National Medical Products Administration's roll call notification! These magnetic therapy patches are unqualified. Ulanqab Qiaoshi Weiye Medical Equipment Co., Ltd. | Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd. | National Medical Products Administration

The website of the National Medical Products Administration recently released a notice on the release of national medical device supervision and sampling results. The notice shows that 12 batches of medical devices, including magnetic therapy patches produced by 9 enterprises including Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd., Guangdong Fine Medical Technology Co., Ltd., Jiujiang High tech Pharmaceutical Technology Co., Ltd., Ulanqab Qiaoshi Weiye Medical Equipment Co., Ltd., and Nanjing Saierjin Biomedical Co., Ltd., do not meet the standard requirements.

It is reported that magnetic therapy patches mainly use magnetic fields and magnetic field lines to exert effects on the human body in order to treat or alleviate local pain; Far infrared patches are spectral radiation therapy devices that use spectral radiation to have an effect on the human body in order to achieve treatment or alleviate pain. Both belong to the category of patch medical devices. Medical device products for application must comply with national mandatory standards and approved product technical requirements, and drugs must not be added illegally without approval.

The National Medical Products Administration has requested the provincial-level drug supervision and management department where the enterprise is located to make administrative decisions in a timely manner in accordance with the requirements of the Regulations on the Supervision and Management of Medical Devices, the Measures for the Supervision and Management of Medical Device Production, and the Measures for the Management of Medical Device Recalls for the above-mentioned products that do not meet the standards and regulations found in the random inspection. The provincial-level drug supervision and management department shall supervise enterprises to conduct risk assessments on products that do not meet the standard requirements during sampling, determine the recall level based on the severity of medical device defects, proactively recall products, and publicly disclose recall information; Urge enterprises to quickly identify the causes of product nonconformities, develop corrective measures, and ensure timely implementation of corrective measures.

Notice of the National Medical Device Supervision and Sampling Results Issued by the National Medical Device Administration

In order to strengthen the supervision and management of medical devices and ensure the quality, safety, and effectiveness of medical device products, the National Medical Products Administration organized product quality supervision and sampling for five varieties, including dental low-voltage electric motors and adhesive medical devices. A total of 12 batches of products did not meet the standard requirements. The specific situation is announced as follows:

1、 Medical device products whose sampled items do not meet the standard requirements

1 dental low-voltage electric motor: produced by Guangdong Meimei Medical Technology Co., Ltd., which involves leakage current, patient auxiliary current, and non compliant no-load speed.

One vertical pressure steam sterilizer: produced by Hefei Huatai Medical Equipment Co., Ltd., which involves the allowable limit values of accessible components under normal conditions and the limit values under single fault conditions that do not comply with standard regulations.

One electric suction device: produced by Suzhou Beiyin Technology Co., Ltd., which is a movable high negative pressure/high flow device driven by grid power and does not meet the standard requirements.

Six batches of adhesive medical devices were produced by Jiujiang High tech Pharmaceutical Technology Co., Ltd., Zhengzhou Zhongyuan Fuli Industry and Trade Co., Ltd., Ulanqab Qiaoshi Weiye Medical Equipment Co., Ltd., Hunan Dexi Medical Technology Co., Ltd., and Chongqing Zhengren Medical Equipment Co., Ltd., involving the detection of "relevant drug components that cannot be detected according to the supplementary testing method requirements.".

Batch 3 of plastic bags for human blood and blood components: produced by Nanjing Selkin Biomedical Co., Ltd., involving blood bag transfusion sockets that do not comply with standard regulations.

The specific situation of the products that do not meet the standard requirements during the above sampling is shown in the attachment.

2、 The National Medical Products Administration has requested the provincial-level drug regulatory department where the enterprise is located to make administrative decisions in a timely manner in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Regulations on the Management of Medical Device Recalls for the above-mentioned products that do not meet the standards and regulations found in the random inspection. The provincial-level drug supervision and management department shall supervise enterprises to conduct risk assessments on products that do not meet the standard requirements during sampling, determine the recall level based on the severity of medical device defects, proactively recall products, and publicly disclose recall information; Urge enterprises to quickly identify the causes of product nonconformities, develop corrective measures, and ensure timely implementation of corrective measures.

This notice is hereby issued.