To strengthen the quality supervision and management of medical devices and ensure the safe and effective use of medical device products, the National Medical Products Administration has organized quality supervision sampling inspections and follow-up inspections on 703 batches (units) of 25 product categories, including metal bone plates, infant incubators, and therapeutic ventilators. The results of these inspections are hereby announced as follows:

　　1. For medical device products found to be non-compliant with standard specifications during the follow-up sampling inspections, the provincial food and drug administration authorities where the enterprises are located shall impose strict penalties in accordance with the law, ordering the manufacturing enterprises to halt production and rectify the affected product specifications and models, and to recall all batches of the same model. At the same time, these authorities shall organize supervisory inspections of the manufacturing enterprises. If any deficiencies in the enterprise’s quality management system are identified that could potentially affect the quality of other products, the authorities shall immediately order the enterprise to completely suspend production and operations for comprehensive rectification. The relevant handling measures shall be promptly disclosed to the public. Enterprises whose causes remain unidentified or whose corrective actions have not been fully implemented shall be strictly prohibited from resuming production.

　　(1) The disposable infusion set—complete with needle—produced by Honghu Taining Medical Device Co., Ltd. does not comply with the standard specifications regarding the drip chamber and drip tube.

　　(2) The disposable infusion set with needle manufactured by Shengguang Medical Products Co., Ltd. does not comply with the standard specifications.

　　(3) The disposable infusion set—with needle—manufactured by Shenyang Fengda Medical Device Co., Ltd. has color markings that do not comply with the standard specifications.

　　(4) The natural latex rubber condoms produced by Jinjiang Kangle Latex Products Co., Ltd. do not meet the standard specifications for burst volume and pressure after aging.

　　For details on the specific products that failed to meet the standard requirements in the above-mentioned follow-up inspections, please refer to Attachment 1.

　　II. For products found to be non-compliant with standard requirements during the spot checks listed below, the food and drug administration department in the enterprise’s location shall impose administrative penalties—including warnings, fines, confiscation of illegal gains, confiscation of illegal property, and orders to suspend production and business operations—in accordance with relevant provisions such as the “Regulations on the Supervision and Administration of Medical Devices” (State Council Order No. 650).

　　For products that do not meet the prescribed standards, the relevant medical device manufacturers shall conduct a risk assessment on the non-compliant items, determine the recall level based on the severity of the medical device defects, and proactively carry out recalls while publicly disclosing recall information. The food and drug administration department in the manufacturer’s location shall supervise the recall efforts undertaken by the company; if the company fails to organize a recall, it shall be ordered to do so immediately. In cases where non-compliant medical device products have caused harm to human health or there is evidence suggesting they may pose a risk to human health, the food and drug administration department may adopt emergency control measures, including suspending production, import, distribution, and use. The relevant provincial food and drug administration departments shall urge the companies to identify the root causes, develop corrective measures, and set deadlines for rectification. By April 30, 2016, these departments shall publicly disclose to the public the details of the actions taken.