Health Canada issued the draft guidance for comment. This guidance, for Class III and Class IV devices, uses the Global Harmonization Task Force (GHTF) approach to documentation.
The GHTF developed the Summary Technical Documentation (STED) approach to encourage and support convergence of regulatory systems for medical devices among jurisdictions. Health Canada has adopted use of the STED for premarket license applications and license amendment applications for Class III and Class IV medical devices. Although the use of the STED is not mandatory, Health Canada strongly encourages manufacturer’s to follow this guidance when submitting Class III and IV medical device license applications and amendment applications.
The comment period ends on December 12, 2010.
You can obtain a copy of the draft guidance and information on submitting comments at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/md-im/md_draft_gd_im_ebauche_ld_sted-eng.pdf