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	Experience Sharing on FDA Certification Related Problems and the Countermeasures Beijing Tonghe Litai Biotechnology Co.Ltd. (proposed)
10:30-11:00	MDR Policy and its Impact on Manufacturing of Enterprises Tianjin Haihe (proposed)
11:00-11:30	Fast Track for Medical Device Listing: Clinical Evaluation Strategy Planning and Practice LINKS CRO (proposed)
11:30-12:00	Case Sharing – Overseas Declaration and Registration Strategy for Innovative Medical Devices XINNUO (proposed)
12:00-13:30	Lunch & Exhibition
13:30-13:40	Moderator Remarks
13:40-14:25	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
14:25-15:10	Requirements for Review of Plant Interventional Materials Wuxi AppTec
15:10-15:30	Major Challenges in the Biocompatibility Evaluation of Drug-Device Combination Products Biao Xu, Technical Director of Biocompatibility Laboratory, WuXi AppTec Medical Device Testing Center
15:30-15:50	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
15:50-16:10	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
16:10-16:30	Evaluation of Antimicrobial Performance of Drug-Device Combination Products Mengxing He, Head of Microbiology Laboratory, WuXi AppTec Medical Device Testing Center
16:30-16:40	Conference Close
*The agenda may be subject to changes due to adjustment of confirmed speakers
speakers
Beijing Tonghe Litai Biotechnology Co.Ltd. (proposed) Tianjin Haihe (proposed) LINKS CRO (proposed) XINNUO (proposed) Lane JI Medical Device Quality System and Regulations Expert, Chief Regulatory Counselor of Tengyun Medical Wuxi AppTec 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
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The 5th Edition of Regulatory Lecture: Practice for Product Compliance and Market Launch

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