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