Moving On – China FDA – 7 Notices of Personnel Appointments
On March 17, 2016, the CFDA has consecutively issued 7 notices of personnel appointments and dismissals, and t […]
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CFDA – 47 ENTERPRISES WERE CHASTISED IN THE CFDA QUALITY ANNOUNCEMENT
On March 11, 2016, the CFDA has released its first issue (nine in total) of national medical device quality an
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China FDA – Don’t Miss the Boat!
Nifty Tips on calculating Product License renewal timelines for the CFDA On September 26, 2016, the CFD
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Health Tech Speed Clinic – in collaboration with Institute of Systems Science, NUS
Everyone’s gone to a clinic at some point in time: you get in you register you wait you get in to see th
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Class III Medical Device Manufacturer’s GMP Certification – Beijing Municipal Food and Drug Administration
The Beijing Municipal Food and Drug Administration released its directive on GMP certification of medical dev
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
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 »
Access-2-Healthcare partners with Industrial Technology Research Institute of Taiwan to help Taiwan medical technology organisations understand ISO13485:2016
What began as a friendly conversation between two blokes, led to a few more serious discussions and thus the t
QUALITY MANAGEMENT REGULATIONS FOR MEDICAL DEVICE CLINICAL TRIALS
On March 23, 2016, the CFDA has released its Quality Management Regulations for Medical Device Clinical Trials
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ADVERSE EVENTS MONITORING REPORT FOR YEAR 2015 – CHINA FDA
On May 27, 2016, the China Food and Drug Administration issued the annual monitoring report of medical device
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Release for Public Comment – Registration Requirements for Innovative Medical Devices – China FDA
“The Requirements of Application Materials for Special Approval of Innovative Medical Devices (The Draft)”, pu