Medical Device Registration, Verification and Adverse Events Monitoring Forum 08:30-12:00, September 12 Co-Chair: Jia Jianxiong Comprehensive Business Division, Center for Medical Device Evaluation, CFDA.

Co-Chair: Priya Jagasia Director, Regulatory Affairs of Abbott Vascular. She has extensive experience inregulatory affairs for both drugs and devices. She has managed the regulatory strategy for multipledevice applications for both DES and BVS applications in US, Canada and other geographies. Mostrecently, she was part of the BVS panel prep team in the US. She is also part of the AdvaMedworking group for combination products. Priya holds a Master's degree in Analytical Chemistry fromMississippi State University in the US.

08:30-08:35 Introduction of Co-Chairs

08:35-09:15 Introduction of Verificaiton Procedure for Demestic Class III Medical Devices Registration System and Common Questions Jia Jianxiong, Comprehensive Business Division, Center for Medical Device Evaluation, CFDA.

09:15-09:45 QMS: Difference between US Device Regulations and China GMP Randy Mckay, Vice President of Regulatory Operations for Becton Dickinson. He has over 25 years of experience in the medical device, pharmaceutical, and diagnostics industry. Randy has been with Becton Dickinson and Company (BD) for eighteen years and has held various leadership positions in Quality Management and Regulatory Operations and Compliance and General Management. Prior to joining BD, Mr. McKay worked at Ortho-Clinical Diagnostics, a Johnson & Johnson Company, and held various positions in Engineering and Quality Management. Mr. McKay received his MS degree in Engineering Management in 1991 and a BS degree in Industrial Engineering in 1986, both from New Jersey Institute of Technology. Mr. McKay is also an ASQ Certified Quality Engineer.

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09:45-10:15 Explanation of the New Version of ISO 13485:2016 Lian Hongwen, Senior Manager of Medical and Health Service in North Region, TÜV (Technischen Uberwachungs-Vereine) Nande Service of Testing (China) Co., Ltd. and ISO9001 and ISO13485 registered senior auditor. She is also medical device senior auditor and product expert of Europe Notified Body. Besides, she is Japanese J-GMP/J-QMS senior auditor and in charge of medical device quality system certification and evaluation of UN medical device CE product certification. She has engaged in quality standard management, production license and technical evaluation of medical devices for 13 years. She worked at Standard Department of Quality Department, State Pharmaceutical Administration, took charge of organizing the revision of national standards and industrial standards of medical devices, and participated in coordination of secretariat in China of ISO/TC76, TC84, TC106, TC121, TC157, TC170 and IEC/TC62.LianHongwen also worked at Supervision Department of Medical Device Department, State Pharmaceutical Administration, took charge of medical device product certification and production license. Moreover, she served in Center for Medical Device Evaluation, State Pharmaceutical Administration of China, and took charge of registration and evaluation of ClassⅢmedical device products in China.

10:15-10:30 Tea Break

10:30-11:00 Quality Management System Audits Experiences Sharing and Case Study Xu Defang, GEHC China and APAC Region QA Director, ASQ Certified Quality Auditor, Certified Software Quality Assurance Engineer. Have worked as electrical engineer, Quality Assurance Leader, Senior Auditor etc. Being involved in Quality Management System setup and maintenance. Audited more than twenty manufacturing sites in US, German, Japan, China etc. under GEHC. Now lead a quality team to maintain, promote and train the quality management system in China and APAC. Coordinate the internal and external audits. Achieve the quality goals and improve the quality management system. Report to China and US management team the quality system performance and improvement opportunities. Have worked in Medical Device Quality System Area for more than 12 years in GEHC now. Be familiar to US FDA, China CFDA, Europe MDD etc. medical device regulations. Trained the first CFDA inspectors about Quality System Audit Knowledge as Active Medical Device trainer in 2015.

11:00-11:30 Medical Device Single Audit Program(MDSAP) - One Audit for Multiple Market Access Sicong Yu, Lead Auditor of Medical-Health-Service of TÜV SÜD Certification and Testing (China) Co., Ltd. A lead auditor of Europe Notified Body, holding responsibility for medical device quality system certification, CE product certification, J-QMS, CMDCAS, MDSAP audit. He once worked in Device registration department, Shanghai FDA. Besides, he was once worked in CMTC, Shanghai Certification center and Shanghai FDA hongkou branch.

11:30-12:00 The Risk Control of Production Quality Management System for Medical Device Wan Xi, System Director of Jyton Group.

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13:30-18:00, September 12 Co-Chair: Guo Zhun Center for Food and Drug Inspection of CFDA.

Co-Chair: Xu Defang GEHC China and APAC Region QA Director, ASQ Certified Quality Auditor, Certified Software Quality Assurance Engineer. Have worked as electrical engineer, Quality Assurance Leader, Senior Auditor etc. Being involved in Quality Management System setup and maintenance. Audited more than twenty manufacturing sites in US, German, Japan, China etc. under GEHC. Now lead a quality team to maintain, promote and train the quality management system in China and APAC. Coordinate the internal and external audits. Achieve the quality goals and improve the quality management system. Report to China and US management team the quality system performance and improvement opportunities. Have worked in Medical Device Quality System Area for more than 12 years in GEHC now. Be familiar to US FDA, China CFDA, Europe MDD etc. medical device regulations. Trained the first CFDA inspectors about Quality System Audit Knowledge as Active Medical Device trainer in 2015.

