On March 23, 2016, the CFDA has released its Quality Management Regulations for Medical Device Clinical Trials
QUALITY MANAGEMENT REGULATIONS FOR MEDICAL DEVICE CLINICAL TRIALS 続きを読む »
On May 27, 2016, the China Food and Drug Administration issued the annual monitoring report of medical device
ADVERSE EVENTS MONITORING REPORT FOR YEAR 2015 – CHINA FDA 続きを読む »
“The Requirements of Application Materials for Special Approval of Innovative Medical Devices (The Draft)”, pu
The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medi
New Consultation Guidelines from Center of Medical Device Evaluation (CMDE) 続きを読む »
The China Food and Drug Administration released the draft “List of Clinical Trial Exempt Devices – Second List
“Since New Zealand gets the first rays of sunlight, why not be the first to receive the face-2-face training f
It’s Ready for Publication! Finally, the long-awaited revision of ISO13485 is approved for publication &
Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation 続きを読む »
Revision development of the International Standard ISO13485 has reached the final stage, with the voting by th
ISO13485 Revision Reaches The Final Stage 続きを読む »
A newbie’s view of a healthcare entrepreneur’s gathering. I became part of the www.meetup.com comm
An opportunity came up to help provide clarity on some of the specifics within ISO13485 during a regional conf