In order to thoroughly implement the newly-revised Regulations for the Supervision and Administration of Medical Devices and supporting regulations, further harmonize the medical device industry's understanding of the new regulations and related policies, and practically promote the high-quality and innovative development of the medical device industry, the CAMDI held a special training on the newly-revised Regulations for the Supervision and Administration of Medical Devices and supporting regulations in Beijing from July 29 to 31, 2021.
The relevant leaders of Department of Medical Device Registration and Department of Medical Device Supervision, National Medical Products Administration (NMPA), attended the meeting and interpreted relevant policies. Zhao Yixin, President of CAMDI, attended the meeting and made a speech. The meeting was presided over by Yang Xiaofang, Deputy Secretary General of CAMDI.
President Zhao pointed out that, now it comes at a critical stage when China’s fight against COVID-19 remains stable, the 14th Five-Year Plan has begun and all key work is being carried out continuously. The Regulations for the Supervision and Administration of Medical Devices has been promulgated and implemented for almost two months. The NMPA has revised and released several supporting regulations in a centralized manner to vigorously promote the implementation of the new Regulations. Our member enterprises are expected to systematically study and understand the contents of regulations and comprehensively implement all regulatory requirements through this training.
The pre- and post-market terms in the new Regulations and supporting regulations, medical device production supervision, medical device operation supervision, medical device clinical trial management, the Administrative Measures for Medical Device Registration, the Administrative Measures for IVD Registration, unique device identification (UDI) policies and their implementation and the registrant system were systematically interpreted in detail at the meeting. During the training, representatives studied carefully and asked questions actively, and the lecturing specialists patiently explained common problems patiently and carefully, obtaining good training results.
Finally, Yang Xiaofang, Deputy Secretary General of CAMDI, summarized this training, and expressed sincere thanks to the support and guidance from leaders and experts, leaders’ active participation in the training and wearing masks and keeping a good order throughout the training. According to Yang Xiaofang, CAMDI will continue to response to its members’ demands, build a smoother platform for the scientific supervision of medical devices in China, and carry out targeted high quality training persistently to actively promote industry self-discipline and contribute to the high-quality development of medical devices in China.
The relevant leaders of Department of Medical Device Registration and Department of Medical Device Supervision, National Medical Products Administration (NMPA), attended the meeting and interpreted relevant policies. Zhao Yixin, President of CAMDI, attended the meeting and made a speech. The meeting was presided over by Yang Xiaofang, Deputy Secretary General of CAMDI.
President Zhao pointed out that, now it comes at a critical stage when China’s fight against COVID-19 remains stable, the 14th Five-Year Plan has begun and all key work is being carried out continuously. The Regulations for the Supervision and Administration of Medical Devices has been promulgated and implemented for almost two months. The NMPA has revised and released several supporting regulations in a centralized manner to vigorously promote the implementation of the new Regulations. Our member enterprises are expected to systematically study and understand the contents of regulations and comprehensively implement all regulatory requirements through this training.
The pre- and post-market terms in the new Regulations and supporting regulations, medical device production supervision, medical device operation supervision, medical device clinical trial management, the Administrative Measures for Medical Device Registration, the Administrative Measures for IVD Registration, unique device identification (UDI) policies and their implementation and the registrant system were systematically interpreted in detail at the meeting. During the training, representatives studied carefully and asked questions actively, and the lecturing specialists patiently explained common problems patiently and carefully, obtaining good training results.
Finally, Yang Xiaofang, Deputy Secretary General of CAMDI, summarized this training, and expressed sincere thanks to the support and guidance from leaders and experts, leaders’ active participation in the training and wearing masks and keeping a good order throughout the training. According to Yang Xiaofang, CAMDI will continue to response to its members’ demands, build a smoother platform for the scientific supervision of medical devices in China, and carry out targeted high quality training persistently to actively promote industry self-discipline and contribute to the high-quality development of medical devices in China.