Dear Member,
It has been truly an eventful time since our last Healthcare Equipment Working Group meeting on 4th Sept:
- SFDA has issued its draft Regulation on Supervision and Administration of Medical Devices ("Decree 276"),
- members of the Asian Harmonization Working Party (AHWP) met in Chengdu end of Oct,
- the Chamber participated at several meetings with AQSIQ and met the State Council Legislative Affairs office as well as NDRC and the BJ Health Bureau,
- and last but not least the EU Commission (DG ENTR) signed with SFDA a Memorandum of Understanding
just to name a view important happenings.
In order to share the most recent information, discuss priorities and our next actions the European Chamber is organising a next HCE WG meeting at the Chamber office in Beijing on Tuesday, December 5th from 9 to 11.00 am. Please find attached for your reference the two letters which has been sent to the State Council and SFDA, respectively.
Pre-info on Order 95 to be effective 1st Dec 2007: Although engaged through several channels and the highest (political) levels, AQSIQ has not yet (officially) announced any decision about the postponement of the implementation of Order 95. However, with the implementation guidelines and catalogue not having been disclosed and as hinted by another Sate Administration it is most likely that the implementation date will be delayed.
Agenda:
1. Review of 2007 group activities and status report [start 9.00]
2. Status and next steps incl: [start 9.20]
- Revision of Decree 276 (SFDA-industry meeting request pending, notification to be send to members asap)
- DRAFT SFDA Regulation on Supervision of Distribution of MDs (see separate e-mail Nov 20)
- DRAFT SFDA Administrative Measure on Medical Device Recall (issued Sept 20, comments submitted to SFDA)
- AQSIQ Order 95 / CNCA
- NDRC - proposed pricing regulation
- BJ HB - High Value Consumable Centralized Purchase
3. Planning for 2008 incl: [start 10.10]
- Introduction of possible EU China MD Expert Roundtable
- Possible strategy meeting in January in SH
- Review of priorities
- AHWP follow up e.g. regulatory training program with Northeastern University
4. Standardization in PRC and industry participation [start 10.40]
5. AOB [start 10.50]
The Chamber looks forward to welcoming you at this meeting and we would appreciate if you could indicate your attendance with Ms Yuan Jin at jyuan@euccc.com.cn .
Please feel free to indicate any other topic of interest ahead of the meeting. For any questions and clarification please contact us.
Thank you for your support.
Best regards,
Maurizio and David