Medical Devices

Consultation

Information Sessions

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

Forms

• How to Submit a Consumer Complaint
• How to Submit a Trade Complaint
• Mandatory Problem Reporting for Medical Devices:
  • Preliminary Report Form (FRM-0237)
  • Final Report Form (FRM-0238)
  • Preliminary and Final Report Form (FRM-0255)
• Problem Reporting for Medical Devices - User Problem Report Form (FRM-0029)

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

• Medical Device Establishment Licence: Calculation Chart [2012-12-12]
• Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097)
• Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) [2012-12-12]
• Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) [2012-12-12]

Medical Device Product Licences Issued

• Medical Devices Active Licence Listing

Inspection Programme

Guidance

• Guide to Recalls of Medical Devices (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
• User Problem Reporting for Medical Devices (GUI-0060)

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)
  • Quality System Framework - Summary

Medical Devices

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