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Conference on EU-Taiwan Medical Device Regulation 臺歐盟醫療器材法規研討會
Wednesday, 6 June 2018, 09:00 - 16:40

[Fully booked] Conference on EU-Taiwan Medical Device Regulation 

Time: 6 June 2018, 09:00-16:40
Venue: CPC Building, Taipei 中油大樓 國光廳 (台北市信義區松仁路三號)


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。

Guest of honor: 
-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
 Adelheid Schneider, Regulatory and Quality Manager Asia Pacific, Roche Diagnostics
-Mr Paul Swift, Director Global RA Project IOL, Alcon
Mr Heinrich Martens, Director Regulatory Affairs & QA - Application Devices Disposable (Medical Device), Fresenius Kabi
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

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.

 - Please Note-
The event registration is only available via here.
Two registrations per company 
For more details, please contact Huang Yu-Lun / Tel 2740-0236 ext. 228 / huang.yulun@ecct.com.tw / www.ecct.com.tw

  Location: Int’l Conference Room, 1F., CPC Headquarters Building
No.3, Songren Rd., Sinyi District, Taipei City
中油國光會議廳 (台北市信義區松仁路3號 中油總部大樓一樓)
  Registration Deadline: Tuesday, 5 June 2018, 12:00
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