“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
“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
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
Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation Read More »
Revision development of the International Standard ISO13485 has reached the final stage, with the voting by the Participating (and Observing) members of the FDIS ongoing till the end of this calendar year (2015). On May 2015, I represented the ISO TC210 Workgroup 1 committee and presented some of the revision highlights in an Asia Pacific Medical Device Forum. They include:
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
An opportunity came up to help provide clarity on some of the specifics within ISO13485 during a regional conference recently. These slides provide explanation to some of the terms and phrases within the Standard. Hope it helps the auditee and the auditor of any medical device company, or certification company, understand the ISO13485 Standard better.
I remember with fondness of my late mother chatting with me while she was working on her clothes on her Singer sewing machine during my teens, about human relationships. “Know what you want, know what the other person wants. Keep trying till it works and always remember to take nothing for granted” Sound advice for me, which I
Learning Process Validation through Human Relationships Read More »