Guidance documents on medical devices

Access guidance documents on the classification of medical devices:

• Guidance document: Classification of products at the drug-medical device interface [2021-07-22]
• 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]
• Guidance document: Guidance for the risk-based classification system for in vitro diagnostic devices (IVDDs) [2016-09-26]
• Guidance document: Guidance on the risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) [2015-06-12]
• Keyword index to assist manufacturers in verifying the class of medical devices [2006-09-14]

Access guidance documents and notices on medical device licensing and authorization:

• Device licence applications for diagnostic ultrasound systems and transducers: Notice to industry [2026-01-19]
• Health Canada IMDRF table of contents for medical device applications guidance [2025-11-25]
• Guidance on managing applications for medical device licences [2025-11-21]
• Guidance for determining medical device application type [2025-08-29]
• The eSTAR pilot: Notice to industry [2025-08-19]
• Medical devices contained in electronic health record (EHR) products: Notice to industry [2022-10-11]
• Guidance document: How to complete the application for a new medical device licence [2021-03-22]
• Guidance document: Management of application for medical device licenses [2019-11-04]
• Notice: Use of FDA guidance materials to support Canadian medical devices licence applications [2016-08-04]
• Notice to industry: Licensing requirements for inter-dependent medical devices [2002-05-07]

Find information and guidance documents on quality systems and the Medical Device Single Audit Program (MDSAP):

• Quality systems ISO 13485
• Health Canada and MDSAP
• Medical Device Single Audit Program (MDSAP)

Access guidance documents and notices on safety and effectiveness evidence requirements:

• Medical masks and respirators: Information for manufacturers [2025-06-29]
• Pre-market guidance for machine learning-enabled medical devices [2025-02-05]
  • Transparency for machine learning-enabled medical devices: Guiding principles [2024-06-13]
  • Predetermined change control plans for machine learning-enabled medical devices: Guiding principles [2023-10-24]
  • Good machine learning practice for medical device development: Guiding principles [2021-10-27]
• Guidance on using standards to support compliance with the Medical Devices Regulations [2025-01-27]
• Guidance on terms and conditions for class II to IV medical devices [2024-12-18]
• Guidance on clinical evidence requirements for medical devices [2022-11-15]
• Risk of thermal harm from therapeutic and cosmetic energy-based medical devices: Notice to industry [2020-08-21]
• Guidance document: Supporting evidence for implantable medical devices manufactured by 3D printing [2019-04-30]
• Pre-market requirements for medical device cybersecurity [2019-06-26]
• Notice: Changes to evidence in requirements for class II and class III infusions pumps [2018-08-13]
• Guidance document: Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices [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]
• Guidance document: Preparation of premarket medical device licence and licence amendment applications for dermal fillers [2017-01-16]
• Guidance document: Labelling of in vitro diagnostic devices [2016-04-22]
• 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]
• Guidance for manufacturers of human immunodeficiency virus (HIV) test kits intended to be used in the laboratory [2011-12-07]
• Guidance document: Medical device applications for implantable cardiac leads [2011-10-25]
• 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]
• Guidance document on the regulation of medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivatives [2004-07-12]
• Pre-market guidance on bare cardiovascular stents [2004-04-28]
• Draft guidance document on HIV simple and rapid test kits [1997]

Learn about the regulatory enrolment process (REP) for filing medical device licence applications:

• Regulatory enrolment process

Find fee-related guidance documents and forms for medical devices:

• Fees for medical devices
• Notice: Guidance document updates to reflect new fees and policies for April 1, 2020

Access guidance documents on private label medical devices:

• Guidance document: How to complete the application for a new medical device licence or licence amendment for a private label medical device [2020-04-01]
• 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]
• Application for a medical device licence amendment for a private label medical device [2005-06-01]

Access guidance documents and notices on clinical trials and the Special Access Program (SAP):

• Guidance on applications for COVID-19 medical device clinical trials under the Regulations [2022-03-02]
• Health Canada's special access programs: Request access to a medical device [2020-10-20]
• Guidance document: Applications for medical device investigational testing authorizations [2018-10-01]
• Notice: Applications for medical device investigational testing authorizations – Changes to the timing of research ethics board (REB) approval [2018-10-01]
• Guidance for health care professionals on special access and custom-made medical devices [2016-02-18]
• Preparation of an application for investigational testing - in vitro diagnostic devices (IVDD) V.3 [1999-02-22]

Find guidance documents related to reporting adverse reactions or side effects and other information on risk communications:

• Reports and publications - MedEffect Canada

Access guidance documents on post-market requirements:

• Guidance on summary reports and issue-related analyses for medical devices [2021-06-23]
• Foreign risk notification for medical devices guidance document [2021-06-23]
• Adult hospital beds: Patient entrapment hazards, side rail latching reliability, and other hazards [2008-03-17]

Find compliance program guidance documents and forms, including establishment licensing:

• Compliance and enforcement of medical devices - Forms, guidance, policies and laws
• Directives, guidance documents and policies - Establishment licences - Drugs and health products

Find information on medical device shortages, including how to report shortages and discontinuations:

• Medical device shortages

Access guidance documents on medical device shortages and discontinuations:

• Guide to reporting medical device shortages and discontinuations [2022-03-02]

Access guidance documents on reporting medical device incidents:

• Incident reporting for medical devices: Guidance document [2021-06-23]
• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals [2019-06-26]

To report a problem with a medical device, visit:

• Report a medical device problem
• Report a medical device incident: industry
• Report a medical device incident: hospitals
• Report a medical device problem: consumers

Access other guidance documents related to medical devices:

• Guidance on medical devices for an urgent public health need [2024-01-03]
• 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]
• Guidance document on public release of clinical information [2019-03-12]
• 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]