The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch

The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch September 26, 2024 \| Meeting Room B, Hall 1, Shanghai World Expo Exhibition & Convention Center, Shanghai, China Co-organizers：Medtec China
Introduction：
Conference Background Medical devices are directly applied for the human body, their quality and safety are directly related to people’s health and safety. Governments of various countries ensure the quality, safety and efficacy of medical devices by establishing and enforcing medical device laws and regulations and implementing well-organized rigorous registration and marketing procedures, thus protecting health of the people. At the same time, it is also crucial for companies to produce compliant medical devices under the guidance of regulations to improve their core competitiveness. Purpose: Discuss the key regulations and response strategies in the medical device industry Seek ways to accelerate the medical device products launch. Jointly promote the innovation and development of medical device products Combine with the concurrent exhibitions to provide a platform for medical device regulatory practitioners to communicate and interact with each other Participants: Medical device manufacturers: heads of the departments of registration, quality, compliance, medical, and R&D, as well as project/company leaders Domestic and international providers engaged in medical device regulatory consulting, testing, certification, inspection, clinical trials, etc. Medical device regulatory agencies and research organizations
Agenda：
Time	Agenda
9:50-10:00	Moderator Remarks
10:00-10:30	Requirements for Animal Testing in Medical Device Registration Application Yingjun Li, GM, Beijing Tonghe Litai Biotechnology Co., Ltd.
10:30-11:00	Medical Device Clinical Evaluation: Scientific Strategic Planning and Successful Case Analysis Ivy Huang, Senior CER Manager, LINKS Medical Scientific (Shanghai) Co., Ltd.
11:00-13:30	Lunch & Exhibition
13:30-13:40	Moderator Remarks
13:40-14:25	Research and Reflection on the Design and Development of Medical Devices Combining Drugs and Devices Monica Zhou, RD Director, JWMS
14:25-14:45	Major Challenges in the Biocompatibility Evaluation of Drug-Device Combination Products Biao Xu, Technical Director of Biocompatibility Laboratory, WuXi AppTec Medical Device Testing Center
14:45-15:05	Technical Key-points and Case Studies Sharing on Chemical Characterization and Toxicological Risk Assessment of Drug-Device Combination Products Xiaolong Rong, Technical Director of Chemical Laboratory, WuXi AppTec Medical Device Testing Center
15:05-15:25	Analysis of Key Considerations in Preclinical Animal Research for Drug-Device Combination Products Changhao Jia, Technical Director of Surgical Services, WuXi AppTec Medical Device Testing Center
15:25-15:45	Evaluation of Antimicrobial Performance of Drug-Device Combination Products Mengxing He, Head of Microbiology Laboratory, WuXi AppTec Medical Device Testing Center
15:45-16:30	Discussion on Common Issues in the Design and Clinical Review of EU MDR Certification Lane JI, Medical Device Quality System and Regulations Expert, Chief Regulatory Counselor of Tengyun Medical
16:30-16:40	Conference Close
*The agenda may be subject to changes due to adjustment of confirmed speakers
speakers
Yingjun Li GM, Beijing Tonghe Litai Biotechnology Co., Ltd. Ivy Huang Senior CER Manager, LINKS Medical Scientific (Shanghai) Co., Ltd. Monica Zhou RD Director, JWMS Biao Xu Technical Director of Biocompatibility Laboratory, WuXi AppTec Medical Device Testing Center Xiaolong Rong Technical Director of Chemical Laboratory, WuXi AppTec Medical Device Testing Center Changhao Jia Technical Director of Surgical Services, WuXi AppTec Medical Device Testing Center Mengxing He Head of Microbiology Laboratory, WuXi AppTec Medical Device Testing Center Lane JI Medical Device Quality System and Regulations Expert, Chief Regulatory Counselor of Tengyun Medical
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The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch

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