HCE WG
Meeting opportunities to discuss medical device standards with EU and Chinese experts on March 30th and April 1st
Dear Working Group Members,
You are cordially invited to two meetings on standards hosted by the Chamber:
1. Meeting with ESOs and DG ENTR on March 30th
Per request from the visiting DG Enterprise and three major European Standard Organizations (European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC) and European Telecommunication Standards Institute (ETSI), the Chamber is organizing a meeting for our members to discuss specific issues regarding standards the industry is facing with those ESOs, before they meet with their Chinese counterparts like SAC and CNIS. The meeting is tentatively scheduled at 8:30, Monday 30 March, 2009 at the Chamber’s Beijing office.
A 15 minute slot is given to the Healthcare Equipment Working Group to present our concerns on Medical Device Standards. Input from members will be greatly appreciated. Should you have any specific issues to raise and/or any other comment on China’s Medical Device Standards, please send them along with your availability to Ms. Sophie Zhang at szhang@euccc.com.cn by March 27th, 2009.
2. Meeting with project leader of EU Medical Device Standards Study Project sponsored by SFDA
With the success release of the Medical Device Expert Roundtable (MDER) report, SFDA is sponsoring a research project on EU Medical Device Standards lead by Beijing Institute of Medical Device Testing (BIMT) and Center for Medical Device Evaluation (CMDE), both of which are affiliated to SFDA. A meeting between the study project leader and HCE WG members will be held at EUCCC Beijing Office from 16:30 to 17:15 on Wednesday, 1st April, 2009. Representatives from DG ENTR and ESOs will also be present.
Since the main purpose of this study project is to develop in-depth understanding of the European Regulatory and Standardization System and consequently make recommendations to SFDA officials how to better gear China’s medical device standards system towards international standards, industry input from our members is crucial to shape the study in its planning stage. Attached please find a preliminary Study Proposal from SFDA. For detailed information on the study project, please contact Ms. Yujie Bao at yabo@eucc.com.cn
Please kindly note that as seats are limited, reservation will be made on first-come-first-served basis, preferably 1-2 representatives per company. Members are welcome to attend both meetings. Please indicate which meeting you want to go to and confirm your participation with Ms. Sophie Zhang at szhang@euccc.com.cn by March 27th, 2009.
To download the proposal in PDF, please click here.