Published on July 2, 2024
To enhance the supervision and ensure the quality and safety of medical device products, the National Medical Products Administration (NMPA) conducted quality supervision and sampling inspections on three types of medical devices: semiconductor laser therapy machines, medical pulse oximeters, and orthodontic wires. The results revealed that seven batches of products did not meet the required standards.
Summary of Non-Compliant Medical Devices:
Semiconductor Laser Therapy Machines (3 units):
Manufacturers: Changchun Zhongji Optoelectronic Equipment Co., Ltd., Guangxi Hope Medical Devices Technology Co., Ltd., Shanxi Yanzhi Youwu Technology Co., Ltd.
Issues: Input power, accuracy of control devices and instruments, markings, indicator lights and buttons, enclosure tightness, continuous leakage current and patient auxiliary current, laser terminal output power.
Medical Pulse Oximeters (3 units):
Manufacturers: Guangxi Kaier Medical Technology Co., Ltd., Hunan Wanmai Medical Technology Co., Ltd., Shenzhen Kangping Technology Medical Co., Ltd.
Issues: Data updating cycle, signal integrity.
Orthodontic Wires (1 batch):
Manufacturer: Zhejiang Xinya Medical Technology Co., Ltd.
Issues: Dimensions.
Regulatory Actions:
The NMPA has directed provincial drug regulatory departments overseeing the respective manufacturers to take administrative actions in accordance with the “Medical Devices Supervision and Administration Regulation”, “Medical Device Production Supervision and Administration Measures”, and “Medical Device Recall Management Measures”. The enterprises must conduct risk assessments, determine the severity of defects, and initiate product recalls as necessary. They are also required to publicly disclose recall information, investigate the causes of non-compliance, and implement corrective measures within the stipulated timeframe to ensure compliance.
MEDTECH NEWS
NMPA Issues Notice on National Medical Device Supervision and Sampling Inspection Results: 7 Batches Found Non-Compliant (2024 No. 24)
02 07 2024The National Medical Products Administration (NMPA) has released the results of its national supervision and sampling inspection of medical devices, revealing that seven batches of products, including semiconductor laser therapy machines, medical pulse oximeters, and orthodontic wires, failed to meet required standards. The non-compliant items were found to have issues with input power, data integrity, and physical dimensions among others. The NMPA has mandated provincial regulatory authorities to enforce corrective measures, conduct risk assessments, and ensure public disclosure of product recalls.