CFDA issued the 24th Medical Device Quality Bulletin

In order to strengthen the quality supervision and management of medical equipment, to ensure the safe and effective use of medical equipment products, the State Food and Drug Administration Organization of the surgical clothing, one-time use of human venous blood collection containers and other four varieties of 110 approved (Taiwan ) Of the product quality supervision and sampling. Now the sampling results are as follows:

First, the sampling project does not meet the standards of medical equipment products, involving seven medical equipment manufacturing enterprises of the four varieties of seven batches (Taiwan). Specific:

(A) surgical clothing 3 enterprises 3 batches of products. Tianjin Tianjian Electronics Co., Ltd. production of a batch of one-time use of surgical clothing, impermeability (product key areas) does not meet the standards; (Product critical area), tensile strength, dry state (product critical area), tensile strength, wet (product critical area) does not meet the standard (The key areas of the product), tensile strength, dry state (non-critical areas of the product) do not meet the requirements of the standard.

(B) one-time use of human venous blood collection container 2 enterprises 2 batches of products. Shenyang Bao Kang Biological Engineering Co., Ltd. production of a batch of disposable vacuum blood collection tube, nominal liquid volume, scale mark and filling line does not meet Standard requirements; Jiangxi Shanggong County Fengxing medical supplies factory production of a batch of one-time use of vacuum blood collection tube, nominal liquid capacity does not meet the standard requirements.

(3) multi-parameter patient monitoring equipment 1 enterprise 1 batch of products. Shenzhen Jinke Granville Industrial Co., Ltd. produced a patient monitor, heart rate measurement range and accuracy does not meet the standard requirements.

(4) non-invasive automatic measurement of blood pressure monitor (electronic sphygmomanometer) 1 enterprise 1 product. Thai good Kang Electronic Technology (Fujian) Co., Ltd. production of an electronic sphygmomanometer, pressure sensor accuracy does not meet the standard requirements.

The above sampling does not meet the specific requirements of the product, see Annex 1.

Second, the sampling items for the identification of labels, brochures and other items do not meet the standards of medical equipment products, involving two medical equipment manufacturing enterprises of a variety of 2, specifically:

Non-invasive automatic measurement of sphygmomanometer (electronic sphygmomanometer) 2 companies 2 products. Wuhan City Kang Jier Electronics Co., Ltd. produced a non-invasive automatic measurement of blood pressure meter, Shandong Dongan Jin An Electronics Co., Ltd. produced a arm-type electronic blood pressure The marking requirements do not meet the standard requirements.

The above sampling does not meet the specific requirements of the product, see Annex 2.

Third, the sampling project all meet the standards of medical equipment products involving 63 medical equipment manufacturing enterprises of the two varieties of 101 batches (Taiwan), see Annex 3.

Fourth, the sampling found in the non-compliance with the provisions of the product, the national food drug Supervision and Administration has requested the location of enterprises and food and drug supervision and management departments in accordance with the "medical instruments Supervision and management of the Ordinance and the General Office of Food and Drug Administration on the further strengthening of medical equipment sampling work notice (Food and Drug Administration Supervision [2016] No. 9), the relevant enterprise To carry out investigation and handling.

The relevant medical equipment manufacturing enterprises should not meet the standard requirements of the product, do not meet the standard requirements of the project risk assessment, according to the severity of medical equipment defects to determine the recall level, take the initiative to recall and public recall information.Enterprise food and drug supervision and management departments to recall The case of supervision, the organization should not recall the recall should be recalled; if found to meet the standards of medical device products on the human body caused harm or evidence of possible harm to the human body health The relevant provincial food and drug supervision and management departments to urge enterprises to identify the cause as soon as possible, to develop corrective measures and rectification in place in time, the disposal of the situation in November 17, 2017 before the date of the implementation of the emergency control measures, Social publication, and timely reporting of the situation.

Special announcement.

Serial number	Mark the product name	Check the unit	Mark the production enterprise	Specifications Model	Production date / lot number / Serial number	Sampling unit	Inspection unit	Does not meet the standard requirements
1	One-time use Surgical clothing	Tianjin Tianjian Electronics Co., Ltd.	Tianjin Tianjian Electronics Co., Ltd.	Type A	May 10, 2016 /	Tianjin market and quality Supervisory Board	Beijing Medical Devices Laboratory	Impermeability (Product critical area)
2	One-time use Surgical clothing	Xining Modern Maternity Hospital Limited	Henan Province, Henan North Asahi Limited	Specifications: Large	December 12, 2014 20141203	Food and Drugs in Qinghai Province Supervisory Authority	Beijing Medical Devices Laboratory	1. Seepage resistance (product non-critical areas); 2. Tensile strength, dry state (product critical area); 3. Tensile strength, wet (product critical area)
3	One-time use Surgical clothing	Xinjiang Yi Fei Trade Co., Ltd	Xinjiang Yi Fei trade Limited company	Type B 120cm × 140cm	20160408/	Xinjiang Uygur Autonomous Region Food and Drug Administration	Henan Province Medical Device Testing Institute	1. Tensile strength, dry state (Product critical area); 2. Tensile strength, dry state (Non-critical areas of product)
4	One-time use Vacuum blood collection	Shenyang Bao Kang Biological Engineering Co., Ltd	Shenyang Bao Kang biological Engineering Co., Ltd	BKG720K2E	20160419 20160065	Liaoning Province Food and Drugs Supervisory Authority	Inner Mongolia Autonomous Region Medical Device Testing Center	Nominal liquid capacity 2. Marking and filling lines
5	One-time use Vacuum blood collection	Jiangxi Shanggao County Fengxing medical supplies factory	Jiangxi Shanggao County Fengxing medical supplies factory	EDTA K2	20160401/	Food and Drugs in Jiangxi Province Supervisory Authority	Fujian Province, medical equipment and pharmaceutical packaging materials testing	Nominal liquid capacity
6	Patient monitor	Yichang Kangyuan Technology Co., Ltd	Shenzhen City Kewei Granville Industrial Co., Ltd	G30	2013-12 CN32710906	Hubei Province Food and Drugs Supervisory Authority	Quality Supervision of Medical Devices in Guangdong Province Inspection	Heart rate measurement range and accuracy
7	Blood Pressure Monitor	Thai good Kang Electronics Technology (Fujian) Limited company	Thai good Kang Electronic Technology (Fujian) Co., Ltd.	XD188	/T1502001012	Food and Drugs in Fujian Province Supervisory Authority	Anhui Province Food and Drug Research Institute	Pressure sensor accuracy

Serial number	Mark the product name	Check the unit	Mark the production enterprise	Specifications Model	Serial number	Sampling unit	Inspection unit	Does not meet the standard requirements
1	Noninvasive automatic measurement sphygmomanometer	Wuhan City Kang Gil Electronics Co., Ltd.	Wuhan City Kang Gil Electronics Co., Ltd.	KG-C2	2016051005	Hubei Province Food and Drug Administration	Anhui Province Food and Drug Research Institute	Logo requirements
2	Arm type electronic sphygmomanometer	Shandong East A Kaman Electronics Co., Ltd.	Shandong East A Kaman Electronics Co., Ltd.	JN-163B	JN-163B20160300649	Shandong Province Food and Drug Administration	Anhui Province Food and Drug Research Institute	Logo requirements

Food and Drug Administration

October 20, 2017