Nifty Tips on calculating Product License renewal timelines for the CFDA On September 26, 2016, the CFDA Administrative Services issued a statement on applicable information with regards to the renewal of the product registration license for medical devices (No. 179), clarified that the submission time of application for the renewal registration of medical devices […]
Everyone’s gone to a clinic at some point in time: you get in you register you wait you get in to see the doctor doctor listens to you doctor does diagnostics doctor quizzes you more doctor gives you the prognosis you grab the medication and you’re free to go (after paying) Right? This is what
Health Tech Speed Clinic – in collaboration with Institute of Systems Science, NUS Read More »
The Beijing Municipal Food and Drug Administration released its directive on GMP certification of medical device manufacturers under its jurisdiction: 156 sterile, implantable medical device manufacturers, 119 IVD reagent manufacturing enterprises, and 111 manufacturers of Class Ⅲ medical devices have met the requirements. According to the “Notice of Beijing Municipal Food and Drug Administration’s Implementation Plan
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。 虽然台风在培训后的第二天席卷了台湾（在此对注册本次培训的人员表示抱歉）。我们将计划在10月6日和7日在台北和台南分别进行两场培训。对于错过这次培训的企业，欢迎加入我们的下次培训！ 借此机会我想在这里感谢工研院 – 特别感谢李主任, 王國烜及陳道平的热情款待，及时的帮助以满足大家的需求，顺利完成培训。这也是工研院同事一贯秉持的至始至终地细致为一级棒，并对工研园一贯高水准的处事方案给予感谢！ 我们再次在十月相会吧！ English Version 英文版
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 Read More »
What began as a friendly conversation between two blokes, led to a few more serious discussions and thus the training on the ISO13485 transition to the Taiwan medical device industry, jointly presented by Industrial Technology Research Institute (ITRI) and Access-2-Healthcare, on 7 July 2016, at the ITRI College in Taipei. This training course is unique in the sense
On March 23, 2016, the CFDA has released its Quality Management Regulations for Medical Device Clinical Trials (CFDA Decree 2016 No, 25). The Regulations will come into effect on June 1, 2016. 1. The formulation background of the Regulations In 2004, the former SFDA released the Provisions for Medical Device Clinical Trials. However,
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On May 27, 2016, the China Food and Drug Administration issued the annual monitoring report of medical device adverse event for 2015, which included an overview of medical device adverse events, statistical analysis, measures for ensuring the safety of medical x-ray angiographic machines, external defibrillators and low-frequency electromagnetic therapy equipment etc. The report comprehensively reflects
ADVERSE EVENTS MONITORING REPORT FOR YEAR 2015 – CHINA FDA Read More »
“The Requirements of Application Materials for Special Approval of Innovative Medical Devices (The Draft)”, published by National Food and Drug Supervision and Administration of Medical Evaluation Centre on May 3, 2016, is now soliciting for public comments until the deadline on May 31, 2016. Following is our analysis of The Draft Let
The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medical Device Evaluation Consultation” for public comment on May 20, 2016, with comments solicitation period concluding on June 5, 2016. For future product registration – according to these draft guidelines – face-to-face consultation shall be limited to 3 sessions of
New Consultation Guidelines from Center of Medical Device Evaluation (CMDE) Read More »
The China Food and Drug Administration released the draft “List of Clinical Trial Exempt Devices – Second Listing” for public comment on May 20, 2016. This draft indicates CFDA’s increased governance on a wider range of medical devices and its assessment on the clinical trial requirements and expanded the list of clinical trial exempt devices. This