Guidance Document: Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations - Summary

From Health Canada

Overview

This guidance document provides medical device stakeholders with information on the requirements that the Therapeutic Products Directorate will use in recognizing Auditing Organizations under the Medical Device Single Audit Program.

Who this guide is for

• Medical Device stakeholders

In this guide

• 1. Introduction
  • 1.1. Purpose/Overview
  • 1.2. Scope and application
  • 1.3. Policy objectives
  • 1.4. Background
• 2. Guidance for Implementation
  • 2.1. MDSAP Consortium responsibilities
  • 2.2. TPD’s responsibilities
  • 2.3. Auditing organizations
• 3. Appendices
  • 3.1. Appendix A – Glossary
  • 3.2. Appendix B - References
  • 3.3. Appendix C – General Overview of Auditing Organization Assessment and Recognition Decision Related Processes

View complete guide
Download PDF (622 KB, 11 pages)

Details and history

• Published: November 21, 2018
• Updated: n/a
• Consulted: July - August 2018
• Part of topic(s): Guidance on legislation

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