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。
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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
New Consultation Guidelines from Center of Medical Device Evaluation (CMDE)
The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medi
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List of Clinical Trial Exempt Devices – Updated List by China Food and Drug Adminisration (CFDA)
The China Food and Drug Administration released the draft “List of Clinical Trial Exempt Devices – Second List