Dear Healthcare Equipment Working Group Members,


***The European Chamber is delighted to invite you to attend the next HCE WG, which will be held at 13:30 on Thursday 11th March 2010 at both the EUCCC Beijing and Shanghai Offices.


The meeting will focus on updating members on recent and forthcoming lobby actions. Being the first working group meeting of the year, it will also focus on providing information on scheduling and requirements for the drafting of the 2010/2011 Position Paper as well as scheduling and procedures for the election of HCE WG Chairs and Vice Chairs. A tentative agenda for the meeting is attached below. Please feel free to share your comments and suggestions.

Tentative Agenda

1.     Recent Lobby Activities
        a.     MoH Supplemental Tendering.
        b.     SFDA Registration License Extension, including follow-up actions.
        c.     SFDA–CMDE: Call for Comments on the Technical Guidelines for Implantable  Cardiac  Pacemakers Principle.
        d.     SFDA-CMDE: Joint submission together with NEMA and JIRA of a Call for
                Comments  on the Draft Technical Guidelines for Ultrasonic Diagnostic Imaging Equipment.
        e.     SCLAO: Call for comments on Draft Implementation Regulations on Government  Procurement Law.
        f.      MOST, NDRC, MOF: Lobby letter on Notice #618 on Indigenous Innovation Product Accreditation Catalogue.
        g.     Meeting with MIIT regarding environmental regulations affecting medical devices as well as a potential refurbishment pilot.
        h.     Feasibility Study update.

2.     Upcoming Lobby Actions
        a.     Meeting with Deputy DG Wang Yunhe, recently appointed Director of the Medical Device Standards Management Centre.
        b.     Lobby letter and meeting request to the SFDA on new regulations for GMP.
        c.     Follow-up lobby letter and meeting request on Product Defective Recall.
        d.     MOH programs, including ‘The Rules of National Medical Services Pricing Items’ and the potential impacts on pricing.
        e.     DG ENTR’s DG Zourek’s visit to China in late March.
        f.      COCIR activities: Roundtable meeting on IEC 60601-1 3rd edition, potential forum  on eHealth, cooperation on a ZVEi organised seminar
               on medical device regulation under the cooperation program between the German Ministry of Economics and the NDRC
               on technological cooperation, refurbishment pilot program, cooperation on the CCPIE International Forum on Medical Device Regulation.

3.     Upcoming EUCCC Activities
        a.     2010/2011 Position Paper: scheduling and requirements
        b.     Chair Elections: scheduling and procedures.

 To participate in this WG meeting, please send your registration to Mr Jon Zhao at the email address: jzhao@euccc.com.cn before 18:00 on 10 March 2010. Please also kindly specify whether you will attend this meeting in Beijing or Shanghai.

 To better prepare for this meeting, the following documents, relevant for different items in the proposed agenda, are attached for your reference:
 

Ref. Agenda Item No.
 Document Title
 
1 a
 ·         ‘MoH_Notice_Matters concerning the national tender for centralized procurement of the high-value medical consumables_No 12_EN’
1 d
 ·         ‘COCIR- NEMA- JIRA关于《影像型超声诊断设备技术指导原则》（征求意见稿）的反馈’
1 e
 ·        ‘20100202Consolidated_Comments_on_Draft_Implementing_Rules_onGovernment_Procurement_Law Final’
·         ‘100209 CCOIC Roundtable Discussion Lobby Report’
1 f
 ·         ‘20100208_Joint Meeting on China Indigenous Innovation_Meeting Minutes’
1 g
 ·         ‘27 01 10 - Meeting Minutes on COCIR meeting with MIIT on RoHS EuP BOMcheck - FSHJZ _3_’
1 h
 ·         ‘AdvaMed-AmCham-Eucomed-EUCCC to NDRC FINAL 25-01-2010’
2 a
 ·         ‘22 02 10 Meeting request to Wang Yunhe MDSMC En+Cn REV ZIE (2) (2)’   

Click to download all_attached_documents

Please note that another Healthcare Equipment Working Group will be arranged for the week following this meeting, in the early afternoon of March 19th. This meeting will focus purely on the HCE WG Chairs and Vice Chair elections and on preparations for the writing of the Position Paper. Confirmation and further information on this important meeting will be sent to all members shortly.


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For any further information about the Healthcare Equipment Working Group, general enquiries such as Membership with the European Chamber or our partner associations, please contact Mr. Mark Rushton (for COCIR) at mrushton@euccc.com.cn in Beijing or Ms. Penny Zhao (for Eucomed) at yzhao@euccc.com.cn in Shanghai

 

For more information, please visit: http://www.europeanchamber.com.cn/view/about/contactus

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