Medical Device Establishment Licence: Everything You Need to Know
Entering Canada’s medical device market comes with strict regulatory requirements. One of the most important steps for manufacturers, distributors, and importers is securing a Medical Device Establishment Licence (MDEL). Without this licence, businesses cannot legally sell medical devices in Canada.

What is a Medical Device Establishment Licence?

A Medical Device Establishment Licence is issued by Health Canada to companies that import or distribute medical devices. It confirms that your business complies with Canadian regulations and has procedures in place for safety, recalls, and complaint handling.

Companies that typically require an MDEL include:

Importers of medical devices

Distributors of medical devices

Manufacturers that sell devices made by another company under their name

Why is an MDEL Important?

An MDEL is more than just paperwork—it ensures:

Legal compliance: Your business meets Health Canada’s regulatory standards.

Market access: Without it, you cannot legally sell or distribute devices in Canada.

Consumer safety: The licence demonstrates accountability for quality, complaints, and recalls.

Credibility: Pharmacies, clinics, and partners often require proof of compliance before doing business.

Steps to Obtain a Medical Device Establishment Licence

Determine if you need an MDEL – Not all companies require one. For example, manufacturers selling only their own Class I devices may be exempt.

Prepare your quality system procedures – This includes recall handling, complaint procedures, and distribution records.

Complete the MDEL application – Submit required details to Health Canada, including company information, device classes, and roles.

Pay the application fee – Fees vary depending on your business.

Maintain compliance – Once approved, you must renew the licence annually and keep your procedures up to date.

Common Mistakes Businesses Make

Misunderstanding whether an MDEL is required

Submitting incomplete applications

Failing to maintain procedures for recalls and complaints

Missing annual licence renewal deadlines

These mistakes can lead to application rejections, enforcement actions, or even loss of market access.

How Quality Smart Solutions Can Help

Navigating the MDEL process can be complex. At Quality Smart Solutions, our experts:

Assess if your business requires an MDEL

Prepare and review your application for compliance

Assist with developing recall and complaint handling procedures

Support with renewals and post-licence compliance

Conclusion

A Medical Device Establishment Licence is critical for businesses that want to sell medical devices in Canada. It ensures compliance, protects consumers, and opens the door to market opportunities. With the right guidance, the application process can be smooth and stress-free.

Partner with Quality Smart Solutions today to secure your MDEL and bring your medical devices to the Canadian market with confidence.