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1.         Medical Devices Regulations(2015)

2.         Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees(2013)

3.         Fees for the Review of Medical Device Licence Applications(2013)

4.         Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices(2013)

5.         Medical device establishment licence application: form and instruction(FRM-0292)(2012)

6.         How Health Canada inspects medical device establishments (2016)

7.         Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)(2012)

8.         Policy on the Canadian medical devices conformity assessment system quality systems(2000)

9.         ISO 13485 (2003) Quality Management System Audits Performed by Health Canada Recognized Registrars

10.    Risk classification of GMP observations(2012)

11.    Opportunity to be Heard in the Suspension of a Medical Device Licence(2011)

12.    Guidance Document: Preparation of Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic Devices (IVDDs)(2011)

13.    Guidance for the Interpretation of Significant Change of a Medical Device(2011)

14.    Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices(2011)

15.    Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device(2011)

16.    Guidance Document - How to Complete the Application for a New Medical Device Licence(2011)

17.    Guidance Document - Private Label Medical Devices(2011)

18.    Good Manufacturing Practices Guidelines(2009)

19.    Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations(2006)

20.    Cleaning validation guidelines(2008)