Compliance and enforcement of medical devices - Forms, guidance, policies and laws

Forms

• Recall reporting for medical devices:
  • Medical device initial recall reporting form (FRM-0360A)
  • Medical device final recall reporting form (FRM-0360B)
• Complaint reporting for medical devices:
  • Medical device complaint
  • Reporting complaints about health products
• Mandatory problem reporting for medical devices:
  • Preliminary Report Form (FRM-0237)
  • Final Report Form (FRM-0238)
  • Preliminary and Final Report Form (FRM-0255)

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)
• Archive 1: Guidance on Risk Classification of Medical Device Observations (GUI-0079)
• Guidance on Medical Device Establishment Licensing (GUI-0016) [2020-04-01]
• Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices - Canada.ca
• Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097)
• How Health Canada inspects medical device establishments (GUI-0064) [2016-11-17]
• Guidance on Medical Device Compliance and Enforcement (GUI-0073) - Canada.ca
• Guide to reporting medical device shortages and discontinuations (GUI-0137)

Policies

• Compliance and Enforcement Policy (POL-0001)
• Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)

Laws and regulation

• Criminal Code (justice.gc.ca)
• Fees in Respect of Drugs and Medical Devices Order (justice.gc.ca)
• Food and Drugs Act (justice.gc.ca)
• Medical Devices Regulations (justice.gc.ca)

Medical devices

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