2019 APEC醫療器材法規科學卓越中心先期研討會

Workshop Agenda

Time	October 22	October 23	October 24
Morning	Registration	Registration	Registration
	Introduction of Workshop Keynote speech Role of standards in conformity assessment (GHTF/SG1/N44) Role of Standards in the Assessment of Medical Devices (AHWP/WG2-WG8/F002:2014) Introduction on Roadmap and Core-Curriculum of Medical Device PWA Introduction of CoE pilot workshop	Standards Recognition Process Breakout group discussion Group presentations	Case study: How to use the standards in conformity assessment Group presentations Panel discussion (Q&A)
	Coffee Break	Coffee Break	Coffee Break
	Special Section Introduction of medical device registration in each economy Panel discussion (Q&A)	Topic 2: Identify the Challenges in Standards for Regulatory Purposes Keynote speech List of international standards recognized by IMDRF management committee members Improving the quality of international standards for regulatory use Optimizing standard for regulatory use (IMDRF/Standards WG/N51 FINAL:2018)	Expectations from the Workshop and Next Steps Stakeholder presentations Certificate award ceremony
Noon	Lunch	Lunch	Lunch
Afternoon	Topic 1: Understand the Importance of the Use of Standards in the Assessment of Medical Devices Basic scheme of conformity assessment procedure and classification (GHTF/SG1/N77&N78) Summary of essential principles (IMDRF/GRRP WG/N47)	Common Challenges with Registration of Medical Devices Breakout group discussion Group presentations	Manufacturing Site Visit
	Coffee Break	Coffee Break
	Conformity assessment based on the standards Standards Recognition process in Japan ISO/IEC standards recognition process EU standard harmonization process Panel discussion (Q&A)	Topic 3: Optimizing Standards for Regulatory Use Keynote speech How Standards are improved by following IMDRF guidance Case Study: 3rd Party Review based on EP and Standards
Evening	Welcome Reception

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Day 1
Day 2
Day 3

Time	Topic	Speaker
09:00-09:30	Registration
09:30-09:40	Opening Remarks	MOHW: Dr. Shih-Chung Chen Minister, Ministry of Health and Welfare TFDA: Dr. Shou-Mei Wu Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare APEC LSIF RHSC MD PWA Co-Champion: Dr. Yoshimasa Yokoyama Planning and Coordination Officer, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
09:40-09:50	Group Photo
Introduction of Workshop
09:50-10:20	Keynote Speech Role of Standards in the Assessment of Medical Devices (GHTF/SG1/N44 & AHWP/WG2-WG8/F002:2014)	Dr. Matthias Neumann Lead Federal Ministry of Health, Germany
10:20-10:30	Introduction on Roadmap and Core-Curriculum of Medical Device PWA	Dr. Yoshimasa Yokoyama Planning and Coordination Officer, Office of International Cooperation, PMDA, Japan
10:30-10:50	Introduction on Medical Device Management System and the Purpose of the CoE Pilot Workshop	Ms. Cheng-Ning Wu Section Chief, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
10:50-11:00	Coffee Break
Special Section
11:00-12:00	Introduction of Medical Device Registration in Each Economy	Representatives from member economies
12:00-12:20	Panel Discussion (Q&A)
12:20-13:30	Lunch
Topic 1: Understand the Importance of the Use of Standards in the Assessment of Medical Devices Chair: Dr. Chao-Yi Wang Researcher, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
13:30-14:20	Basic Scheme of Conformity Assessment Procedure and Classification (GHTF/SG1/N77&N78)	Mr. Naoki Morooka Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
14:20-15:00	Summary of Essential Principles (IMDRF/GRRP WG/N47)	Dr. Christopher Chan Senior Engineer, Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute
15:00-15:20	Coffee Break
15:20-16:00	Conformity Assessment Based on the Standards Standard Recognition Process in Japan	Mr. Shunsuke Tamaki Technical Officer, Division of Standards for Medical Devices, Office of Standards and Compliance for Medical Device, PMDA, Japan
16:00-16:20	ISO/IEC Standards Developing Process EU standards harmonization process	Dr. Peter Linders Director, Development of Standards and Regulations, Royal Philips, Netherlands
16:20-16:50	Panel Discussion (Q&A)
18:00-20:00	Welcome Reception

