Guidance documents – Medical devices

Device Advice: e-Learning tool

• 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.

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

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Date modified: 2024-07-31