Medical Devices
Consultation
Information Sessions
- Medical Device Program Information Sessions [2011-05-20]
Forms
- Recall Reporting for Medical Devices:
- Health Product Complaint Form (FRM-0317)
- Mandatory Problem Reporting for Medical Devices:
Public Warning / Advisories
Problem Reporting
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
Inspection Programme
Guidance
Recalls
Guidance Documents, Directives and Policies
Medical Devices
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