Health Canada MDEL Licence #28664 — CPAP Machines Canada

Introduction

When you buy CPAP equipment online, you are buying a regulated medical device — not a consumer gadget. In Canada, any company that imports or distributes medical devices is legally required to hold a Medical Device Establishment Licence (MDEL) issued by Health Canada. CPAP Machines Canada holds one. Our licence number is 28664, and it authorizes us to import and distribute Class I, II, and III medical devices across the country.

We have chosen to publish this page openly because the MDEL is one of the clearest ways to tell a properly regulated supplier apart from a general online retailer. Many sites that sell CPAP machines, masks, and accessories operate without one. This page explains what an MDEL is, what ours specifically authorizes, what it does and does not mean, and — importantly — how you can verify it yourself directly on Health Canada's website in under a minute.

What Is a Medical Device Establishment Licence (MDEL)?

An MDEL is a licence issued by Health Canada under the Medical Devices Regulations of the Food and Drugs Act. It is required for any business that imports or distributes medical devices in Canada, regardless of the device class. In plain terms, it is the federal government's permission for a company to legally bring medical devices into the country and supply them to Canadians.

Crucially, an MDEL is about the establishment — the company and its procedures — rather than any single product. To hold one, a company must attest to Health Canada that it has formal, documented procedures in place for things like handling complaints, managing recalls, reporting incidents, and keeping distribution records. The licence is Health Canada's assurance that the business is set up to act responsibly if a safety problem with a device is ever identified.

An MDEL must be renewed every year. It is not a one-time certificate that a company earns and forgets — it is an ongoing commitment that Health Canada can review, and can suspend or cancel if a company fails to maintain the required procedures.

Our Licence at a Glance

Licensed Addresses

What Our MDEL Authorizes

Our licence authorizes us as both an importer and a distributor of medical devices in three device classes. Device classes in Canada run from Class I (lowest risk, such as a basic CPAP filter) up to Class IV (highest risk). CPAP machines and most CPAP accessories fall within Classes I to II, well inside our licensed scope.

We are licensed as an importer and distributor — not as a device manufacturer. That is the normal and correct licence type for a supplier that sources equipment from established manufacturers such as ResMed, Philips, Transcend, and others, and delivers it to Canadian patients.

The Procedures We Are Required to Maintain

An MDEL is not just a registration. To hold ours, we attested to Health Canada that we have documented procedures in place across several areas that exist to protect you after a device leaves our hands. These include:

• Distribution records — so that if a device is ever recalled, we can identify and contact everyone who received it.
• Complaint handling — a formal process for receiving, recording, and acting on customer complaints about a device.
• Recalls — procedures to carry out a recall quickly and effectively if a manufacturer or Health Canada issues one.
• Incident reporting — reporting problems and adverse events to the appropriate parties as required.
• Serious risk of injury — procedures for situations that present a serious risk to human health.
• Corrective action — a documented way to fix problems and prevent them from recurring.
• Installation and handling, storage, and delivery — procedures to keep devices safe and intact from our facility to your door.

These are exactly the safeguards that an unlicensed retailer is not held accountable for. When something goes wrong with a medical device, these procedures are the difference between a coordinated, traceable response and no response at all.

What an MDEL Does — and Doesn't — Mean

We want to be precise here, because this is where a lot of online sellers either misunderstand or overstate things. An MDEL licenses us as an establishment. It is Health Canada's confirmation that our company is authorized to import and distribute devices and has the required safety procedures in place.

An MDEL is not an approval of any individual product. Health Canada does not keep a list of specific devices under an MDEL, and holding one does not mean any particular machine is "Health Canada approved." Individual higher-risk devices (Classes II, III, and IV) are licensed separately through a Medical Device Licence (MDL), and those product licences appear in Health Canada's Medical Devices Active Licence Listing (MDALL).

We mention this distinction openly because it is the honest, accurate way to describe what our licence is. A supplier who tells you an MDEL means their products are individually government-approved is, at best, not reading the regulations carefully.

Why This Matters When You Buy CPAP Equipment

CPAP therapy is prescribed treatment for a medical condition. The equipment delivering that therapy should come from a supplier the federal regulator actually recognizes and holds accountable. An MDEL gives you several concrete protections that a general e-commerce store cannot offer:

• Recall reach. If a device you bought is recalled, our distribution records mean we can find you and act. An unlicensed seller has no obligation to track this.
• A real complaint channel. Problems with a device go into a documented, regulated process — not into a void.
• Accountability to a regulator. Health Canada can review, and if necessary suspend or cancel, the licence of a company that fails to meet its obligations. That oversight does not exist for sellers operating outside the framework.
• Legitimate supply chain. Importing under an MDEL means equipment enters Canada through the proper regulatory channel, not through grey-market routes.

Put simply, the MDEL is the reason we can stand behind the equipment we sell in a way that is backed by federal regulation rather than just a return policy.

How to Verify Our Licence Yourself

You do not have to take our word for any of this. Health Canada publishes a public, searchable listing of every active MDEL. You can look ours up directly and confirm the licence number, company name, addresses, authorized activities, and device classes shown on this page.

To verify our MDEL:

• Open Health Canada's Medical Devices Establishment Licence (MDEL) Listing.
• Search by our licence number 28664, our company ID 186448, or the company name CPAP Machines Canada (or FPM Solutions).
• Confirm the licence is listed as active. Only active MDELs appear in the listing.

Verify Our Licence on Health Canada →

Frequently Asked Questions