According to the work arrangements of the National Medical Products Administration (“NMPA”), the 10-day online training in the new GB 9706.1 standards hosted by the Center for Medical Device Standardization Administration (“CMDSA”) and co-hosted by related medical device standardization technical committees was successfully concluded on October 28, 2022. According to statistics, more than 46,000 entities and more than 206,000 people from 31 provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps participated in the training. The training objects covered different levels of medical device regulatory authorities, medical device inspection institutions within and outside the drug regulatory system, medical device registrants (filing parties) and overseas medical device agents.
Experts who have been long engaging on the front line of medical electrical equipment inspection and testing and production R&D were selected in this training to give in-depth interpretations of the 59 new GB 9706.1 standards already issued and comprehensively explain the specific content of each standard, including the analysis of the scope of application, the explanation of specific technical indicators and a focus on the main technical differences between the old and new versions of the standards. To make participating trainees better understand the content of the standards, some lecturers added an interactive Q&A session to extensively collect questions raised by the participating trainees and actively respond to and answer them, which further improved the effectiveness of the training.
This training fully reflected the prominent characteristics of “rich content, wide coverage, large amounts of information and strong guidance”, satisfied the expected goals, further unified related parties’ understanding of the new GB 9706.1 standards and laid a solid foundation for promoting the smooth implementation of the new GB 9706.1 standards.
To facilitate the entities and individuals to continue to learn the standards, all the training videos of this training are provided for playback. The “Online Class for Interpretation of New GB 9706.1 Standards” column has also been set up on the CMDSA website. The training video courseware of the 59 new GB 9706.1 standards already issued has now been available (courseware link: https://www.nifdc.org.cn/nifdc/zt/bzjd/bzjdsp/index.html) for related sides to receive long-term online free training in the standards. The CMDSA will timely organize related training in new GB 9706.1 standards subsequently issued.
Links for playing back the videos of this training (valid for 30 days from the date of training):
October 17: https://meeting.tencent.com/l/wsHIc6dfRIxD
October 18: https://meeting.tencent.com/l/TInmHwqz4l8X
October 19: https://meeting.tencent.com/l/4aXccN2N5YaE
October 20: https://meeting.tencent.com/l/RERk8PUhoJaL
October 21: https://meeting.tencent.com/l/Zfl8Qo5wFKMV
October 24: https://meeting.tencent.com/l/di5Ye2Wp5O1l
October 25: https://meeting.tencent.com/l/0p5s864ZQDum
October 26: https://meeting.tencent.com/l/5CYheIVOj1Dt
October 27: https://meeting.tencent.com/l/TkAqFd84MQzn
October 28: https://meeting.tencent.com/l/lx5XAeyLacKt
Source: National Institutes for Food and Drug Control
Experts who have been long engaging on the front line of medical electrical equipment inspection and testing and production R&D were selected in this training to give in-depth interpretations of the 59 new GB 9706.1 standards already issued and comprehensively explain the specific content of each standard, including the analysis of the scope of application, the explanation of specific technical indicators and a focus on the main technical differences between the old and new versions of the standards. To make participating trainees better understand the content of the standards, some lecturers added an interactive Q&A session to extensively collect questions raised by the participating trainees and actively respond to and answer them, which further improved the effectiveness of the training.
This training fully reflected the prominent characteristics of “rich content, wide coverage, large amounts of information and strong guidance”, satisfied the expected goals, further unified related parties’ understanding of the new GB 9706.1 standards and laid a solid foundation for promoting the smooth implementation of the new GB 9706.1 standards.
To facilitate the entities and individuals to continue to learn the standards, all the training videos of this training are provided for playback. The “Online Class for Interpretation of New GB 9706.1 Standards” column has also been set up on the CMDSA website. The training video courseware of the 59 new GB 9706.1 standards already issued has now been available (courseware link: https://www.nifdc.org.cn/nifdc/zt/bzjd/bzjdsp/index.html) for related sides to receive long-term online free training in the standards. The CMDSA will timely organize related training in new GB 9706.1 standards subsequently issued.
Links for playing back the videos of this training (valid for 30 days from the date of training):
October 17: https://meeting.tencent.com/l/wsHIc6dfRIxD
October 18: https://meeting.tencent.com/l/TInmHwqz4l8X
October 19: https://meeting.tencent.com/l/4aXccN2N5YaE
October 20: https://meeting.tencent.com/l/RERk8PUhoJaL
October 21: https://meeting.tencent.com/l/Zfl8Qo5wFKMV
October 24: https://meeting.tencent.com/l/di5Ye2Wp5O1l
October 25: https://meeting.tencent.com/l/0p5s864ZQDum
October 26: https://meeting.tencent.com/l/5CYheIVOj1Dt
October 27: https://meeting.tencent.com/l/TkAqFd84MQzn
October 28: https://meeting.tencent.com/l/lx5XAeyLacKt
Source: National Institutes for Food and Drug Control