Guidance Documents

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in Canada. Guidance documents are designed to be living documents and will be revised as necessary.

Cost Recovery

Good Guidance Practices

Medical Devices Global Harmonization Task Force

Medical Devices Guidance Documents

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Cost Recovery

How to Pay Fees
Date: 2004-11-22

Guidance Document on Cost Recovery - Fees in Respect of Medical Devices
Date: 2002-02-01

Medical Devices Guidance Documents

Draft Guidance Document for the Interpretation of Significant Change
Date: 2009-07-14

E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
Date: 2008-07-29

Guidance Document: Submission of Pharmacogenomic Information
Date: 2008-05-23

Draft Guidance Document -- Schedule A and Section 3 to the Food and Drug Acts
Date: 2008-07-23

How to Complete the Application for a New Medical Device Licence
Date: 2008-05-01

Bis(2-ethyhexyl) phthalate (DEHP) and Bisphenol A (BPA) - Questions & Answers
Date: 2008-08-15

Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards
Date: 2008-03-17

Bed-related Entrapment and Fall Report Form
Date: 2008-03-17

Draft Guidance Document: Information to be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices
Date: 2006-12-04

Notice: Updated Guidance on the Recognition and Use Of Standards under the Medical Devices Regulations
Date: 2006-09-22

Guidance Document: Recognition and Use of Standards under the Medical Device Regulations
Date: 2006-09-22

Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices
Date: 2006-09-14

Guidance for Industry - Medical Device Licence Renewal
Date: 2005-08-17

Guidance for Industry: Device Licence Applications for Ultrasound Diagnostic Systems and Transducers
Date: 2005-07-18

Guidance for Industry - Private Label Medical Devices
Date: 2005-06-01

Private Label Medical Devices: Questions and Answers
Date: 2005-06-01

Guidance for Industry: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device
Date: 2005-06-01

Application for a New Medical Device Licence for a Private Label Medical Device
Date: 2005-06-01

Application for a Medical Device Licence Amendment for a Private Label Medical Device
Date: 2005-06-01

Guidance document on the Regulation of Medical Devices Manufactured from or Incorporating Viable or Non-Viable Animal Tissue or their Derivative (s)
Date: 2004-07-12

Guidance for the Labelling of Medical Devices under Section 21 to 23 of the Medical Devices Regulations, Appendices for Labelling: Soft Contact Lenses and Menstrual Tampons
Date: 2004-06-12

Pre-Market Guidance on Bare Cardiovascular Stents
Date: 2004-04-28

Guidance for the Interpretation of Significant Change V.3
Date: 2003-03-20

Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Applications
Date: 2001-02-05

Preparation of an Application for Investigational Testing - Medical Devices V.3
Date: 1999-02-22

Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices (IVDD) V.3
Date: 1999-02-22

Guidance for the Interpretation of Sections 28 to 31: Licence Application Type
Date: 1999-01-12

Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications V.2
Date: 1998-10-23

Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices
Date: 2002-05-07

Guidance for the Labelling of In Vitro Diagnostic Devices - DRAFT
Date: 1998-06-24

Guidance for the risk based classification system - DRAFT
Date: 1998-05-04

Guidance for the risk based classification system of in vitro diagnostic devices - DRAFT
Date: 1998-04-24

Medical Devices Global Harmonization Task Force

Notice - Release of Proposed GHTF Guidance
Date: 2008-08-15

Guidance for Manufacturers Preparing a Premarket Application Using the Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices
Date: 2003-10-02

Notice to Industry - Pilot Premarket Review Program for Medical Devices
Date: 2001-12-10