Circular of the State Food and Drug Administration on the Results of National Medical Device Supervision and Sampling (No. 4) (No. 63 of 2022)

In order to strengthen the supervision and management of medical devices and ensure the quality of medical device products, safety and effectiveness, the State Medical Products Administration organized product quality supervision and sampling inspection of 10 varieties such as electric wheelchairs, small steam sterilizers, and uric acid determination kits, and found that 29 batches (sets) of products did not meet the standard provisions
.

 

1.
Medical device products whose items are sampled do not meet the requirements of the standards

 

(1) 10 electric wheelchairs: Tianjin Taikang Sunshine Technology Development Co.
, Ltd.
, Meritz Medical Equipment (Suzhou) Co.
, Ltd.
, Mingguang Longway Medical Equipment Technology Co.
, Ltd.
, Langfang Taiwang Medical Equipment Co.
, Ltd.
, Ningbo Shenyu Medical Equipment Co.
, Ltd.
, Zhejiang INOVA Rehabilitation Equipment Co.
, Ltd.
, Bazhou Citizen Likang Medical Equipment Co.
, Ltd.
production, involving continuous leakage current and patient auxiliary current at normal working temperature, inhibition driving when charging, maximum speed, horizontal road braking, maximum safe slope braking The input power does not meet the standard regulations
.

 

(2) 1 small steam sterilizer: produced by Zhiwei (Xiamen) Instrument Co.
, Ltd.
, the steam temperature involving equilibrium time, maintenance time and maintenance time does not meet the standard regulations
.

 

(3) Uric acid determination kit 1 batch: produced by Ningbo Botai Biotechnology Co.
, Ltd.
, the accuracy involved does not meet the standard regulations
.

 

(4) 1 X-ray bone densitometer: produced by Hangzhou Yuanxiang Medical Equipment Co.
, Ltd.
, the voltage accuracy of the X-ray tube does not meet the standard regulations
.

 

(5) 1 dental implant machine: produced by Osstem Implant Co.
, Ltd.
, involving no-load speed that does not meet the standard regulations
.

 

(6) 6 sets of cold light sources for endoscopes: Shandong Guanlong Medical Supplies Co.
, Ltd.
, Nanjing Yanan Special Lighting Electrical Appliance Factory, Shenzhen Enop Medical Equipment Co.
, Ltd.
, Beijing Fanxing Optoelectronic Medical Equipment Co.
, Ltd.
, PolyDiagnost GmbH (German Boli Medical Technology Co.
, Ltd.
), Xuzhou Jiabao Electronic Technology Co.
, Ltd.
production, involving the radiated flux ratio of red, green and blue light, infrared cut-off performance, input power, samples can not be used normally during normal inspection does not meet the standard regulations
。

 

(7) Alginate dressing 2 batches: Hangzhou Jiwei Medical Technology Co.
, Ltd.
and Robust Medical Supplies Co.
, Ltd.
production, involving diffusion that does not meet the standard provisions
.

 

(8) 1 contrast agent injection device: produced by Shenzhen Dongda Precision Instrument Technology Development Co.
, Ltd.
, the maximum injection pressure involved does not meet the standard regulations
.

 

(9) 3 batches of surgical gowns: marked as produced by Xinxiang Hexie Medical Equipment Co.
, Ltd.
and Henan Asia-Pacific Medical Supplies Co.
, Ltd.
, involving sterility that does not meet the standard provisions
.

 

(10) 3 batches of sodium hyaluronate gel for injection: produced by Relais (Beijing) Medical Device Co.
, Ltd.
and CG Bio Co.
, Ltd.
fine-based biological Co.
, Ltd.
, the content of free sodium hyaluronate does not meet the standard provisions
.

 

The above sampling does not meet the standard requirements, and the specific conditions of the products are shown in the annex
.

 

2.
For the above-mentioned products that do not meet the standards, the State Medical Products Administration has required the provincial drug regulatory department where the medical device registrant is located to make administrative processing decisions in a timely manner and announce
them to the public in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Administrative Measures for the Recall of Medical Devices 。 The provincial drug regulatory department shall urge the medical device registrant to conduct a risk assessment of the products that do not meet the requirements of the standards, determine the recall level according to the severity of the medical device defect, actively recall the products and disclose the recall information; Supervise and urge enterprises to find out the reasons for unqualified products as soon as possible, formulate corrective measures and put rectification in place
on schedule.

 

Notice is hereby given
.

