National Medical Device Quality Announcement (16th issue, total 34th issue, 2017)

In order to strengthen the quality supervision and management of medical devices and ensure the safe and effective use of medical device products, the State Food and Drug Administration organized quality supervision and sampling inspections of 150 batches (units) of five varieties including synthetic resin teeth and high-frequency electric knives. The sampling results are hereby announced as follows:

1、 The medical device products sampled do not meet the standard requirements, involving 14 batches of 2 varieties from 9 medical device manufacturers. Specifically:

（1） Three companies produced four batches of synthetic resin teeth. The size of one batch of synthetic resin teeth produced by Shengzhou Xingwang Dental Materials Factory does not meet the standard requirements; One batch of hard resin teeth produced by Nissin Dental Co., Ltd. (represented by Nichin Dental Materials (Kunshan) Co., Ltd.) did not meet the standard requirements for anti whitening, anti deformation, and anti micro cracking; Two batches of multi-layer color synthetic resin teeth produced by Anyang Dimei Dental Materials Factory do not meet the standard requirements for porosity and other defects.

（2） 10 batches of sterile vaginal dilators from 6 companies. The first batch of sterile vaginal dilators produced by Nanchang Xuhui Medical Equipment Co., Ltd. did not meet the standard requirements for structural strength; One batch of sterile vaginal dilators produced by Nanchang Aibo Medical Equipment Co., Ltd. and three batches produced by Nanchang Yimin Medical Health Materials Co., Ltd. do not meet the standard requirements in terms of structural strength and deformation resistance; The structural strength of three batches of sterile vaginal dilators produced by Nanchang Fukang Medical Equipment Co., Ltd. does not meet the standard requirements, and one batch of them does not meet the standard requirements for deformation resistance; The residual amount of ethylene oxide in one batch of sterile biplane vaginal dilators produced by Guangxi Beilunhe Medical Industry Group Co., Ltd. and one batch of sterile vaginal dilators produced by Zhejiang Jinghuan Medical Supplies Co., Ltd. do not meet the standard requirements.

The specific situation of the products that do not meet the standard requirements during the above sampling inspection is shown in Annex 1.

2、 The sampled items are medical device products with identification labels, instructions, and other items that do not meet the standard requirements, involving 4 units of 1 variety from 4 medical device manufacturing enterprises. Specifically:

Four high-frequency electric knives were produced by four companies. One high-frequency electric knife produced by Beijing Beilin Electronics Co., Ltd. and Beijing Yakokanda Medical Technology Co., Ltd., one high-frequency surgical system and accessories produced by Soering GmbH (represented by Xisel (Beijing) Technology Development Co., Ltd.), and one ARC400 electrosurgical energy system produced by BOWA electronic GmbH&Co. KG (represented by Beijing Shenghetian Technology Co., Ltd.), the external markings of the equipment or equipment components do not comply with the standard requirements.

The specific situation of the products that do not meet the standard requirements during the above sampling inspection is shown in Annex 2.

3、 All medical device products that meet the standard requirements for sampling inspection involve 132 batches (units) of 5 varieties from 69 medical device manufacturing enterprises, as shown in Annex 3.

4、 For the products found to be non compliant with the standards during the above-mentioned inspections, the State Food and Drug Administration has requested the local food and drug supervision and management departments where the enterprises and agents are located to investigate and handle the relevant enterprises in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Notice of the General Office of the State Food and Drug Administration on Further Strengthening the Sampling and Inspection of Medical Devices" (Food and Drug Administration Office Medical Supervision [2016] No. 9).

Medical device manufacturers should conduct risk assessments on products and projects that do not meet standard requirements, determine recall levels based on the severity of medical device defects, proactively recall and publicly disclose recall information. The food and drug supervision and administration department where the enterprise and agent are located shall supervise the recall situation of the enterprise. If the recall is not organized, it shall be ordered to recall; If it is found that medical device products that do not comply with standard regulations cause harm to the human body or there is evidence that they may harm human health, emergency control measures such as suspending production, import, operation, and use can be taken. The relevant provincial food and drug supervision and management departments should urge enterprises to identify the reasons as soon as possible, formulate rectification measures, and rectify them on schedule. The relevant disposal situation should be announced to the public before August 20, 2017.

This is to announce.

Attachment: 1. List of products that do not meet the standard requirements for medical device sampling inspection

2. List of products that do not meet the standard requirements for medical device sampling (labeling, instructions, etc.)

3. List of products that meet the standard requirements for medical device sampling inspection

Food and Drug Administration

July 19, 2017