Compliance and enforcement of medical devices - Forms, guidance, policies and laws
Forms
- Recall reporting for medical devices:
- Complaint reporting for medical devices:
- Mandatory problem reporting for medical devices:
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
Laws and regulation
Medical devices
Page details
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