China NMPA Releases National Medical Device Supervision and Sampling Inspection Results (Notice No. 35 of 2026)

On October 10, 2026, the National Medical Products Administration of China issued the Notice on National Medical Device Supervision and Sampling Inspection Results (No. 35 of 2026). To strengthen medical device supervision and ensure product quality and safety, the NMPA organized quality supervision and sampling inspection across 13 categories, including low- and medium-frequency therapy equipment and polyurethane foam dressings. The results show that 27 batches/units failed to meet standards. Full model, batch/serial numbers and testing institutions are in the official annex.

For low- and medium-frequency therapy equipment, 4 units failed, involving Foshan Nanhai Dongtianyang Industrial Co., Ltd., Guangdong Yangcheng Electronics Co., Ltd., Guangzhou Fengdeli Medical Devices Co., Ltd., and Tianjin Sidianling Intelligent Technology Co., Ltd. Noncompliance items included leakage current and patient auxiliary current (at operating temperature), output lockout, output, and voltage and/or energy limitation.

For joint training equipment, 1 unit failed, involving Henan Bote Medical Devices Co., Ltd. The noncompliance item was continuous leakage current and patient auxiliary current (at operating temperature).

For red light therapy equipment, 1 unit failed, involving Jindawei Medical Technology (Hunan) Co., Ltd. The noncompliance item was leakage current and patient auxiliary current (at operating temperature).

For surgical electrodes (high-frequency bipolar), 2 units failed, involving Sainuowei Medical Technology (Zhejiang) Co., Ltd. and Zhenjiang Hengsheng Juanen Medical Devices Co., Ltd. The noncompliance item was usability of ME equipment.

For sleep apnea therapy equipment, 1 unit failed, involving Jiangsu Kangshang Biotechnology Co., Ltd. The noncompliance item was requirements for increased audible sound energy.

For microwave therapy equipment, 2 units failed, involving Nanjing Huabei Electronic Medical Equipment Co., Ltd. and Shenzhen Xinghui Technology Co., Ltd. Noncompliance items included input power and stimulation output.

For polyurethane foam dressings, 2 batches failed, involving Ferris Mfg. Corp and Henan Tuoren Best Medical Devices Co., Ltd. Noncompliance items included liquid absorption and liquid penetration.

For nephrostomy kits, 2 batches failed, involving Hunan Weidekang Medical Technology Co., Ltd. and Zhejiang Yigao Medical Technology Co., Ltd. The noncompliance item was the guidewire rupture test.

For ureteral interventional guidewires, 1 batch failed, involving Zhangjiagang Oukai Medical Devices Co., Ltd. The noncompliance item was peak tensile strength.

For medical protective masks, 1 batch failed, involving Jilin Franc Medical Technology Co., Ltd. The noncompliance item was filtration efficiency.

For medical sodium hyaluronate dressings, 8 batches failed, involving Guangxi Yimei Pharmaceutical Technology Co., Ltd., Hunan Li'erkang Medical Technology Co., Ltd., Hunan Rui Laier Medical Devices Co., Ltd., Hunan Tengqi Medical Technology Co., Ltd., Hunan Xingma Nanyang Biomedicine Co., Ltd., Hunan Zhimei Biomedicine Co., Ltd., Hunan Zhongxi Medical Technology Co., Ltd., and Jiangsu Jia'ao Medical Technology Co., Ltd. Noncompliance items included sterility and microbial limits.

For sports injury soft tissue repair and reconstruction implants (suture anchors, knotless anchors, fixation pins, fixation plates, repair sutures, and meniscal repair suture consumables), 1 batch failed, involving Shanghai Sanyou Medical Devices Co., Ltd. Noncompliance items included fixation plate material (microstructure) and fixation plate hardness.

For total bilirubin assay kits, 1 batch failed, involving Ali Biotechnology Taizhou Co., Ltd. The noncompliance item was accuracy.

Regarding regulatory requirements, the NMPA has required the provincial drug regulatory authorities where the companies are located to follow the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Administration of Medical Device Recalls, promptly make administrative handling decisions and disclose them to the public. Provincial drug regulatory authorities should urge companies to conduct risk assessments on noncompliant products, determine the recall level according to the severity of the device defect, proactively recall products and publicly disclose recall information; urge companies to identify the causes of noncompliance as soon as possible, formulate corrective measures, and complete rectification on schedule.

For companies, the key is not only the noncompliance itself, but the closed loop of post-market sampling, risk assessment, recall, rectification, and QMS correction. Is your team ready? Let’s discuss.