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Our Insight Blog shares our thoughts from Ground Zero, medical technology industry information, regulatory updates, and past issues of our vaunted monthly newsletter “MedTech Gateway”

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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 CFDA Administrative Services issued a […]

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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 […]

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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 device manufacturers under its jurisdiction: 156 sterile, […]

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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。   本次培训课程之独特之处由两位TC210 WG1成员Albert 李子偉主任及廖裕斌主讲,他们均参与撰写和修改目前的实行的标准。同时本次课程将全程采用中文培训。  Albert和我从质量系统发展及ISO13485 历史为起点,讲述TC210 委员小组的补充及标准的修订。同时系统地逐条讲解新旧标准之间的差异和台湾GMP关联。最后还有关于要点讨论,怎样计划应对转变,当然也包含了提问及回答环节     尽管本次培训针对的是目前已认证的生产商,但是仍然吸引了包括准备产品上市的医疗技术机构,医疗进口商,研发中心及未部分未经认证的生产企业来参与。这也预示着这些机构认同目前现行的标准适用于所有类型的机构包括供应链至产品生命周期在内的所有环节。       就如Access-2-Healthcare 几月前在新西兰的培训一样,本次培训也涉及到一些特殊关于设计到软件的认证,风险评估,同时还涵盖了设计认证部分的内容的问题。由此也说明了不同地域或者文化的企业都会有相同或者类似的问题或者顾虑。       这次距离上次我在台湾的日子差不多有一年多的时间。很偶然的情况下我在培训的同时还遇见了一些久违的朋友。我的一大爱好是台湾夜市的食物,这次在朋友的引导下也尝到了物超所值的寿司。   […]

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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 training on the […]

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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 (CFDA Decree 2016 No, 25). […]

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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 adverse event for 2015, […]

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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)”, published by National Food and Drug Supervision and […]

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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 Medical Device Evaluation Consultation” for public […]

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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 Listing” for public comment on […]

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