Dear Member,
Since our last Healthcare Equipment Working Group meeting on 1st June we have attended two important meetings with AQSIA and SFDA (CAMDI). In order to share our findings and agree on the industries next actions the European Chamber is organising a next HCE WG meeting at the Chamber’s office in Beijing on Tuesday, September 4th from 9 to 11.00 am.
Reminder: Please remember to submit your comments regarding the revision of the State Council decree 276 [April 1, 2000]: Medical Devices Administration Regulations and SFDA order 16 [May 28, 2004]: Measures for the Administration of Medical Device Registration until Friday, 31st August 2007 (see EUCCC mail August 8) or kindly prepare for the WG meeting below your company position. I have attached the draft comments for Decree 276 and Order 16 for your reference. Please use this document for your inputs.
Meeting agenda:
1. Follow-up of meeting with AQSIQ on Order 95 (meeting de-brief and next action) [start 9.00]
2. Comments on SFDA Order 16 and State Council Decree 276 (Follow-up of CAMDI conference 17th Aug) [start 9.30]
3. Actions on SFDA Implementation Guideline of State Council Order 503 (Special Regulation on Strengthening Supervision and Administration of Food and Other Products Safety) [start 10.30]
4. 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 Maurizio Andreano on mandreano@euccc.com.cn . Please feel free to indicate any other topic of interest ahead of the meeting.
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For any further information about the Healthcare Equipment Working Group or the European Chamber in general please do not hesitate to contact Maurizio Andreano at mandreano@euccc.com.cn or David Lee at dlee@euccc.com.cn .