Efforts to enhance the quality and safety of the entire chain of medical devices! This initiative in Hebei has received widespread acclaim!
Release time:
2023-07-21
【SUMMARY】 In order to deepen the exchange of experiences in the quality and safety management of medical devices, promote the regulatory policies for medical devices, further standardize the production, operation, and use of medical devices, enhance the professional skills and regulatory capabilities of regulatory personnel, and promote the healthy development of the medical device industry, the "Quality and Safety Experience Exchange and Regulatory Law Promotion Activity for the Production, Operation, and Use of Medical Devices" was successfully held at the Provincial Senior University, organized by the Hebei Provincial Drug Supervision Administration and hosted by the Hebei Provincial Medical Device Industry Association, according to the activity arrangement for the 2023 Provincial Medical Device Safety Promotion Week.
To deepen the exchange of experiences in the quality and safety management of medical devices, promote the regulatory policies for medical devices, further standardize the production, operation, and use of medical devices, enhance the professional level and regulatory capabilities of regulatory personnel, and promote the healthy development of the medical device industry, according to the activity arrangement of the 2023 provincial medical device safety publicity week,Recently, the "Quality Safety Experience Exchange and Regulatory Law Promotion Activity for Medical Device Production, Operation, and Use" hosted by the Hebei Provincial Drug Supervision Administration and organized by the Hebei Provincial Medical Device Industry Association was successfully held at the Provincial Senior University.
Wang Fengshan, Deputy Director of the Hebei Provincial Drug Supervision Administration, attended the event and delivered a speech. Zhang Shuxing, Director of the Medical Device Supervision Department of the Provincial Drug Supervision Administration, and Fan Yu, a first-level researcher of the Medical Device Registration Department, participated in this event, and Liu Shengjun, President of the Provincial Medical Device Industry Association, hosted the event.
In his speech, Deputy Director Wang Fengshan pointed out,With the continuous development of medical technology, the types of medical devices are increasing, and their application range is becoming more extensive. Medical devices have entered thousands of households, and the safety of using these devices has become a matter of life and health for everyone. The safety of medical devices is related to people's well-being, economic development, social harmony, and national image. Ensuring the quality and safety of medical devices and industrial development relies on the joint efforts and support of all sectors of society.
Wang Fengshan emphasized that implementing the main responsibility of enterprises is a rigid requirement of laws and regulations, and it is also an inevitable requirement for the development of enterprises themselves. All medical device production and operation enterprises and user units must earnestly study the "Regulations on the Supervision and Administration of Medical Devices" and the "Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for Medical Device Quality and Safety," and effectively assume the main responsibility for product quality and safety, ensuring that the entire process of production, operation, and use is legal and compliant.
Deputy Director Wang Fengshan also introduced a series of measures taken by the Provincial Drug Supervision Administration to innovate regulatory services, optimize approval processes, reduce the burden on enterprises, and improve approval efficiency.
At the meeting, Zhang Shuxing, Director of the Medical Device Supervision Department of the Provincial Drug Supervision Administration, promoted and interpreted the medical device regulatory laws. First-level researcher Fan Yu provided guidance on the management of the medical device quality management system. Guo Yan, head of the Medical Device Section of the Xingtai Market Supervision Bureau, shared experiences in improving the quality of medical devices. Representatives from five medical device production enterprises, three medical device operation enterprises, three medical institutions, and one medical device user enterprise introduced their experiences in quality and safety management in the production, operation, and use of medical devices.
This event promoted the medical device regulatory laws, exchanged experiences in the quality and safety management of medical device production, operation, and use, further enhanced the professional level of regulatory personnel, and laid a foundation for strengthening the regulatory efforts on medical devices and severely cracking down on various illegal activities related to medical devices. It also helped enterprises learn the legal provisions, understand the governance spirit, and further enhance the awareness of corporate main responsibility, receiving widespread recognition and praise from participating enterprises.
In the next step, the Provincial Drug Supervision Administration will focus on implementing the main responsibility for the quality and safety of medical devices, vigorously improve the quality management level of medical devices in the province, and fully ensure the health and safety of the people.
This article is from
Yao An Shi Mei Cheng Xin He Bei
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