Health Canada issued three new guidance documents in June 2011.
- Guidance Document For The Interpretation Of Significant Change
- Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices
- Guidance On The Content Of Quality Management System Audit Reports
You can download the documents from http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php
The significant change guidance uses a series of flow charts to help the user classify changes. The guidance document has a main flowchart that leads to others as listed below.
Main Flowchart: General changes made to devices
Flowchart A: Changes in manufacturing processes, facility or equipment
Flowchart B: Changes in manufacturing quality control procedures
Flowchart C: Changes in design
Flowchart D: Changes to sterilization
Flowchart E: Changes to software
Flowchart F: Changes in materials for non in vitro diagnostic devices (IVDDs)
Flowchart G: Changes in materials for IVDDs
Flowchart H: Changes to labeling
The reusable device guidance explains how the regulations apply to each class of device. The guidance provides a table format, based on CAN/CSA/ISO 17664, for reprocessing instructions.
The audit report guidance contains information on the preparation and content of QMS audit reports. This guidance uses work of the Global Harmonization Task force (GHTF) Study Group 4, in particular, SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports.
The guidance also supports the US FDA’s Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.