Categories: General
      Date: Jul  4, 2013
     Title: What’s new in the Regulatory/Quality World!

News and Notes on Regulatory Affairs and rule updates around the globe...

Regulatory decisions that improve patient access to safe and effective, innovative medical devices... click "More" for details!

The FDA is holding a public workshop:  "Battery Powered Medical
Devices, Challenges and Opportunities" in Silver Spring, MD on 30-31 
July 2013: http://www.gpo.gov/fdsys/pkg/FR-2013-06-05/html/2013-13244.htm?source=govdelivery

There are enormous changes coming for medical devices in the EU; CE 
Marking is never going to be the same:  http://ec.europa.eu/health/medical-devices/documents/revision/

Health Canada has recently updated their Quality System Framework for 
compliance and enforcement: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/activit/qsf-csq-eng.php

New regulatory guidelines from the land down under!  Australia TGA has 
published updates for Prescription Medicines: http://www.tga.gov.au/newsroom/media-2013-argpm-130603.htm and for biological: http://www.tga.gov.au/industry/biologicals-standards.htm