Health Canada has made substantial changes to Medical Device Regulations and supporting guidance documents that should be considered by organizations that are involved with medical devices in form of Medical Device Establishment License (MDEL) or Medical Device License (MDL).
These changes include:
– September 21, 2011 – Medical Device Regulations MDR
– October 3, 2011 – Guidance Document for Mandatory Problem Reporting for Medical Devices – Canada Vigilance Medical Device Problem Reporting.
– March 25, 2011 – Guide to Recall of Medical Devices – GUI-0054
– March 25, 2011 – Guidance on Investigation of Reported Medical Devices Problems – GUI-0065
– October 1, 2010 – Guidance on Risk Classification of Medical Devices Observations – GUI-0079
– April 1, 2011 – Guidance Document for the Interpretation of Significant Change
For other Health Canada Guidance documents visit:
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php#guidance_devices