Guidance documents – Medical devices

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.

• Good Guidance Practices
• Fees for Medical Devices
• Medical Devices Guidance Documents
• Medical Devices Global Harmonization Task Force
• Regulatory enrolment process

COVID-19

• Medical devices for use in relation to COVID-19 [2023-02-22]
• Guidance on applications for COVID-19 medical device clinical trials under the Regulations
• Applications for medical device clinical trials under the Interim Order: Guidance document
• Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak – Guidance to industry
• Important regulatory considerations for the supply of medical gowns – Guidance to Industry
• Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document

Fees for Medical Devices

For fee-related guidance documents and forms, please visit Fees for Medical Devices.

• Notice: Guidance Document Updates to Reflect New Fees and Policies for April 1, 2020

Medical Devices Guidance Documents

• Guidance on Medical devices for an urgent public health need [2024-01-03]
• Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10]
• The Health Canada eSTAR pilot program [2023-01-10]
• Guidance on clinical evidence requirements for medical devices [2022-11-15]
• Guide to reporting medical device shortages and discontinuations [2022-03-02]
• Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device [2020-04-01]
• Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document [2020-03-26]
• Guidance Document - Management of Application for Medical Device Licenses [2019-11-04]
• Guidance Document Software as a Medical Device (SaMD): Definition and Classification [2019-12-18]
• Guidance Document Software as a Medical Device (SaMD): Classification Examples [2019-12-18]
• Overview of the Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals [2019-06-26]
• Pre-market Requirements for Medical Device Cybersecurity [2019-06-26]
• Draft Health Canada IMDRF table of contents for medical device applications guidance [2019-02-28]
• Implementation of Advance Notice of Importation Process for Medical Devices [2019-02-12]
• Guidance on Advance Notice of Importation under section 21.1 of the Medical Devices Regulations (MDR) and section 3.1 of the Radiation Emitting Devices Regulations (REDR) [2019-02-12]
• Consultation on Draft Guidance Document – Pre-market Requirements for Medical Device Cybersecurity [2018-12-07]
• Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to Information Requirements [2018-10-01]
• Guidance document: Applications for Medical Device Investigational Testing Authorizations – Changes to Information Requirements [2018-10-01]
• Notice: Changes to Evidence in Requirements for Class II and Class III Infusions Pumps [2018-08-13]
• Guidance Document: Safety and Effectiveness Requirements for Contact Lens Disinfectants (2018) [2018-01-26]
• Guidance Document: Safety and Effectiveness Requirements for High-Level Disinfectants and Sterilants for use on Reusable Semi-Critical and Critical Medical Devices (2018) [2018-01-26]
• Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care of for Self-Testing [2017-10-20]
• Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations [2017-10-06]
• Guidance Document: Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers [2017-01-16]
• Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) [2016-09-26]
• Notice: Use of FDA Guidance Materials to support Canadian Medical Devices Licence Applications [2016-08-04]
• Guidance Document: Labelling of In Vitro Diagnostic Devices [2016-04-22]
• Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices [2016-02-18]
• Amendments to the Food and Drugs Act Guide to New Authorities [2015-07-31]
• Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities - What We Heard [2015-07-31]
• Updated Guidance Document: Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices - Appendices for the Labelling of Soft Contact Lenses, Decorative Contact Lenses, and Menstrual Tampons [2015-07-29]
• Publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices, and the Release of related Final Guidance Documents and Application Forms [2015-07-29]
• Guidance Document - How to Complete the Application for a New Medical Device Licence [2018-01-26]
• Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs) [2015-06-12]
• Guidance Document – Fees for the Review of Medical Device Licence Applications [2019-11-04]
• Guidance Document – Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices [2019-11-04]
• Guidance for Industry: Device Licence Applications for Ultrasound Diagnostic Systems and Transducers [2013-09-13]
• Guidance Document: 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) [2012-07-05]
• Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence [2011-12-15]
• Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory [2011-12-07]
• Guidance for the Interpretation of Significant Change of a Medical Device [2011-06-03]
• Guidance Document: Information to be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices [2011-06-01]
• Private Label Medical Devices: Questions and Answers [2011-03-29]
• Application for a New Medical Device Licence for a Private Label Medical Device [2011-03-29]
• Guidance Document - Private Label Medical Devices [2011-03-15]
• Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [2010-10-26]
• Bis(2-ethyhexyl) phthalate (DEHP) and Bisphenol A (BPA) - Questions & Answers [2008-08-15]
• E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories [2008-07-29]
• Guidance Document: Submission of Pharmacogenomic Information [2008-05-23]
• Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards [2008-03-17]
• Bed-related Entrapment and Fall Report Form [2008-03-17]
• Notice: Updated Guidance on the Recognition and Use Of Standards under the Medical Devices Regulations [2006-09-22]
• Guidance Document: Recognition and Use of Standards under the Medical Device Regulations [2006-09-22 ]
• Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices [2006-09-14]
• Application for a Medical Device Licence Amendment for a Private Label Medical Device [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) [2004-07-12]
• Pre-Market Guidance on Bare Cardiovascular Stents [2004-04-28]
• Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices [2002-05-07]
• Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Applications [2001-02-05]
• Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices (IVDD) V.3 [1999-02-22]
• Guidance for the Interpretation of Sections 28 to 31: Licence Application Type [1999-01-12]

Medical Devices Global Harmonization Task Force

• Guidance Document: Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers [2010-05-31]

Regulatory enrolment process

• Regulatory enrolment process