On July 31, the National Medical Products Administration (NMPA) made a significant announcement via their official WeChat account regarding their enhanced oversight of medical devices. This initiative aims to guarantee the quality and safety of these essential products. As part of this effort, the NMPA conducted inspections on 17 different types of medical devices, uncovering that 24 batches were found to be non-compliant. Let’s delve into the specifics of these findings.
First, a **Semiconductor Laser Therapy Machine** from Nanjing Yigao Medical Technology Co., Ltd. did not meet standards related to the laser preparation indicator and the remote interlock connector.
Next, in the category of **High-Frequency Electro-Surgical Devices**, two units from Gebrüder Martin GmbH & Co. KG and Nanjing Shouliang Medical Technology Co., Ltd. showed deficiencies due to high-frequency leakage current and patient auxiliary current during normal operation.
Regarding **Intense Pulsed Light Therapy Devices**, two units from Active Optical Systems Ltd. and Gu’an Yiguang Technology Co., Ltd. were found non-compliant for input power and pulse energy density requirements.
A **Medical Oxygen Concentrator** from Baoding Maizhuo Medical Equipment Co., Ltd. failed to meet standards concerning enclosure integrity, safety for covers, and leakage current measures.
In the realm of **Medical Pulse Oximeters**, three units from Hunan Guojian Medical Devices Co., Ltd., Shanghai Beirui Electronic Technology Co., Ltd., and Chongqing Rutai Technology Co., Ltd. were found lacking in both pulse rate accuracy and signal integrity.
For **Infusion Pumps**, two units from Nanjing Yingmani Medical Technology Co., Ltd. and Shenzhen Micotian Biomedical Technology Co., Ltd. did not comply with the required alarm functionalities and audible alarm signals.
A batch of **Scar Repair Gel** from Jiangsu Qiuheng Medical Devices Co., Ltd. was noted for its pH level non-compliance.
In **Arthroscopy**, one batch from ConMed Corporation was found deficient in color resolution and comprehensive light efficacy.
**Stone Retrieval Baskets** from Guangdong Tianyou Medical Technology Development Co., Ltd. and Shenzhen Kangyibo Technology Development Co., Ltd. both failed to meet tensile strength standards.
Concerning **Soft Contact Lenses**, one batch from Wangsun Technology Co., Ltd. did not conform to specifications for base arc radius or bottom diameter.
Two batches of **Hydrocolloid Dressings** from Paul Hartmann AG and Guangdong Tidakang Medical Technology Co., Ltd. were non-compliant due to liquid absorption capacity issues.
An **Adhesive Medical Device** batch from Chongqing Hao Ai You Pharmaceutical Technology Co., Ltd. showed non-compliance due to prohibited substances being detected based on supplementary inspection methods.
In the **Thrombectomy Catheters** category, one batch from Guangzhou Yijie Medical Technology Co., Ltd. failed to meet ultraviolet transparency levels.
One batch of **Medical Face Masks** from Hubei Changdi Medical Technology Co., Ltd. did not achieve the required filtration efficiency.
Additionally, a batch of **Disposable Medical Protective Clothing** from Hunan Yongfei Special Protective Products Co., Ltd. did not pass for anti-static properties.
An **Orthodontic Wire** batch from Hangzhou Xihu Biomaterial Co., Ltd. was lacking compliance in yield bending force and bending stiffness standards.
Finally, a **Lipoprotein(a) Test Kit** from Ningbo Bote Biotechnology Co., Ltd. failed to meet established accuracy standards.
In response to these findings, the NMPA has mandated provincial drug supervisory authorities to take immediate administrative action as outlined in the Medical Device Supervision Management Regulations and other relevant laws. Provincial bodies are tasked with ensuring that companies assess the risks linked to these non-compliant products, determine appropriate recall measures based on the severity of defects, and implement corrective actions within designated timelines.