 

Attachment: List of products that do not meet the standard requirements for random inspection

serial number	Label the product name	Spot checked	Indicate the medical device registrant and recordation holder	Specifications and models	Date of manufacture/batch number/factory number	sampling	Inspection	Non-compliance with standard provisions
1	Electric wheelchair car	Shanxi Kangwanjia Medical Equipment Chain Co. , Ltd	Tianjin Taikang Sunshine Technology Development Co. , Ltd	DYW-459-46A3	2021/6/11 210428 216	Shanxi Provincial Drug Administration	Shaanxi Medical Device Quality Inspection Institute	Suppress driving while charging
2	Electric wheelchair car	Daqing Dongfeng Pharmacy Chain Co. , Ltd. Tongcheng Pharmacy	Tianjin Taikang Sunshine Technology Development Co. , Ltd	DYW-459-46A5	2020/1/17 20 /190705	Heilongjiang Provincial Drug Administration	Shaanxi Medical Device Quality Inspection Institute	Suppress driving while charging
3	Electric wheelchair car	Tianjin Taikang Sunshine Technology Development Co. , Ltd	Tianjin Taikang Sunshine Technology Development Co. , Ltd	DYW-459-46A10	2022/1/5 211205 001	Tianjin Drug Administration	Shaanxi Medical Device Quality Inspection Institute	Input power; Suppress driving while charging
4	Electric wheelchair car	Meritz Medical Devices (Suzhou) Co. , Ltd	Meritz Medical Devices (Suzhou) Co. , Ltd	P103	2020-02-23TNX200200005	Jiangsu Provincial Drug Administration	Hunan Institute of Drug Inspection and Testing	Continuous leakage current and patient auxiliary current at normal operating temperature
5	Electric wheelchair car	Tibet Zhanbo Medical Equipment Co. , Ltd	Mingguang Longway Medical Device Technology Co. , Ltd	LW01301A	December 6, 2021 20211206 20211206010	Tibet Autonomous Region Drug Administration	Shaanxi Medical Device Quality Inspection Institute	maximum speed; horizontal road braking; Maximum safe slope braking
6	Electric wheelchair car	Langfang Taiwang Medical Equipment Co. , Ltd	Langfang Taiwang Medical Equipment Co. , Ltd	TW-100W	20220401 April 22, 2022	Hebei Provincial Drug Administration	Shaanxi Medical Device Quality Inspection Institute	Continuous leakage current and patient auxiliary current at normal operating temperature; maximum speed; horizontal road braking; Maximum safe slope braking
7	Electric wheelchair car	Ningbo Shenyu Medical Equipment Co. , Ltd	Ningbo Shenyu Medical Equipment Co. , Ltd	W-A805	2021. 5 N0022104 N0022104075	Zhejiang Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	Maximum speed
8	Electric wheelchair car	Zhejiang INOVA Rehabilitation Equipment Co. , Ltd	Zhejiang INOVA Rehabilitation Equipment Co. , Ltd	N5909	March 02, 2022 B140203909022100	Zhejiang Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	Input power
9	Electric wheelchair car	Hubei New Special Medicine Pharmacy Chain Co. , Ltd	Zhejiang INOVA Rehabilitation Equipment Co. , Ltd	N5516	2021 April 12, 12	Hubei Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	Input power
10	Electric wheelchair car	Bazhou citizen Likang Medical Equipment Co. , Ltd	Bazhou citizen Likang Medical Equipment Co. , Ltd	BM-100W	December 2022, 4 12 220401	Hebei Provincial Drug Administration	Shaanxi Medical Device Quality Inspection Institute	maximum speed; horizontal road braking; Maximum safe slope braking
11	Benchtop automatic pressure steam sterilizer	Zhiwei (Xiamen) Instrument Co. , Ltd	Zhiwei (Xiamen) Instrument Co. , Ltd	18L/GT18DP	2017. 08. 07 E416D003	Fujian Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	equilibrium time; Duration of maintenance; Steam temperature for holding time
12	Uric acid assay kit (enzyme colorimetry)	Ningbo PATEO Biotechnology Co. , Ltd	Ningbo PATEO Biotechnology Co. , Ltd	Reagent 1: 66 ml×6; Reagent 2: 16 ml×6; Calibrator: 1 ml	2021 April 10, 09	Zhejiang Provincial Drug Administration	Shanghai Institute of Medical Device Inspection and Research	accuracy
13	Dual-energy X-ray bone densitometer	Hangzhou Yuanxiang Medical Equipment Co. , Ltd	Hangzhou Yuanxiang Medical Equipment Co. , Ltd	G3	2022. 04. 06 GMG3220328001	Zhejiang Provincial Drug Administration	Liaoning Medical Device Inspection and Testing Institute	X-ray tube voltage accuracy
14	Dental Surgical Devices	Aoyatai (Beijing) Trading Co. , Ltd	Osstem Implant Co. , Ltd.	SM5	2021-12-08 1005567	Beijing Municipal Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	No-load speed
