European Union Chamber of Commerce

Healthcare Equipment (HCE) Working Group (Beijing & Shanghai)

Working Group Meeting (face-to-face)
Date & Time: 15:00, Wednesday 8 January 2014
Venues:

 1) European Chamber Beijing, Office C411A, Beijing Lufthansa Center, 50 Liangmaqiao Road, Chaoyang District

北京市 朝阳区亮马桥路50号 燕莎中心写字楼 C-411A室

2) European Chamber Shanghai, Shui On Plaza, Unit 2204, 333 Huai Hai Zhong Road (near Madang Road)

上海市淮海中路333号瑞安广场2204室 (近马当路)

Please kindly register online or reply by email to: hce@europeanchamber.com.cn  by 6^th January, 2014, specifying whether you will attend in Beijing or Shanghai.

Dear Working Group member,

The European Chamber HCE Working Group invites you to attend our upcoming working group meeting at 15:00h on Wednesday, the 8^th of January, 2014 at the European Chamber Shanghai and Beijing Offices.

Agenda:

15:00 – 15:30      WG priorities in 2014 (lead by Carol Yan – Johnson & Johnson and Tracey Gao - Siemens)
15:30 – 15:50      Discussion on ‘Class II Medical Device Clinical Trial Requirements for Registration Purpose’.
Here we have the honour to invite Ms LI Xintian (李新天) Jiangsu FDA, who is responsible for collecting, categorizing and including industry suggested Class II MD into the list exempt for clinical trial, to join our discussion by telephone and talk about specific requirements for making this list as inclusive as possible, to cover as much industry’s comments as possible.
15:50 – 16:20      CFDA Notice 9th 2013 about Re-Registration (lead by Ms. Victoria Qu, Johnson & Johnson)
16:20 – 16:40      Discussion on New decree 276, Decree 16 for registration (In this Decree, product standard for registration will be replaced by Product Technical Requirements (产品技术要求)),  the possible impact and members’ opinions. (lead by Ms. Tracey Gao, Siemens)
16:40 – 16:50      Discussion on possible workshop with Medical Device Supervision Dept. to establish the network and also have professional discussion about post market surveillance. (lead by Ms Tracey Gao, Siemens)
16:50 – 17:00      Discussion on Tender (lead by Ms. Rosely Liu, Smith-Nephew)

Please kindly note that to ensure the efficiency, the discussion will be mainly conducted in Chinese, we welcome member companies bring your Chinese colleagues to the meeting together with you, as the Chamber may not give extra time for the bilingual translation.

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