supervision and management 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 "Recall of Medical Devices" Management Measures" and other requirements, make administrative decisions in a timely manner and announce them to the public. Provincial drug supervision and management departments should urge enterprises to conduct risk assessments on products that do not meet the standards in random inspections, determine the recall level according to the severity of medical device defects, actively recall products and disclose recall information; urge enterprises to find out the reasons for product failure as soon as possible, Formulate corrective measures and implement them on schedule.
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