15	Medical cold light source	Shandong Guanlong Medical Supplies Co. , Ltd	Shandong Guanlong Medical Supplies Co. , Ltd	YL-Ⅲ	2021. 10. 19 21101501 21016	Shandong Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	The radiated flux ratio of red, green and blue light
16	Medical cold light source	Nanjing Yanan Special Lighting Electrical Appliance Factory	Nanjing Yanan Special Lighting Electrical Appliance Factory	XD-302-250W	2022 April 03, 31	Jiangsu Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	Infrared cut-off performance
17	Medical endoscope cold light source	Shenzhen Inop Medical Equipment Co. , Ltd	Shenzhen Inop Medical Equipment Co. , Ltd	INP-LUM300	2022-04-12 INP2022041300102	Guangdong Provincial Drug Administration	Zhejiang Medical Device Inspection and Research Institute	The radiated flux ratio of red, green and blue light
18	Medical endoscope cold light source	Beijing Fanxing Optoelectronics Medical Equipment Co. , Ltd	Beijing Fanxing Optoelectronics Medical Equipment Co. , Ltd	XD-250	20220411 X02220201	Beijing Municipal Drug Administration	Shandong Medical Device and Drug Packaging Inspection and Research Institute	Input power
19	Cold light source for endoscopes	Shanghai Blue Line Electronics Co. , Ltd	PolyDiagnost GmbH	PD-LS-0220	2021-03-29 64194755	Shanghai Municipal Drug Administration	Zhejiang Medical Device Inspection and Research Institute	Samples cannot be used properly during normal testing
20	LED medical endoscope cold light source	Xuzhou Jiabao Electronic Technology Co. , Ltd	Xuzhou Jiabao Electronic Technology Co. , Ltd	L50A	2022. 3 2203002	Jiangsu Provincial Drug Administration	Guangdong Institute of Quality Supervision and Inspection of Medical Devices	The radiated flux ratio of red, green and blue light
21	Alginate dressings	Hangzhou Jiwei Medical Technology Co. , Ltd	Hangzhou Jiwei Medical Technology Co. , Ltd	10cm×10cm	20211227 CG-001-211201	Zhejiang Provincial Drug Administration	Shandong Medical Device and Drug Packaging Inspection and Research Institute	Diffuse
22	Alginate dressings	Robust Medical Supplies Co. , Ltd	Robust Medical Supplies Co. , Ltd	High gel type 10cm×10cm	2021-11-28 20211128	Guangdong Provincial Drug Administration	Shandong Medical Device and Drug Packaging Inspection and Research Institute	Diffuse
23	Contrast agent high-pressure syringe	Shenzhen Dongda Precision Instrument Technology Development Co. , Ltd	Shenzhen Dongda Precision Instrument Technology Development Co. , Ltd	DDI-400C	2022-04-15 D22C2000190	Guangdong Provincial Drug Administration	Liaoning Medical Device Inspection and Testing Institute	Maximum injection pressure
24	Single-use surgical gowns	Kuitun Hospital of Traditional Chinese Medicine of Xinjiang Production and Construction Corps	Xinxiang Hexie Medical Equipment Co. , Ltd	120cm×120cm	2021 April 10, 8	Xinjiang Production and Construction Corps Drug Administration Bureau	Yunnan Medical Device Inspection and Research Institute	asepsis
25	Single-use medical surgical gowns	Guyuan Aier Eye Hospital	Henan Asia-Pacific Medical Supplies Co. , Ltd	tuba	2021 April 11, 2	Ningxia Hui Autonomous Region Drug Administration	Yunnan Medical Device Inspection and Research Institute	asepsis
26	Single-use medical surgical gowns	The First People's Hospital of Korla City	Henan Asia-Pacific Medical Supplies Co. , Ltd	tuba	2021 April 2, 20	Xinjiang Uygur Autonomous Region Drug Administration	Yunnan Medical Device Inspection and Research Institute	asepsis
27	Cross-linked sodium hyaluronate gel for injection	Relais (Beijing) Medical Equipment Co. , Ltd	Relais (Beijing) Medical Equipment Co. , Ltd	1. 0mL	211119 211101 D2435-D2449	Beijing Municipal Drug Administration	China Academy of Food and Drug Control	Free sodium hyaluronate content
28	Cross-linked sodium hyaluronate gel for injection	Shanghai Hongkang Hospital Co. , Ltd	CG Bio Co. , Ltd	Model: DANAE Line Z1 Specification: 1. 0ml/pcs/box	2021-04-09 C1054J1	Shanghai Municipal Drug Administration	China Academy of Food and Drug Control	Free sodium hyaluronate content
29	Cross-linked sodium hyaluronate gel for injection	Beijing Weiner Medical Beauty Clinic	CG Bio Co. , Ltd	1. 0ml/pc/box DANAE Line Z1	2021-03-26 C1053J1	Beijing Municipal Drug Administration	China Academy of Food and Drug Control	Free sodium hyaluronate content

 

State Food and Drug Administration

 

January 3, 2023