On July 18-19, 2017, the National Center for Adverse Drug Reaction Monitoring Symposium 2017 for Directors was held in Weihai, Shandong. The symposium was firstly themed at medical device adverse events monitoring and re-evaluation, held by the China Food and Drug Administration (CFDA) Center for Drug Reevaluation (CDR) (the National Center for Adverse Drug Reaction Monitoring). Jiao Hong, the deputy director of China Food and Drug Administration (CFDA), attended the meeting and made a speech.
Jiao Hong affirmed their achievements in the medical device adverse events monitoring network construction and the effect of adverse events monitoring and re-evaluation during the “12th Five-Year Plan”. As one of the important post-market supervision means, the medical device adverse event monitoring is playing an increasingly role in discovering, studying and controlling risks. With the continuous advancing of the 13th Five Year Plan, we should pay further attention to medical device adverse event monitoring and give full play to the combined mechanism of inspection, monitoring, and selective acceptance to improve the post-market medical device supervision capability. The CFDA will improve the medical device AE and re-evaluation laws and regulations system, intensify the responsibility of medical devices manufacturers as the reporting entity and strengthen propaganda and training to improve the understanding of medical devices manufacturers in medical device AE monitoring and further play the role of medical institutions. The monitoring authorities of all levels should actively study the policies with an international perspective and promote the medical device AE monitoring.
The representatives from Beijing, Jiangsu, Shandong, and Shenzhen AE monitoring centers shared their experience and measures in medical device AE monitoring and re-evaluation. Kong Fanbu, director of Department of Medical Device Supervision of CFDA, presented the following medical device AE monitoring and re-evaluation arrangement. Over 60 representatives from the Department of Medical Device Supervision of CFDA, National Center for Adverse Drug Reaction Monitoring, Shandong FDA, Weihai government principals and provincial drug AE monitoring centers and some prefecture-level drug AE monitoring centers attended the meeting. The meeting was presided over by Yang Wei, the director of Center for Drug Reevaluation of CFDA.