Meeting with the SFDA-CMDE on the drafting of Technical Guidance Documents for X-Ray Equipment

2010-05-19 | All chapters

Issues discussed:
1) Software registration
2) Medical device risk evaluation report
3) Grouping principle on registration testing sample unit selection
4) Clinical trials exemption
5) New technology clinical trials
6) After-sales services

Many of the comments of the European Chamber, COCIR, Advamed and NEMA members were accepted to be included in the final CMDE draft. Members are, on the whole, very happy with the revisions being made.