Industry big coffees gathered in Zhuhai and discussed the development of medical weapon compliance

On August 31, the special exchange sharing of medical device co -management management was successfully held at the acceleration base of the Guangdong Medical Valley • Zhuhai Medical Industry. Huawei, deputy director of the High -tech Zone Science and Technology Innovation and Industrial Development Bureau, Xie Jiasheng, executive president of Guangdong Medical Valley and many representatives from government, investment, media, industry associations and consulting services, and representatives of biotechnology companies to visit the event site.

It is understood that this event is the first industrial exchange meeting after Guangdong Medical Valley • Zhuhai Medical Industry Acceleration Base entered the operation acceleration stage. It aims to create a professional and relaxed communication platform for Zhuhai biomedical industry to promote the integration of the biomedical industry. develop.

Huawei, deputy director of the High -tech Zone Science and Technology Innovation and Industrial Development Bureau, pointed out in his speech that at present, there are more than 100 biomedical and medical device companies in the high -tech zone. There are 3 output value of biomedical and medical device companies in the region, and 10 of more than 100 million yuan. In the first half of this year, the regional biomedical and medical device industry realized the industrial output value of 3.23 billion yuan, an increase of 37.6%year -on -year, and maintained more than 20%in seven consecutive quarters.

Huawei, deputy director of the High -tech Zone Science and Technology Innovation and Industrial Development Bureau

Xie Jiasheng, executive president of Guangdong Medical Valley, mentioned in his speech that Guangdong Medical Valley deeply cultivated the Greater Bay Area and looked forward to layout cities in Bay Area in Guangzhou, Zhuhai, Foshan. Zhuhai's biomedical industry has a relatively deep foundation and is one of the important layouts of Guangdong Medical Valley. Over the years of precipitation, the biomedical industry cluster of Guangdong Medical Valley has been growing, and medical device companies in Guangdong Medical Valley Park have also occupied a very important part. To do a good job of compliance management of medical devices and avoid regulatory risks, it is one of the important work of everyone.

Xie Jiasheng, executive president of Guangdong Medical Valley

Shao Jia, deputy secretary -general of the Zhuhai Medical Device Industry Association, pointed out that medical device companies can only implement the operation and develop in the long -term development only in accordance with the "compliance" standards. To improve the awareness of the main responsibility of each enterprise, at the same time, we need to work together to deepen the communication and connection between various companies.

Shao Jia, Deputy Secretary -General of Zhuhai Medical Device Industry Association

Director Xiao Ge Fei of the Genetics Laboratory of Zhuhai Maternal and Child Health Hospital details the process specifications of the clinical trials of the Zhuhai Maternal and Child Health Hospital, the core issues of scientific science and the protection of the safety rights and interests of the subject, and the daily management and filing of clinical trial institutions The inspection and other situations were shared.

Director Xiao Ge Fei, the Genetics Laboratory of the Maternal and Child Health Hospital of Zhuhai City

Teacher Liang Zijing, a senior expert consultant of Guangdong Medical Device Research Institute, shared the "Medical Aesthetic/Injection Medical Device NMPA Registration Raiders" on the spot. He said that many medical device products are widely used in the medical beauty industry. This time, the main aspects of the second category of medical beauty equipment and the review point of review and the compliance of medical beauty equipment are interpreted in detail.

Teacher Liang Zijing, senior expert consultant of Guangdong Medical Device Research Institute

Dr. Cold Steel, the founder and CEO of Youwei Bio, proposed in the theme sharing that soluble micro -needles are used as the latest generation of transparent dosing technology. Excellent balance, has broad application prospects in the field of skin care, medical beauty and medicine. It shared the content of the soluble microne acupuncture and its efficacy certification.

Dr. Cold Steel, the founder and CEO of Youwei Bio,

GB 9706.1 is a basic standard for medical devices, and all medical electrical equipment must meet the standard requirements. The China Inspection Hua Tongwei Xu Chengcai interpreted the new version of the medical electrical safety GB9706.1-2020 standard for everyone. He pointed out that compared with the old version, the standard name and overall structure have changed greatly compared with the old version. It not only emphasizes the importance of risk management, but also puts forward higher technical requirements for the protection and safety of equipment and basic performance. This is a new challenge for domestic regulators, manufacturers, inspection agencies, and users.

China Inspection Hua Tongwei Xu Chengcai

Participants have said that the sharing and exchanges of the speaker have given everyone a deeper understanding of medical weapon compliance. At the same time, this exchange meeting will be used as an opportunity to strengthen learning and in -depth thinking, and better deploy all the work of medical skills compliance.

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