Medical Devices

Consultation

• Summary Report: Stakeholder Consultation Workbook for the Medical Devices Inspection Cycle [2013-01-11]

Information Sessions

• Medical Device Program Information Sessions [2011-05-20]

Forms

• Recall Reporting for Medical Devices:
  • Medical device initial recall reporting form (FRM-0360)[2016-11-03]
  • Medical device final recall reporting form (FRM-0360)[2016-11-03]
• Health Product Complaint Form (FRM-0317)
  • Summary
  • Questions and Answers
• Mandatory Problem Reporting for Medical Devices:
  • Preliminary Report Form (FRM-0237)
  • Final Report Form (FRM-0238)
  • Preliminary and Final Report Form (FRM-0255)

Public Warning / Advisories

• Procedure - The Release to the Public of Information Obtained from Adverse Reaction and Medical Device Reports
• Advisories and Warnings
  • Advisories, Warnings and Recalls

Problem Reporting

• Adverse Reaction Information

Establishment Licences

• Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097)
• Guidance on Medical Device Establishment Licensing (GUI-0016) [2020-04-01]
• Medical Device Establishment Licence (MDEL) application: Instructions (FRM-0292) [2020-04-01 ]
• Frequently Ask Questions (FAQ's) - Medical Device Establishment Licensing and Fees [Updated 2020-04-01]
• Fees for the Review of Medical Device Establishment Licence Applications

Medical Device Product Licences Issued

• Medical Devices Active Licence Listing

Inspection Programme

• Summary of the Results of the Medical Devices Inspection Program From 2004-2009
• How Health Canada inspects medical device establishments (GUI-0064) [2016-11-17]

Guidance

• Medical devices recall guide (GUI-0054)
• Guidance on Investigation of Reported Medical Device Problems (GUI-0065)
• Guidance on Risk Classification of Medical Device Observations (GUI-0079)
• Mandatory Problem Reporting for Medical Devices

Recalls

• Recalls
• Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)
• Product Recall Procedures

Guidance Documents, Directives and Policies

• Guidance Documents, Directives and Policies
  • Compliance and Enforcement Policy (POL-0001)
  • Consultation: Draft Documents for Medical Devices Program
  • Guidance on Medical Device Compliance and Enforcement (GUI-0073) [2015-06-12]

Medical Devices

• Visit the Medical Devices section for more documents and information on medical devices