TSXV:VER.H - Post by User
Comment by
firesIayer96on Dec 17, 2011 7:59pm
409 Views
Post# 19332338
RE: RE: RE: RE: JUST ABOUT DONE !!!
RE: RE: RE: RE: JUST ABOUT DONE !!!EBS TGA Public Summary has now been updated to include Manufacturers Name: Verisante Technology Inc. and Address:
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=193163&agid=(PrintDetailsPublic)&actionid=1
https://www.tga.gov.au/pdf/devices-argmd-p1.pdf
The following is an excerpt from above found at the Australian regulatory guidelines for medical devices (ARGMD):
For a medical device to be included in the ARTG, the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device.
If this isn't official yet, as retiredcop says, looks as though we are very close to an official declaration.
All these approvals by years end seemed overly ambitious to me as recently as September.
Kudos to VRS management and their consulting teams.
Congrats to all 'longs'.