1. Debriefing on:
-  Position Paper presentation to NDRC Department of Law & Regulation
-  Position Paper presentation to SFDA Commissioner Shao Mingli
-  Position Paper presentation to SAIC Vice Minister Fu Shuangjian
-  Position Paper presentation to SCLAO Vice Minister Yuan Shuhong 

2. Discussion on two Draft for Comments: SFDA revised draft on Order 16 and       AQSIQ Draft on Defective Product Recall

3. Discussion on 2nd draft of ’09 EUCCC HCE Position Paper

4. AOB

HCE Working Group

1.       01 June 2009 Meeting Minutes
2.       Position Paper Final Draft


Dear Healthcare Working Members:

***Special thanks to all members who have participated in and shared valuable inputs during the HCE meeting on 1st June 2009. For your reference, the Meeting Minutes is attached to this email along with the following attachments: 

1) Cover letter to SCLAO on Measures for Defective Product Recall (Bilingual)

2) Consolidated comments submitted to SCLAO on Measures for Defective Product Recall

3) Consolidated comments on SFDA on Measures for the Administration of Medical Device Registration (Bilingual)

***Regarding to the HCE Position paper, please find the Final Draft of the 2009/2010 HCE Working Group Position Paper attachedfor your reference.  The Content in this document has been decided by the Chairs of the HCE WG, in consultation with the authors, and final proofreading will be done by the Chamber Secretariat. At this stage, members are on long required to contribute any comments on substantive changes.

Should you have any objections to this document, we invite you to contact Ms. Yujie Bao at ybao@euccc.com.cn or Ms. Penny Zhao at yzhao@euccc.com.cn before 10:00 am, 19th June 2009. Absence of comments will be considered as silent endorsement.
 
Kindly note that this advance copy is strictly confidential and should under no circumstances be communicated to third parties before the Position Paper is officially released in September.
 

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053109_consolidated_comments_to_sfda_on_registration_measures_eng

061109_minutes_hce_wg

061309_final_draft__euccc_hce_pp

090526_combined_comments_def_recall_fb_hce_lig

090526_cover_letter_to_slcao_on_industry_comments_on_defective_product_recall_cn

090526_cover_letter_to_slcao_on_industry_comments_on_defective_product_recall_en

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Supplementary Discussion Materials

HCE WG Meeting
Monday, 1stJune 2009, 9:00 - 11:00 AM
EUCCC Beijing Office:Beijing Lufthansa Center, Office C412, 50 Liangmaqiao Road
EUCCC Shanghai Office: Unit 2204, Shui On Plaza, 333 Huai Hai Zhong Road
 

Dear Working Group Member,
 
We are delighted to invite you to the next HCE WG meeting on Monday, 1st June starting from 9:00 AM at the European Chamber Offices in Beijing and Shanghai. The tentative agenda is enclosed below for your reference.
 
For your preparation for this meeting, please kindly review the attached documents in advance:
 
1. 2nd Draft of HCE ’09 Position Paper

Please find attached the most recent version of this year's HCE Position Paper that is available for your FINAL comments by Wednesday, 3 June.  The inclusion of any further revisions to this document beyond that point will be decided by the Chairs of the HCE WG, in consultation with the lead authors, and final proofreading done by the Chamber Secretariat.

If you have submitted comments and it is not yet reflected in this draft, please accept our apologies while we review and consolidate your valuable input.  Should you have any further comments, please feel free to respond in track changes in the document and send them to Ms. Catherine Chou at cchou@euccc.com.cn by COB Wednesday, 3 June.

2. EUCCC Joint Working Group comments submitted to the Legislative Affairs Office of the State Council on Measures for Defective Product Recall on May 26, 2009

(To download, cover letter in Chinese & English; combined comments)

AGENDA (tentative):

•  Debriefing on:
- Position Paper presentation to SFDA Commissioner Shao Mingli
- Position Paper presentation to SAIC Vice Minister Fu Shuangjian
- Position Paper presentation to SCLAO Vice Minister Yuan Shuhong
• Discussion on two Draft for Comments: SFDA revised draft on Order 16 and AQSIQ Draft on Defective Product Recall
• Discussion on 2nd draft of ’09 EUCCC HCE Position Paper
• Forward Agenda
 
To attend this meeting, please register with Ms. Catherine Chou at cchou@euccc.com.cn by Friday, 29th May COB.

Thanks for your continuous support!

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