The final meeting for the Project of US FDA Medical Device Warning Letter System and Case Studies was successful held by China Association for Medical Devices Industry in Beijing on 29 December, 2020. The purpose of the meeting is to translate, analyze and study the FDA warning letter system and the warning letter cases released by the FDA in recent years. This will help to improve the medical device inspection system and mechanism, optimize inspection process, standardize content and format of inspection reports, strengthen the application of inspection results, and provide assistance in information disclosure and further improvement of inspector training.
The meeting was attended by relevant personnel from Department of Medical Device Supervision of National Medical Products Administration (NMPA), Food and Drug Inspection Center of the National Medical Products Administration, Medical Device Production Supervision Office of Beijing Municipal Medical Products Administration, Center for Certification and Evaluation Center of Jiangsu Medical Products Administration, and China Association for Medical Devices Industry, and representatives from Shanghai MicroPort Medical (Group) Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Micro-Tech (Nanjing) Co., Ltd., Poco International Medical Trade (Shanghai) Co., Ltd., Maquet (Shanghai) Medical Equipment Co., Ltd., Gore Industrial Products Trade (SHANGHAI) Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Siemens Healthineers AG, Becton Dickinson Medical Devices (Shanghai) Co., Ltd., Smith & Nephew Medical (Shanghai) Limited. and Johnson (Shanghai) medical equipment Co., Ltd. The meeting was held online and offline simultaneously, with 20 on-site representatives and 10 online representatives participating at the same time. The meeting was presided over by Yang Xiaofang, the deputy secretary general of CAMDI.
During the meeting, Li Yong, the head of the project group and vice president of Shanghai MicroPort Medical (Group) Co., Ltd. reported on the work carried out since the beginning of the project. By focusing on the significance of the project research, the FDA regulation history, the FDA warning letter system and case analysis, Mr. Li discussed non-conformities and non-conforming clauses/processes issued by FDA in its warning letters in recent years. He also provided suggestions for improving the inspection of medical devices in China.
The experts attending the meeting fully recognized the results of the research project, and put forward comments and suggestions for revision.
Finally, Shi Lei, Deputy Director of the Food and Drug Inspection Center of the National Medical Products Administration, gave a summary of the meeting. Shi pointed out that the purpose of this project is to draw upon the experiences suitable for China’s national conditions through the study of the US FDA warning letter system. The disclosure of government information in China is essentially the same as the warning letter system in the United States, as both are designed to benefit the people. However, they are also a double-edged sword due to the influence of public opinions. We have much to learn from the philosophy and regulatory methods and models of FDA. Meanwhile, the study process is also one in which international exchanges for risks of medical devices are conducted. We also need to explore standards for the boundary between the issuance of warning letters and treating a case as a general issue, and clarify the conditions, time limit, and content of the disclosure of information on unannounced inspection in a more detailed manner. During this project, an in-depth study was conducted on the US FDA warning letter system, the requirements of the project were met, and the expected purpose was achieved. The study results of this project will continue to be used in future supervision practices so as to continuously improve the supervision level.
The meeting was attended by relevant personnel from Department of Medical Device Supervision of National Medical Products Administration (NMPA), Food and Drug Inspection Center of the National Medical Products Administration, Medical Device Production Supervision Office of Beijing Municipal Medical Products Administration, Center for Certification and Evaluation Center of Jiangsu Medical Products Administration, and China Association for Medical Devices Industry, and representatives from Shanghai MicroPort Medical (Group) Co., Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Micro-Tech (Nanjing) Co., Ltd., Poco International Medical Trade (Shanghai) Co., Ltd., Maquet (Shanghai) Medical Equipment Co., Ltd., Gore Industrial Products Trade (SHANGHAI) Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Siemens Healthineers AG, Becton Dickinson Medical Devices (Shanghai) Co., Ltd., Smith & Nephew Medical (Shanghai) Limited. and Johnson (Shanghai) medical equipment Co., Ltd. The meeting was held online and offline simultaneously, with 20 on-site representatives and 10 online representatives participating at the same time. The meeting was presided over by Yang Xiaofang, the deputy secretary general of CAMDI.
During the meeting, Li Yong, the head of the project group and vice president of Shanghai MicroPort Medical (Group) Co., Ltd. reported on the work carried out since the beginning of the project. By focusing on the significance of the project research, the FDA regulation history, the FDA warning letter system and case analysis, Mr. Li discussed non-conformities and non-conforming clauses/processes issued by FDA in its warning letters in recent years. He also provided suggestions for improving the inspection of medical devices in China.
The experts attending the meeting fully recognized the results of the research project, and put forward comments and suggestions for revision.
Finally, Shi Lei, Deputy Director of the Food and Drug Inspection Center of the National Medical Products Administration, gave a summary of the meeting. Shi pointed out that the purpose of this project is to draw upon the experiences suitable for China’s national conditions through the study of the US FDA warning letter system. The disclosure of government information in China is essentially the same as the warning letter system in the United States, as both are designed to benefit the people. However, they are also a double-edged sword due to the influence of public opinions. We have much to learn from the philosophy and regulatory methods and models of FDA. Meanwhile, the study process is also one in which international exchanges for risks of medical devices are conducted. We also need to explore standards for the boundary between the issuance of warning letters and treating a case as a general issue, and clarify the conditions, time limit, and content of the disclosure of information on unannounced inspection in a more detailed manner. During this project, an in-depth study was conducted on the US FDA warning letter system, the requirements of the project were met, and the expected purpose was achieved. The study results of this project will continue to be used in future supervision practices so as to continuously improve the supervision level.
