The European Chamber is pleased to invite you to the next Healthcare Equipment Working Group meeting. It will be held on Wednesday, 26 March, 3pm-6pm, at the European Chamber Beijing and Shanghai offices via videoconference.
Opening -the Co-Chairs and Vice Chairs will summarize the Working Group activities in year 2013.
Continue with the working plan presentations for year 2014. All champions for the 9 topics that members discussed and identified as priorities of the Working Group of the year, will present.
Priorities
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Champion
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the Medical Devices Regulations Measures (Revised Draft) (what we call “Order 276”) and sub-regulations
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Carol YAN, JNJ, Tracey GAO, Siemens, and Jessica YUAN, EUCCC
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Clinical Trial Requirements and Classification of medical devices
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Amber WANG, Smith &Nephew
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EMC
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SUN Zhuohui, GE
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Medical Software
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Daniel CHEN, Philips
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Re-registration
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Victoria QU, JNJ
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Post –Market Surveillance
· Re-processing of single use products
· Medical equipment in use
· GMP
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Champions:
Victoria QU,JNJ
HAN Bajin,GE
Tracey GAO, Siemens
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IVD
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Gina WANG, Abbott
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Tendering
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Rosely LIU, Smith & Nephew
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Guidance on Pricing medical service items
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Rosely LIU, Smith & Nephew and TIAN Jiang, JNJ
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Additionally, we will hold 2014-2015 Chair elections. The Healthcare Equipment Working Group Co-Chairs and Vice Chairs play a crucial role in driving the Working Group, which includes a leadership role in the drafting of the Position Paper, communicating key messages to Chinese and European government authorities and steering Working Group meetings. The desired characteristics of Co-Chairs and Vice Chairs are a senior industry representative with relevant industry expertise and government contacts who has the time and willingness to support the Working Group. Previous participation in the Working Group is essential. The maximum duration of Chairmanship or Vice Chairmanship of a Group is three consecutive years. Candidates are only eligible for Chair or Vice Chair position if he/she is physically based in China and it is recommended that the member holds the position in the Chapter where he/she is physically based. Only Corporate members of the Chamber are eligible for Chair positions unless specific approval has been obtained from the Chamber’s Executive Committee. Both Corporate and Associate members are eligible to hold Vice Chair positions. For the Healthcare Equipment Working Group, it is possible to have at most two Co-Chairs and two Vice Chairs.
Should you be interested in putting your name forward for election, please, firstly, read the attached Working Group Chairs’ Code of Conduct and Roles and Responsibilities documents. To apply, please send a short biography and motivation letter, stating whether you intend to run for Co-Chair or Vice Chair to Ms. Jessica YUAN at jyuan@europeanchamber.com.cn by Wednesday, 12 March 2014, 4pm.
Tentative Agenda
- Opening (Co-Chairs and Vice Chairs) to summarize WG activities in year 2013
- Topics for Y2014 – Champions to present the working plan
- 2014-2015 Co-Chair/Vice Chair Election