Dell Tech guides companies through Health Canada’s medical device licensing process. We assist with classification, documentation, and submission of Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) applications to ensure your devices meet all Canadian regulatory and quality system requirements.
We help you determine the appropriate risk-based classification for your device and prepare your Health Canada application accordingly. From Class I to Class IV, we support both private label and original product submissions.
Medical devices sold in Canada must be licensed based on their classification. Class I devices require an MDEL, while Class II, III, and IV devices require a Medical Device Licence and a Canadian importer that holds an MDEL. In addition, Class II and above require MDSAP-certified quality systems. Labeling, packaging, and marketing materials must also comply with Health Canada’s expectations and language requirements.
Dell Tech reviews your device type, marketing claims, and intended use to determine exactly what is required and how to move forward.
We’ve been working with Health Canada for over 45 years. Our submissions are trusted, complete, and well-formatted to avoid unnecessary delays.
Incorrect classification is one of the top reasons for delayed approvals. We carefully analyze your product’s claims, function, and use to determine the correct device class the first time.
Our team bridges the gap between regulatory licensing and quality assurance, so your Class II to IV submission strategy supports long-term compliance and audit success.
We ensure your medical device labels, IFUs, and promotional materials meet Canadian language and content standards in both English and French.
Yes. Class II, III, and IV devices require a Medical Device Licence issued by Health Canada. Class I devices do not require a device licence, but the company selling them must hold a valid MDEL.
An MDEL is for establishments that import or distribute Class I to IV devices, and for foreign manufacturers of Class I devices A Medical Device Licence is specific to the product and required for Class II, III, and IV devices. Dell Tech helps determine which one applies to your business.
The Medical Device Single Audit Program (MDSAP) is mandatory for Class II and higher medical device applications in Canada. It is a Health Canada-recognized l quality standard that evaluates your QMS against ISO 13485 and other jurisdictional standards.
Timelines vary by device class. Class II devices are often reviewed within 60 business days, while Class III and IV submissions may take longer depending on complexity. Dell Tech ensures your submission is complete and minimizes review delays.
Yes. We regularly assist with private label licensing and cross-referencing. We help ensure the legal manufacturer and private labeler are both represented correctly in the application and labeling.
Yes. Labels, IFUs, and packaging must be available in both English and French. Dell Tech reviews and formats documentation to ensure compliance with language requirements under Canadian law.
Whether you are preparing to launch a new device in Canada or need support maintaining compliance for an existing product, Dell Tech can help. Contact us today to get started.
