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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 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 […]

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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). 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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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, 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

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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 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

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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 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

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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 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

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Access-2-Healthcare Partners with Rob Jelas Regulatory Training & Assistance to Help New Zealand manufacturers Understand ISO13485:2016

“Since New Zealand gets the first rays of sunlight, why not be the first to receive the face-2-face training for the new ISO13485 from us?” With the release of the ISO13485:2016 on March 1st, Access-2-Healthcare and Rob Jelas embarked on a journey to engage with the NZ medical device manufacturing industry in an aim to

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Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation

It’s Ready for Publication! Finally, the long-awaited revision of ISO13485 is approved for publication   And as I travel around, met people and chatted about the possible impact to the medical device industry and specifically to any organisation’s quality management system, it became apparent that perhaps the process of standards development in ISO and the efforts

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Of Hopes And Dreams

A newbie’s view of a healthcare entrepreneur’s gathering. I became part of the www.meetup.com community out of interest and joined one of the groups “Singapore Medical Technology Entrepreneurs” Well, the name of the meetup group sounds about right for me, and all this is for free, so, can’t go wrong, right?  :-)…..what’s next? I actually went to one event

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