Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) are the licenses issued by Health Canada, the Health Agency regulating the medical devices marketed in the Canadian market. The medical devices are classified into 4 classes – Class I, II, III and IV in the Canadian market.
Medical Device Licences (MDL) are issued to devices falling in Classes II, III and IV and the Medical Device Establishment Licences (MDEL) are issued to manufacture the Class I devices. Additionally, MDEL is also issued to importers and distributors of all device classes – Class I, II, III and IV.
What are the requirements for issuing an MDEL?
The importers and distributors of Class I devices shall have written procedures for complaint handling and device recalls toobtain an MDEL. The manufacturers of Class I devices can import their product without an MDEL in place, provided the importers and distributors have a valid MDEL.
What are the requirements for issuing an MDL?
The manufacturers shall comply with Medical Device Regulations (MDR) of Health Canada, to obtain a MDL. The MDSAP certificate issued by Health Canada authorized Conformity Assessment Bodies (CAB) is a pre-requisite to apply for an MDL. There are different application forms for Class II, III and IV devices. The private labelers can apply for MDL only after the original manufacturer is issued an MDL. The application form for the private labelers is different from that of the original manufacturers.
Renewal of MDEL and MDL
The MDEL is subjected to annual review before April 1st of every year and the MDL for all device Classes are subjected to renewal before November 1st of every year. The application for renewal of MDL Licence is also different from the original Licence application.
Choosing the right application is critical to avoid any delays in application assessment by Health Canada. Freyr has expertise and experience in handling and delivering the Canadian Medical Device Regulatory projects. Reach out at firstname.lastname@example.org for assistance.