Canada Medical Device Licensing
Device classification, MDL and MDEL applications, bilingual labelling, and keeping the licence in good standing.
Medical devices sold in Canada are regulated by Health Canada under the Medical Devices Regulations, made under the Food and Drugs Act. Devices are sorted into four classes by risk, Class I being the lowest and Class IV the highest, and what you have to hold depends on both the class of the device and what your company does with it.
A Medical Device Licence (MDL) authorises a specific Class II, III or IV device; a Medical Device Establishment Licence (MDEL) authorises an importer, distributor, or Class I manufacturer instead. They are separate requirements, and many companies need both.
Medical Device Licensing Services
We can take on as much of the licensing process as you need:
Compliance strategy guidance
Our experts can identify the correct device class (Class I–IV), determine licensing requirements (i.e. MDL, MDEL), and devise a compliance plan that takes into account equivalency and predicate devices.
Medical Device Licence (MDL) applications
Our experts can assist in preparing and submitting Class II, III and IV medical device licence applications, including the required device information, intended use, labelling, safety and effectiveness documentation, and guidance on obtaining MDSAP/ISO 13485 quality management system certification. We can also coordinate responses to Health Canada review questions and requests for additional information during the application review.
Medical Device Establishment Licence (MDEL) applications
For importers and distributors, and for Class I manufacturers, we can assist with preparation of the Health Canada MDEL application and the documented procedures required under the Medical Devices Regulations — distribution records, complaint handling, recalls, and, where applicable, mandatory incident reporting.
Labelling and bilingual requirements
Device labelling in Canada must comply with the content, format and language requirements of sections 21–23 of the Medical Devices Regulations. We can review device labels, instructions for use and packaging against Canadian labelling requirements, including applicable English/French requirements, to support compliance before commercialization.
Licence maintenance
A licence is not a one-off. Device licences are subject to an annual renewal confirming the licence is still current, establishment licences are renewed annually as well, and establishments are subject to inspection. We track the renewal cycle, prepare the filings and help you prepare for inspection, so a licence is not lost to a missed date.
Change notifications and amendments
Changes to a licensed device — to its design, intended use, manufacturing, packaging or labelling — may require regulatory action. We can assess proposed changes against Health Canada’s requirements to determine whether they are significant or require a licence amendment, and assist in preparing the applicable documentation. Where a change is non-significant but requires updating previously submitted information, we can support the required documentation and annual-renewal reporting.
Request a quote
Contact us today to receive a quote. Tell us what the device does and where else it is approved — existing approvals often shorten the Canadian route considerably.
Northern Certification
30 Canterbury Pl, Suite 1607
North York, ON M2N 0B9
Canada
Email: info@northerncertification.com
Phone: +1-647-639-0083