CFDA – 47 ENTERPRISES WERE CHASTISED IN THE CFDA QUALITY ANNOUNCEMENT

On March 11, 2016, the CFDA has released its first issue (nine in total) of national medical device quality announcement, which published the results of quality supervision sample tracking test of 703 batches (sets) of products of 25 types such as metallic bone plates, infant incubators and therapeutic respirators.

The following cases which failed to meet the standards were disclosed:

1. 1. 4 batches of medical devices of 2 types produced by 4 medical device manufacturers failed to meet the standard requirements in the sample tracking test;
   2. The sampling and testing items of 34 batches (sets) of medical devices of 16 types produced by 29 medical device manufacturers failed to meet the standard requirements;
   3. The sample inspection items such as tags, labels and manuals of 15 batches (sets) of medical devices of 5 types produced by 14 medical device manufacturers failed to meet the standard requirements.

The details:

1.The medical device products that failed to meet the standard requirements in the sample tracking test:

1. 1.  Disposable infusion sets (needle-included) manufactured by Honghu Taining Medical Device Co., Ltd.
   2. Disposable infusion sets (needle-included) manufactured by Shengguang Medical Instrument Co., Ltd.
   3. Disposable infusion sets (needle-included) manufactured by Shenyang Fengda Medical Device Co., Ltd.
   4. Natural latex rubber condoms manufactured by Jinjiang Kangle Latex Products Co., Ltd.

Punitive measures

Regarding to the medical device products that failed to meet the standard requirements in the sample tracking test mentioned above, the enterprises should be strictly punished by local provincial Food and Drug Administration in accordance with the law. The manufacturers should be ordered to suspend production and rectify the products of relevant specifications and models, and recall all batches of products of the same models. Meanwhile, supervisions and inspections on the manufacturers should be conducted. The manufacturers whose production quality management systems may cause quality problems to other products should immediately suspend all production and operation for rectification. The relevant punitive progress should be timely announced to the public. The production can be resumed only after the causes are identified and the rectification is carried out.

2.The sample inspection items of 34 batches (sets) of medical devices of 16 types produced by 29 medical device manufacturers failed to meet the standard requirements, in detail:

1. 1. 3 batches of disposable sterile infusion sets (needle-included) manufactured by Shenyang Fengda Medical Device Co., Ltd, Fujian Rende Medical Device Manufacturing Co., Ltd and Changzhou Huichun Medical Equipment Co., Ltd.
   2. 2 batches of metallic bone plates manufactured Taizhou Zhongxing Medical Device Technology Co., Ltd and Beijing Libeier Bio-engineering Institute Co., Ltd.
   3. 1 set of infant incubators manufactured by Shanghai Siling Medical Thermostatic Equipment Co., Ltd.
   4. 2 sets of Nd: YAG laser therapy apparatus manufactured by Chongqing Jingyu Laser Technology Co., Ltd and Sichuan Aerospace Shidu Guidance Co., Ltd.
   5. 4 sets of operating microscopes manufactured by Shanghai Yide Medical Equipment Co., Ltd, Suzhou 66 Vision Technology Inc and Chengdu Corder Optics & Electronics Co., Ltd.
   6. 2 sets of ultrasonic physiotherapy equipment manufactured by Shenzhen Well.D Medical Electronics Co., Ltd and Chengdu Kangfu Scientific Instrument Co., Ltd.
   7.  1 set of anaesthesia systems manufactured by Nanjing Puao Medical Equipment Co., Ltd.
   8. 5 batches of dental non-noble metal casting alloy (contains ceramic alloy) manufactured by RUBY joint-stock corporation, Nantong Today’s High-tech Materials Co., Ltd and Kennasitaili Metal (Shanghai) Co., Ltd.
   9.  1 set of therapeutic respirators manufactured by Jiangsu Aokai Medical Equipment Co., Ltd.
   10. 1 set of optometry units manufactured by Shanghai Supore Instruments Co., Ltd.
   11. 1 batch of ALT determining reagents (alanine substrate method) manufactured by Anhui Xinling Laboratory Medicine Science and Technology Co., Ltd.
   12. 3 batches of rubella virus IgG antibody detection reagents (enzyme linked immunosorbent assay and chemiluminescence method) manufactured by Zhuhai S.E.Z Haitai Biological Pharmaceuticals Co., Ltd, Beijing Tigsun Diagnostics Co., Ltd and Beijing Kewei Clinical Diagnostic Reagent Inc.
   13. 2 batches of CRE determining reagents (sarcosine oxidase method) manufactured by China Diagnostics Medical Corporation and Sichuan Xinjian Kangcheng Biological Co., Ltd.
   14. 2 batches of cytomegalovirus IgG antibody detection reagents (enzyme linked immunosorbent assay and chemiluminescence method) manufactured by Beijing Modern Gaoda Biotechnology Co., Ltd and Yingnuote (Tangshan) Biotechnology Co., Ltd.
   15. 1 batch of Glu determining reagents (hexokinase method and glucose oxidase method) manufactured by Hunan Yonghe-Yangguang Science and Technology Co., Ltd
   16. 3 batches of AST determining reagents manufactured by Siemens Healthcare Diagnostics Inc., Sichuan Xinjian Kangcheng Biological Co., Ltd and Anhui Xinling Laboratory Medicine Science and Technology Co., Ltd.

3.The sample inspection items such as tags, labels and manuals of 15 batches (sets) of medical devices of 5 types produced by 14 medical device manufacturers failed to meet the standard requirements, in detail:

1. 1. 4 sets of ultrasonic tooth cleaning equipment manufactured by Guangzhou Conghua Shenghua Industry Co., Ltd, Guilin Yikeshi Machine Co., Ltd and Xianyang Northwest Medical Device (Group) Co., Ltd.
   2. 1 set of ultrasonic physiotherapy equipment manufactured by Chengdu Kangfu Scientific Instrument Co., Ltd.
   3. 2 sets of microwave therapeutic equipment manufactured by Nanjing Sanle Electromechanical Technology Institute Co., Ltd and Nanjing Viking Jiuzhou Medical Device R&D Center.
   4. 1 set of medical ultrasonic atomizers manufactured by Nanjing Dauphin Electronics Co., Ltd.
   5. 7 sets of therapeutic respirators manufactured by Jiangsu Aokai Medical Equipment Co., Ltd, Nanjing Puao Medical Equipment Co., Ltd, Jiangsu Landsky Medical Equipment Co., Ltd, Shandong Ruide Tongyuan Medical Instrument Co., Ltd, Shenzhen PROBE Science & Technology Co., Ltd and SALVIA medical GmbH &Co.KG.

Punitive Measures

Regarding to the products that failed to meet the standard requirements in the sample test mentioned above, the local Food and Drug Administrations should impose warnings, penalties and confiscation of illegal gains or properties, ordering suspension of production and operation and other administrative punishments in accordance with the “Medical Device Supervision and Management Regulations” (Decree of the State Council No, 650).

For the unqualified products, relevant medical device manufacturers should conduct risk assessments on the unqualified items, determine the recall level based on the extent of the defects of medical devices, recall voluntarily and announce the recall information to the public. The local Food and Drug Administrations should supervise the recall progress, and impose recall orders on enterprises who haven’t yet recalled.

If the unqualified medical device products were found to cause harm to humans or have proven to damage public health, the Food and Drug Administration can employ emergency control measures such as suspending manufacturing production, importation, operation and usage. The relevant provincial Food and Drug Administrations should urge the companies to identify the causes, formulate rectification measures, and rectify within a time limit. The relevant handling progress will be announced to the public before April 30, 2016.