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Conference Background:
- The safety and reliability of medical devices is essential for mankind all over the world. Regulatory authorities in various countries have become more and stricterto manage the risk of medical devices throughout the life cycle. Post-marketing supervision is also an important task for major enterprises. According to the requirements of new laws and regulations in China, the “14th Five-Year Plan” puts forward the requirement of setting registrants as the monitoring subject for the first time, and implements the subject responsibility of enterprises from the division of tasks and working mechanism.
- On October 22, 2021, the Provisions for Self-inspection of Medical Device Registration issued by NMPAis one of the supporting documents for the newly revised Regulations for the Supervision and Administration of Medical Devices. The Provisions allow medical device enterprises to choose between self-inspection or entrusted inspection, which is conducive to accelerating the speed of medical device registration inspection, improving the level of testing ability, compacting the subject responsibility of registrants, stimulating the vitality of industrial innovation and further promoting the high-quality development of the medical device industry.
- The implementation of UDI will pose a profound impact on the quality and safety supervision of all links in the whole life cycle of medical devices. Now, Class III medical devices have been fully promoted and implemented in China. Since May 26, this year, the scope of implementation of UDI in EU regions will be extended to Class IIa and IIb medical devices and Class III-reusable medical devices and Class D in vitro diagnostic reagents. Currently, the implementation of UDI for implantable devices and Class III devices has been completed in the European Union.
Who Should Attend?
- Medical Device Manufacturer: Head of Regulatory, Quality, Compliance, Medical, R & D and Project/Enterprise
- Medical Device Regulatory Consulting, Research and Service Companies
- Medical Device Supervision Authorities and Scientific Research Institutions
*Conference agenda updates according to speaker confirming.
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Yunfeng Chou, Deputy Secretary-General, Committee for Surgical Implants China Association of Medical Device Industry
Anny Fan, Deputy Secretary General, China Surgical Implant Professional Committee
Zikai Hua, Vice Dean, School of Mechatronic Engineering and Automation
Wenbo Jiang, Executive Vice Director, Medical 3D Printing Innovation Research Center，Shanghai Jiaotong University
Vickery Tu, Director of Information Solution Development Center, Guan Cheng, Guan Cheng Information Technology Co., Ltd.
Aiguo Wang, GM, Jiangsu Yisong Medical Technology Co., Ltd.
Eric Liu, General Manager, Suzhou Zhengfeng Micro-Nano Technology Co.,Ltd
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