HHZ Respiratory Review

Health Canada licences for CPAP and oxygen devices

2 min read By HHZ Editorial Next review

Health Canada licenses Class II, III and IV medical devices and lists them in its Medical Devices Active Licence Listing (MDALL); only products in that listing may be offered for general marketing in Canada. CPAP machines, masks and oxygen concentrators we checked are all Class II, for example the ResMed AirSense 11 (licence 106650) and Inogen Rove 6 (licence 109185).

This guide is written from Health Canada’s MDALL page, and from licence records retrieved from Health Canada’s medical devices database on 14 October 2026. It is not legal advice.

How licensing works

Health Canada licenses medical devices under the Food and Drugs Act and the Medical Devices Regulations. It says:

  • MDALL lists all licensed Class II, III and IV medical devices offered for sale in Canada.
  • Class I devices don’t need a medical device licence. They are monitored through establishment licensing.
  • Only products in the listing may be offered for general marketing in Canada.
  • You can search by company name, licence name or number, device name or device identifier (often the catalogue number).
DeviceLicenceClassFirst licensedLicence holder
ResMed AirSense 11 (AutoSet, CPAP, Elite)106650II7 Sep 2021ResMed Pty Ltd (Australia)
ResMed AirSense 10 AutoSet93717II12 Aug 2014ResMed Pty Ltd
ResMed AirMini99052II26 Apr 2017ResMed Pty Ltd
ResMed AirFit F40111649II12 Aug 2024ResMed Pty Ltd
Inogen Rove 6109185II11 Apr 2023Inogen, Inc. (US)
Inogen Rove 4111230II14 May 2024Inogen, Inc.
Philips SimplyGo Mini95321II30 Jul 2015Philips Respironics
CAIRE FreeStyle Comfort101643II21 Aug 2018CAIRE
Yuwell oxygen concentrator111620II8 Aug 2024Yuwell
F&P Nova Micro110189II5 Mar 2024Fisher & Paykel

Dates are the first licence date for each device in the record.

Checking before you buy

  1. Search MDALL for the exact model name.
  2. Check the licence has no end date. For example, one Evora nasal mask record under licence 67268 ended on 28 March 2023, while newer Evora records under the same licence remain active.
  3. For connected machines, Canadian CPAP Store points out that its AirSense 11 is ResMed’s Canadian model, with a cellular connection certified for use in Canada. A model bought abroad may differ.

For prices on licensed devices, see CPAP machine prices and portable oxygen concentrators.

Frequently asked questions

What is MDALL?
Health Canada’s Medical Devices Active Licence Listing, a database of all licensed Class II, III and IV medical devices offered for sale in Canada.
What class is a CPAP machine in Canada?
The ResMed AirSense 10, AirSense 11 and AirMini licences we checked are all Class II.
Do Class I devices need a licence?
No. Health Canada says Class I devices don’t need a medical device licence; they are monitored through establishment licensing.

CPAP machine prices in Canada (2026)

Live CAD prices for CPAP machines at Canadian retailers: ResMed AirSense 11 and 10, AirMini and AirCurve 11 VAuto bilevel, plus rental and the Health Canada licence check.

Portable oxygen concentrators in Canada (2026)

CAD prices for portable oxygen concentrators at Canadian retailers: Inogen Rove 6, Philips SimplyGo Mini, CAIRE FreeStyle Comfort and Eclipse 5, with licence numbers.

CPAP mask prices in Canada (2026)

CAD prices for ResMed, Fisher & Paykel and Philips CPAP masks at Canadian retailers, by mask type, with the funding gap: Ontario ADP does not pay for replacement masks.

Flying with CPAP or oxygen from Canada

Air Canada and WestJet rules for CPAP and portable oxygen concentrators: 48-hour notice, medical clearance, battery limits, Air Canada oxygen fees, and 120 V power in Canada.