NMPA Reports 16 Batches of Non-compliant Medical Devices in Latest Supervisory Inspection

To strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical device product quality, the National Medical Products Administration organized quality supervision inspections for 10 categories of products, including balance training equipment and rigid gas-permeable contact lenses for orthokeratology. Sixteen batches (units) of products did not meet the standard requirements. The specific situations are announced as follows:

I. Medical device products that fail to meet the standards in the sampling inspection

(1) One balance training device: produced by Huaxi Jingchuang Medical Technology (Chengdu) Co., Ltd., involving non-compliance of indicator light colors with standard regulations.

(II) 2 Dental X-ray Machines: Produced by Zhengzhou Qinjin Electronic Technology Company and Ziyang Ruiying Medical Device Co., Ltd., respectively, involving non-compliance with standard specifications for indicator light colors and ME equipment expected to be connected to a power source via a plug.

(III) One batch of disposable insulin pump subcutaneous infusion sets: produced by MicroTech Medical (Hangzhou) Co., Ltd., involving non-conformance to standard specifications for UV absorbance.

(4) One batch of rigid gas-permeable contact lenses for orthokeratology: produced by Shenzhen New Industries Material of Ophthalmology Co., Ltd., involving non-conformance to standard specifications for posterior vertex power.

(V) Polyurethane Foam Dressing 1 batch: Produced by Coloplast A/S, involving non-conformance to standard specifications for water vapor transmission rate.

(6) Three batches of soft contact lenses: produced by G&G Contact Lens, InterOjo Inc., and Zhuhai San Shi Optical Co., Ltd., respectively, involving base curve radius or sagittal height of a given base diameter not conforming to standard specifications.

(7) Two batches of plaster-type medical devices (far-infrared treatment patches, magnetic therapy patches, acupoint magnetic therapy patches, fever relief patches, acupoint pressure stimulation patches): produced by Anhui Zhongkang Pharmaceutical Co., Ltd. and Jiangxi Shuangfu Pharmaceutical Co., Ltd., were found to contain "drug components that should not be detected according to supplementary inspection methods."

(VIII) One batch of disposable sterile catheters: Produced by Guangdong Baihe Medical Technology Co., Ltd., involving non-conformance to standard specifications regarding the integrity and volume maintenance of the catheter inflation lumen.

(IX) Medical protective masks (3 batches): Produced by Hebei Baota Medical Device Co., Ltd., Henan Zhongsheng Xianghe Medical Supplies Co., Ltd., and Changdong Medical Device Group Co., Ltd., involving filtration efficiency not meeting the standard requirements.

(10) Human Chorionic Gonadotropin (HCG) Test Kit (Colloidal Gold Immunochromatography Assay) 1 batch: Produced by Guangzhou Decheng Biotechnology Co., Ltd., involving non-conformance to standard specifications for detection limit, specificity, and repeatability.

The specific details of the above-mentioned products that failed to meet the standard requirements are shown in the attachment.

II. Regulatory Requirements

Regarding the products found non-compliant with standards during sampling inspections, the National Medical Products Administration (NMPA) has required provincial medical products administration departments where the companies are located to promptly issue administrative decisions and make public announcements in accordance with the Regulations on the Supervision and Administration of Medical Devices, Measures for the Supervision and Administration of Medical Device Production, and Measures for the Administration of Medical Device Recalls. Provincial medical products administration departments must urge companies to conduct risk assessments on non-compliant products identified during sampling inspections, determine recall levels based on the severity of the medical device defects, proactively recall the products, and disclose recall information. Additionally, they should ensure that companies quickly identify the reasons for product non-compliance, formulate corrective measures, and fully implement them within the stipulated timeframe.

Hereby announced.

Attachment: List of Products Failing to Meet Standards in Sampling Inspection

National Medical Products Administration

September 22, 2025

Compiled by: TACRO

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