China’s CFDA has released a draft proposal for fast track review of submissions which bring new technologies to areas of clinical priority or current unmet needs. Devices which address national research priorities, cancer, pediatrics or geriatrics or any area with a currently unmet clinical need stand to get priority review.
Archives for June 2016
What does UK’s decision to exit the European Union mean for the UK market and for the CE marking of medical devices and IVDs. We take a look at the issue from the perspectives of manufacturers, Notified bodies and the MHRA and ask – should MHRA take a leaf out of the Australian TGA’s book?
As June 30 approaches in the depths of the Australian Winter, manufacturers should do a little early Spring cleaning. Any registration which are no longer needed should be cancelled – or you will be liable for another Annual Fee. Time to clean house…
TGA has circulated communications to all Australian Sponsors notifying that the Annual Charge Exemption (ACE) applications must be submitted between July 1 and 22, 2016. Most importantly – doing nothing means TGA automatically assumes that there have been sales and the exemption is lost.
The long awaited refresh of US FDA’s biocompatibility guidance has finally arrived. This is a quantum leap from the old G95-1 Blue Book Memo. The guidance is firmly rooted in a risk based approach, and provides detailed advice on all aspects of biological safety evaluation. The controversial modified Table from ISO 10993 still remains, however parallel activities in ISO may see the new version of ISO 10993 coming into close alignment with FDA’s view.
Following the well publicised crackdown on drug trials, CFDA is now turning attention to devices and IVDs with a new program of audits and inspections.