The following may be useful as Helpful links. MedMate bears no responsibility for the information contained within these links and websites:
Health Canada rules on medical devices:
canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
Recalls and Safety alerts:
recalls-rappels.canada.ca/en
Medical device active license search:
health-products.canada.ca/mdall-limh/prepareSearch?type=active
Medical Device shortages in Canada:
canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/list.html
MDEL search:
health-products.canada.ca/mdel-leim/index-eng.jsp
Risk Based Classification of Medical Devices:
canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html#a31
MDSAP Canada:
canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html
Helpful points taken from Health Canada’s website:
- Health Canada does not maintain a list of products (for example, the specific medical devices) under an MDEL.
- The MDEL does not constitute approval of any specific medical devices imported or distributed by the MDEL holder.
- Only importation and distribution are licensable activities under an MDEL, including for Class I manufacturers.
- A medical device establishment licence (MDEL) is issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.
- MDALL = Medical Devices Active Licence Listing
- MDEL= Medical Device Establishment Licence
- MDL= Medical Device Licence
