On March 11, 2016, the CFDA has released its first issue (nine in total) of national medical device quality an […]
CFDA – 47 ENTERPRISES WERE CHASTISED IN THE CFDA QUALITY ANNOUNCEMENT 続きを読む »
Nifty Tips on calculating Product License renewal timelines for the CFDA On September 26, 2016, the CFD
China FDA – Don’t Miss the Boat! 続きを読む »
Everyone’s gone to a clinic at some point in time: you get in you register you wait you get in to see th
Health Tech Speed Clinic – in collaboration with Institute of Systems Science, NUS 続きを読む »
The Beijing Municipal Food and Drug Administration released its directive on GMP certification of medical dev
一切都是从一场双方友好地交谈开始，逐渐发展成为台湾工研院与 Access-2-Healthcare 之间更多正式地交流并最终决定在2016年7月7日在台北举行关于医疗器械行业应对 ISO13485 更新和转换过程的培训。
Access-2-Healthcare偕同台湾工研院对台湾医疗技术行业普及ISO13485：2016更新内容 続きを読む »
What began as a friendly conversation between two blokes, led to a few more serious discussions and thus the t
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 »