13:30-13:35 Introduction of Co-Chairs

13:35-14:15 Medical Device Quality System Requirements And Inspect Problem Analysis Guo Zhun, Center for Food and Drug Inspection of CFDA.

14:15-14:45 ISO 9001:2015 Changes - Summary of the Changes Introduced in ISO 9001:2015 Matt Safi, the Managing Director of Pharma Bio Solutions Ltd with offices in England and China. He has over 35 years' experience in Pharmaceutical industry. Pharma Bio Solutions provide Automation solutions (MES, LIMS, QMS, WMS, DCS, SCADA &PLC, DDC, EMS, etc.) to the pharmaceutical industry based on GAMP5. It also offers Engineering and validation consultancy services. Matt has worked on Automation Control System and Data Management System projects in Europe, USA, China, Korea, India, Brazil, Mexico, etc. He has extensive experience using GAMP techniques over the full range of projects from small data monitoring systems through to large DCS & MES, QMS, LIMS, WMS systems, and embedded control systems for complex machines.

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14:45-15:15 CADe Software Devices Regulatory Registration Requirement Comparison between FDA and CFDA Qin Chuan, GE Healthcare Regulatory Affairs Manager. Be responsible for Imaging software registration and the collection, analysis of new regulation. Once served at Siemens, Motorola as application software engineer, product manager, quality assurance manager. Software quality engineering by ASQ, Project Management Professional by PMI Got a Master degree from Shanghai Jiao tong University Biomedical engineering.

15:15-15:45 Risk Management for IT-networks Incorporating Medical Devices - The Introduction for IEC 80001-1 Macro Wu, Standardization Counsel works for Intellectual Property & Standards China Philips (China) Investment Co., Ltd. Engaged in study of regulations and standards which are relevant to medical devices.

15:45-16:00 Tea Break

16:00-16:30 Principles of Total Product Lifecycle Risk Management Kimberly Oleson, Global Vice President of Clinical Affairs for Danaher Corporation. She brings 30 years of visible achievements in the medical device industry related to clinical affairs, preclinical research, quality systems and regulatory affairs. Prior to joining Danaher Corporation, she enjoyed a 28-year tenure at Medtronic Inc. where she was the strategist responsible for building the company's first centralized clinical operations organization serving the company's broad portfolio of clinical trials. She has patented risk management methods related to the total product lifecycle and clinical trials, and she was recognized with the company's highest award for distinguished service. Trained as a biostatistician, Ms. Oleson's career includes positions of increasing responsibility across large, venture-based and newly-acquired businesses, resulting in health care advances through the introduction of novel medical technologies in the fields of cardiology, neurology,urology, gastroenterology and drug delivery. In addition to her clinical trial expertise, she is an industry representative for various committees including the International Standards Organization which published the ISO 14155:2011 Good Clinical Practice standard for medical device clinical trials and the AdvaMed Clinical Trials Working Group. Kimberly holds a B.A. degree in Biometry from the University of Minnesota.

16:30-17:00 The Mechanism of Adverse Event Monitoring and Data Analysis for Product Improvement Tong(Patrick) Wang, GE Healthcare post market regulatory affairs leader. He has been worked in medical device industry for 10 years. He started his career from R&D, then engaged in clinical research, and now works in post market regulatory affairs & mainly focused on adverse event & recall. Besides his extensive experiences with China post market regulations, he also activates as a key member of GE global post market regulatory affairs CoE team (Center of Excellence), which mostly focused on the internal effectiveness review on the company’s regulatory compliance & the improvement on current quality management system from global level, therefore he possesses good understanding of global requirements as well.

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17:00-17:30 Current 510(K) Clinical Regulation Update: Tracking on SAEs & AEs in Medical Device Study Joalin Lim, MS, PhD,CCRP. Managing Director, Agape-Life System Support Pte Ltd (Singapore). Joalin has over 20 years of experience in clinical, regulatory, and reimbursement affairs globally. Most recently, she was the Managing Director of Clinlogix (consultant), Head of Operations at Quintiles (Asia Pacific) and was responsible for strategy, operations, and business development. Previously, she was the Vice-President of Regulatory, Reimbursement, and Clinical Affairs at Agape Life System Support (Singapore-USA), a medical device consulting company. She has worked in clinical and regulatory affairs departments with several companies including Covidien (as Director of Clinical Affairs for Asia Pacific), Abbott, Hill-Rom, Medtronic, Boston Scientific, and Harvard Medical School. 17:30-18:00 Medical Device Adverse Events Monitoring and Security Reevaluation Guan Wei, Medical Device Management Institute, Center for Drug Reevaluation, CFDA. From 2004 to 2010, she studiedbiochemistry and molecular biology in Academy of Military Medical Sciences for herdoctoral degree and worked there. From 2011 to 2014, she worked at Beijing Center for Adverse Drug Reaction Monitoring. Since 2014, she works atNationalCenter for Adverse Drug Reaction Monitoringto engage in the monitoring and evaluation of adverse events of medical devices.She is mainly in charge of some monitoring and evaluation work of passivemedical devices. She participated inthe study on key monitoring modelof orthopaedic implants and pilot workof revaluationof chitosan medical device products, and wrote research reports. She also participated in the formulation of measures and regulations related to medical devices. She has relevant experience in monitoring and revaluation of adverse events formedical devices.

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