Introduction: 
The EU and Taiwan are both going through Medical Device Regulation reform. This seminar brings together officials from DG GROW, European Commission, Taiwan Food and Drugs Administration, and the industry representatives to jointly introduce the main changes in both EU and Taiwan regulations, and invites the industry to share its strategy and experience. Attendees will be able to get first-hand information on both EU and Taiwan Medical Device Regulations, and discuss with the honor speakers. The seminar aims to enhance mutual understanding in terms of regulations and practices, further energising bilateral collaborations.
臺灣與歐盟正經歷醫療器材法規翻新，而臺歐在醫療器材經貿活動上，亦有蓬勃發展的潛力。此研討會，邀請來自臺灣及歐盟的產、官代表，介紹臺灣未來新醫療器材法規規劃重點、以及歐盟於2017年發布之最新醫療器材法規 (Medical Device Regulation, MDR; Regulation (EU) 2017/745)及體外診斷醫材法規(In Vitro Diagnostic Medical Device Regulation, IVDR; Regulation (EU) 2017/746) 之主要變革、分享歐盟產業界因應措施。與會來賓，將於研討會中獲悉第一手臺、歐盟最新醫療器材法規內涵，並與講者互動討論。本研討會致力促進臺歐雙邊在醫材管理規範的相互理解、更進一步提升臺歐交流量能。

-Mr Antti Peltomaki, Deputy Director General, DG GROW, European Commission
-Ms Wu Shiou-Mei, Director General, TFDA

Guest speaker: 
-Mr Erik Hansson, Deputy Head of Unit, Health Technology and Cosmetics, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission

-Ms Yueh-Tzu Hung,Technical Specialist, Division of Medical Devices and Cosmetics TFDA
-Ms Yu-Roo Chu, Deputy Director, Division of Medical Devices and Cosmetics TFDA
-Ms Hailey Chu, Scheme Manager & Technical Specialist, BSI Global IVD Team
-Dr  Adelheid Schneider, Regulatory and Quality Manager Asia Pacific, Roche Diagnostics

Organizer: 
DG GROW, European Commission 歐盟執委會成長總署
Taiwan Food and Drugs Administration衛生福利部食品藥物管理署

Co-Organizer: 
Industrial Technology Research Institute 工業技術研究院
European Chamber of Commerce Taiwan 歐洲在臺商務協會

*Free of charge. No lunch meal provided.