From February 9th to 10th, 2023, under the strong support and guidance of the Medical Device Supervision Office of the Fujian Provincial Food and Drug Administration, a special training course on active medical devices hosted by the Fujian Medical Device Industry Association and co-organized by Zhongjian Huatongwei It was successfully held in Fuzhou, Fujian.
The training specially invited Huang Linghong, director of the Medical Device Supervision Division of Fujian Provincial Food and Drug Administration, Ma Renjun of the Provincial Drug Evaluation and Monitoring and Evaluation Center, and Chen Songwang of the Provincial Drug Review and Inspection Center, as well as industry experts to give lectures. CCIC Huatongwei, as a domestic registered inspection expert, was invited to give a lecture on the introduction of the new version of GB 9706.1-2020 series standards and the precautions for EMC inspection of medical device products. More than 160 people, including persons in charge of active medical device production enterprises in the province, management representatives, design and development personnel, regulatory affairs personnel, internal auditors, inspectors, medical device industry supervisors, and representatives of medical device associations in cities and states, participated in the training. The training meeting was presided over by Liang Qingtao, the full-time deputy secretary-general of the Provincial Medical Device Industry Association. Huang Wenbin, deputy general manager of CCIC Huatongwei, made an appearance and participated in the on-site communication.
At the meeting, Director Huang Linghong of the Medical Device Supervision Department of the Provincial Food and Drug Administration emphasized that GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance" and supporting parallel standards and special standards have been issued since April 2020. Released successively, it will be implemented successively from May 1, 2023. This training meeting is to help active medical device manufacturers in Fujian Province learn and master the professional knowledge of the new version of the GB 9706 series of standards, and ensure a smooth transition of the implementation of the new version of the GB9706 series of standards. Enterprises should effectively implement the main responsibility, attach great importance to the implementation of the new GB 9706.1 standard, strengthen the study and training of the new series of standards within the enterprise; seize the opportunity of the implementation of the new GB 9706.1 standard, and ensure that the products produced on the date of implementation of the standard conform to the new version Compulsory standard requirements, speed up the completion of inspection and registration of products related to the new series of standards, and ensure the effective implementation of the new series of standards.
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