NMPA Announcement on National Medical Device Supervision and Sampling Inspection Results (No. 35 of 2025)

(Source: China Food and Drug Administration Network)

To strengthen the supervision and management of medical devices and ensure the safety, efficacy, and quality of medical device products, the National Medical Products Administration organized a quality supervision inspection for 10 categories of products, including balance training equipment and rigid gas-permeable contact lenses for orthokeratology. A total of 16 batches (units) of products did not meet the standard requirements. The specific details are announced as follows:

I. Medical device products with sampled items failing to meet the specified standards

(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 Qinjing Electronic Technology Development Co., Ltd. and Ziyang Ruiying Medical Device Co., Ltd., respectively, involving non-compliance with standard specifications for indicator light colors and ME equipment intended to be connected to a power source via a plug.

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

(4) One batch of rigid gas-permeable contact lenses for orthokeratology: ShenzhenSznimoProduced by Shenzhen New Industries Material of Ophthalmology Co., Ltd., involving posterior vertex power not meeting standard specifications.

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

(VI) 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 for 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 ingredients 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) Diagnostic 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 to be non-compliant with standard regulations during sampling inspections, the National Medical Products Administration (NMPA) has required provincial-level medical products administration departments in the enterprises' locations to promptly issue administrative decisions and disclose them to the public according to 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-level medical products administration departments must urge enterprises to conduct risk assessments on non-compliant products identified during sampling inspections, determine the recall level based on the severity of the medical device defects, proactively recall the products, and publicly disclose recall information. They must also ensure that enterprises quickly identify the reasons for product non-compliance, develop corrective measures, and fully implement these measures within the specified timeframe.

Hereby announced.