Class I medical devices require only a Medical Device Establishment Licence (MDEL), while class II, III, and IV medical devices require a Medical Device Licence (MDL) and an MDEL. For Class II devices, you only need to attest that your device meets the regulatory requirements for your device, however must be able to demonstrate that you can meet the requirements you attested to during an inspection by Health Canada. For Class III and IV devices, however, you are required to submit safety and efficacy data to Health Canada. Class II, III, and IV medical devices are also required to be certified ISO 13485 under the Medical Device Single Audit Program (MDSAP).
What is an MDL and an MDEL?
A medical device licence (MDL) is a licence that is required for companies that import, sell, or distribute Class II, III, or IV medical devices in Canada.
A medical device establishment licence (MDEL) is a licence that is required for any company that imports, sells, or distributes any class of medical device in Canada.
dicentra offers the following services to help prepare you for your MDEL or MDL registration:
- Medical device classification
- Preparation of Medical Device Licence (MDL) applications
- Preparation of Medical Device Establishment (MDEL) applications
- MDEL renewals
- MDL & MDEL amendments
- Quality System design and development to meet Canadian requirements
- SOP & PnP preparation and review
Contact our medical device specialists using the form below for support with your MDL and MDEL registrations.