Compliance & Coverage
Understanding the Canadian regulatory landscape for hyperbaric oxygen therapy — from federal device classification to provincial health insurance coverage.
Health Canada MDALL Registry
Only these hard-shell hyperbaric chambers hold active Medical Device Licences from Health Canada. All are Class III devices requiring pre-market safety review.
Anaheim, California, USA
Licensed since January 1999. The most widely deployed chambers in Canadian hospital hyperbaric programs.
| Model | Since |
|---|---|
| 2500B | 1999 |
| 2500BR | 1999 |
| 3200 | 1999 |
| 3200R | 1999 |
| 2800 | 2000 |
| 2800R | 2000 |
Examples of common licensed models • Class III • See Health Canada MDALL for complete listing
Riviera Beach, Florida, USA
Licensed since January 2001. The Sigma series is used in hospital and private clinical settings across Canada.
| Model | Since |
|---|---|
| Sigma 34 | 2001 |
| Sigma 36 | 2009 |
| Sigma 40 | 2006 |
| Sigma Plus | 2021 |
4 models • Class III • Single-patient acrylic chambers
Hyperbaric Modular Systems, Inc.
San Diego, California, USA
Licensed since September 2008. The only multiplace (walk-in) chamber system licensed in Canada, treating up to 18 patients simultaneously.
| Model | Since |
|---|---|
| HMS 5000-12 / OxyHeal 5000-12 | 2022 |
| HMS 5000-18 / OxyHeal 5000-18 | 2022 |
| OxyControl System (HMI) | 2012 |
3 models • Class III • 12–18 patient walk-in chambers
Soft-Shell / Inflatable Chambers Are Not Licensed
Health Canada has not licensed any soft-shelled or inflatable hyperbaric chambers and has issued safety warnings against their use. These devices have not been evaluated for safety, quality, or effectiveness, and may pose serious risks including fire, barotrauma, and infection transmission. Only hard-shell chambers listed above hold valid Medical Device Licences.
Health Canada Safety Advisory →Source: Health Canada Medical Devices Active Licence Listing (MDALL) — Verified February 2026
Oxygen Standards
In Canada, medical oxygen is regulated as a drug. Not all oxygen is equal - purity, source, and regulatory compliance determine whether oxygen can legally be used for patient treatment.
Under the Food and Drug Regulations (CRC, c. 870), medical oxygen is classified as a drug and requires a Drug Identification Number (DIN) before it can legally be sold or used for human therapeutic purposes. This is the fundamental distinction between medical-grade and industrial oxygen in Canada - purity may be similar, but only DIN-bearing products are legal for medical use.
Under section C.01.011 of the Food and Drug Regulations, any drug sold in Canada must meet the highest purity standard set out in a Schedule B pharmacopeia. Schedule B incorporates the United States Pharmacopeia (USP), the British Pharmacopoeia, and the European Pharmacopoeia.
All manufacturers and suppliers of medical oxygen must comply with Health Canada's Good Manufacturing Practices for Medical Gases (GUI-0031), which requires oil-free production, quality control testing against USP specifications, certified containers, and traceable documentation.
| Category | Purity | DIN Required? | Legal for HBOT? |
|---|---|---|---|
| Medical Oxygen USP (cryogenic distillation) |
99.0%+ (typically 99.5%) |
Yes - required | Yes - standard for HBOT |
| Oxygen 93 USP (PSA/concentrator) |
90-96% (labelled as 93%) |
Possible if DIN obtained | Below CUHMA recommended standard - see below |
| Industrial/Welding Oxygen | 99.2-99.5% | No | No - illegal for patient use regardless of purity |
| Concentrator Output (without DIN) |
90-96% | No | No - not a regulated drug product |
The molecular composition of O2 is identical across all sources. What distinguishes medical from industrial oxygen is the regulatory chain: GMP-compliant manufacturing, traceable quality control testing, certified containers, and a DIN on every cylinder or bulk delivery document.
While Oxygen 93 USP is a pharmacopeia-recognised grade in Canada, the professional bodies that govern hyperbaric medicine set a higher bar for therapeutic HBOT:
The UHMS requires medical grade oxygen of 99.0%+ purity (USP or national equivalent) for therapeutic HBOT delivery. The UHMS explicitly opposes the use of oxygen concentrators in HBOT settings and has issued a position statement that low-pressure fabric chambers with concentrators "do not meet the minimum requirements in terms of exposure pressure, structural design, or safety."
CUHMA's Guidelines to the Practice of Clinical Hyperbaric Medicine emphasise continuous oxygen monitoring and oppose the use of pressures below 1.5 ATA or oxygen concentrations below 100% except in approved research settings. Health Canada's device licensing framework references the UHMS indications list when evaluating hyperbaric chamber applications.
What this means in practice: Even though Oxygen 93 USP is a legally recognised drug product in Canada, CUHMA guidelines recommend medical-grade Oxygen 99 USP for clinical HBOT programmes. A facility's choice of oxygen grade may be assessed against these professional standards in any regulatory, insurance, or liability proceeding.
No province independently sets an oxygen purity threshold beyond the federal DIN requirement. However, provincial medical regulatory colleges enforce compliance through accreditation:
The CPSO Out-of-Hospital Premises Inspection Program (OHPIP) requires that all medical compressed gases comply with CSA standards and hold valid Health Canada DINs. A facility using non-DIN oxygen would fail CPSO inspection.
The CPSA hyperbaric accreditation programme references CUHMA guidelines and CSA Z275.1. Accredited facilities must comply with Health Canada's DIN regime for all medical gases used.
Legitimate HBOT facilities in Canada source their medical oxygen from DIN-holding suppliers that comply with Health Canada's GMP requirements. Major suppliers include:
DIN status can be verified through the Health Canada Drug Product Database (DPD). When evaluating an HBOT facility, patients and referring physicians can ask to see the facility's oxygen supply documentation, including DIN verification and GMP compliance certificates.
Beware of Non-Compliant "Mild HBOT" Operations
Some businesses in Canada offer "mild hyperbaric oxygen therapy" using soft-shell inflatable chambers pressurised to 1.3-1.4 ATA with oxygen from portable concentrators (90-96% purity). These operations typically have no DIN for their oxygen supply, use unlicensed soft-shell chambers, operate at pressures the UHMS considers sub-therapeutic, and are not accredited by any provincial medical regulatory college. Health Canada has issued safety warnings about these devices.
Information compiled from publicly available regulatory documents, April 2026. Confirm specific requirements with your provincial regulatory college before making compliance decisions.