Time	Topic	Speaker
Topic 1: Understand the Importance of the Use of Standard in the Assessment of Medical Devices (Cont’d) Chair: TFDA
08:30-09:00	Registration
09:00-09:20	Standards Recognition Process	Dr. Hsiu-Hui Peng Reviewer, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
09:20-09:50	Breakout Group Discussion	Moderator: Ms. Hsin-Hui Lin Section Chief, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
09:50-10:40	Group Presentations and Summary
10:40-11:00	Coffee Break
Topic 2: Identify the Challenges in Standards for Regulatory Purposes Chair: Ms. Shu-Fen Wang Deputy Director, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
11:00-12:00	Keynote Speech List of international standards recognized by IMDRF management committee members (IMDRF report) Improving the quality of international standards for regulatory use (IMDRF report) Optimizing Standard for Regulatory Use (IMDRF/Standards WG/N51 FINAL:2018)	Dr. Matthias Neumann Lead Federal Ministry of Health, Germany
12:00-13:00	Lunch
13:00-13:20	Common Challenges with Registration of Medical Devices	Dr. Cheng-Wen Lan Senior Reviewer, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
13:20-14:20	Breakout Group Discussion	Moderator: Ms. Shu-Fen Wang Deputy Director, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
14:20-15:10	Group Presentations and Summary
15:10-15:30	Coffee break
Topic 3: Optimizing Standards for Regulatory Use Chair: Mr. Naoki Morooka Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
15:30-15:50	Keynote Speech How standards are improved by following IMDRF guidance - perspectives from Regulator SDO	Regulator: Dr. Matthias Neumann Lead Federal Ministry of Health, Germany SDO: Dr. Peter Linders Director, Development of Standards and Regulations, Royal Philips, Netherlands
15:50-16:50	Case Study: 3^rd Party Review based on EP and Standard	Mr. Eiji Oshida Senior Expert, Medical Products, TUV Rheinland Japan Ltd., Japan

Time	Topic	Speaker
Topic 3: Optimizing Standards for Regulatory Use (Cont'd) Chair: Mr. Naoki Morooka Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
08:30-09:00	Registration
09:00-09:50	Case Study: How to Use the Standards in Conformity Assessment glucose monitoring system and electric sphygmomanometer	Moderator: Mr. Chih-Ping Hung Senior Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
09:50-10:30	Group Presentations and Summary
10:30-10:50	Panel Discussion (Q&A)
10:50-11:10	Coffee Break
Expectations from the Workshop and Next Steps
11:10-11:35	Expectations from the Workshop and Next Steps Regulator (5 mins) APEC LSIF RHSC MD PWA Co-Champion (5 mins) APEC LSIF RHSC MD PWA Sub-Champions (5 mins each) IMDRF Standards WG (5 mins) SDO (5 mins)	Dr. Chao-Yi Wang Researcher, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare Dr. Yoshimasa Yokoyama Planning and Coordination Officer, Office of International Cooperation, Japan Mr. Naoki Morooka Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan Dr. Matthias Neumann Lead at Federal Ministry of Health, Germany Dr. Peter Linders Director, Development of Standards and Regulations, Royal Philips, Netherlands
11:35-12:00	Certificate Award Ceremony	Ms. Pei-Weng Tu Director, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
12:00-12:05	Group Photo
12:05-12:10	Closing Remark	Ms. Pei-Weng Tu Director, Division of Medical Devices and Cosmetics, TFDA, Ministry of Health and Welfare
12:10-13:10	Lunch
13:10-17:00	Manufacturing Site Visit
	Adjourn