NMPA Releases Announcement No. 26 of 2026 on National Medical Device Supervision Inspection | 8 Batches/Units Fail to Meet Standards

On July 23, 2026, the National Medical Products Administration (NMPA) officially released the "Announcement on the Results of National Medical Device Supervision Inspection (No. 26 of 2026)." The inspection covered 4 product categories—low- and medium-frequency therapy devices, surgical electrodes (high-frequency bipolar), sleep apnea therapy devices, and medical sodium hyaluronate dressings—and found that 8 batches/units failed to meet the standard requirements.

Details of non-compliant products:

I. Low- and Medium-Frequency Therapy Devices (3 units)

l Beijing Yaoyang Kangda Medical Instrument Co., Ltd. — Spasm Muscle Low-Frequency Therapy Apparatus (Model KX-3A): failed on "operating parts of ME equipment controls";

l Shandong Aiweide Biotechnology Co., Ltd. — Medium-Frequency Therapy Device (Model AWD-F): failed on "indicators and controls," "indicators," "output," and "output indication";

l Zhongshan Jianikang Intelligent Electronics Co., Ltd. — Medium-Frequency Therapy Device (Model JYK-025): failed on "output indication."

II. Surgical Electrodes (High-Frequency Bipolar) (1 unit)

l Hebei Zhongbang Tiancheng Medical Device Technology Co., Ltd. — Single-Use High-Frequency Electrode (Model GD-Nw190): failed on "human error."

III. Sleep Apnea Therapy Devices (3 units)

l Hebei Mai Siwei Medical Equipment Co., Ltd. — Sleep Ventilator (Model M01): failed on "requirements for increase of audible sound energy" and "airway pressure measurement (pressure accuracy only)";

l Hunan Mingkang Zhongjin Medical Technology Co., Ltd. — Positive Airway Pressure Therapy Device (Model RM-C60) and Non-Invasive Ventilator (Model RM-T90): both failed on "requirements for increase of audible sound energy."

IV. Medical Sodium Hyaluronate Dressings (1 batch)

l Henan Runling Pharmaceutical Co., Ltd. — Medical Sodium Hyaluronate Dressing (25g): failed on "pH" and "viscosity."

Regulatory Actions

The NMPA has required provincial-level medical products administration authorities at the enterprises' locations to take administrative actions in accordance with the law, urge companies to conduct risk assessments on non-compliant products, determine recall levels based on the severity of defects, proactively recall products and disclose recall information, and promptly identify the root causes of non-compliance, implement corrective measures, and complete rectification within the prescribed timeline.