Global Medical Device Consulting – Registration Services
Medical Device Registration in Canada
| Medical Device Licence (MDL) | Medical Device Establishment Licence (MDEL) | |
| Regulatory Authority | Health Canada | Health Canada |
| Device Class | Classes II, III and IV | Manufacturing the Class I devices, and Importers and Distributors of all classes Class I, II, III and IV. |
| Applicant | Foreign manufacturer | Foreign manufacturer and/or importer/distributor |
| Time frame | Class II 15 days, Class III 60 days; Class IV 75 days | 120 Calendar days |
What are MDL and MDEL?
The MDL (approval licence) is an approval of the device, while the MDEL (factory license) is a permit given to the manufacturer/distributor/importer company.
The foreign medical device (class I) manufacturer who intends to sell their medical devices directly to the user in Canada must obtain an MDEL. The manufacturer who intends to sell to the importer on-site must obtain it if he/she is not already in possession of it.
Class II, III and IV medical device manufacturers will also need to prove that they have a certified ISO 13485 quality management system under the Medical Device Single Audit Program (MDSAP).