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Buying Red & Infrared Light Therapy in Canada: Health Canada Rules, Duties, and What to Check First
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Wellness
5 min read

Buying Red & Infrared Light Therapy in Canada: Health Canada Rules, Duties, and What to Check First

K

Ken Pham

September 7, 2026

Interest in at-home red and near-infrared light therapy has grown quickly across Canada, but most of the category's marketing, reviews, and comparison content is written for a US audience — by US-based companies, shipping from US warehouses, regulated under FDA rules alone. If you're shopping from Canada, a few things work differently, and they're worth understanding before you buy.

Person using a Lufalight red and near-infrared light therapy panel at home in Canada

Health Canada vs. FDA: Two Separate Systems

The FDA regulates devices sold in the US. Health Canada regulates devices sold in Canada, and it runs its own licensing system — separate paperwork, separate review, separate rules. A device can be properly registered with the FDA and have no Health Canada standing at all, which matters if you're a Canadian buyer assuming "FDA" covers you.

For a general wellness light therapy device, the relevant Health Canada credential is a Medical Device License (MDL). It's reasonable to ask any company selling into Canada whether they hold one, and for what device class.

What MDSAP Actually Solves

You'll sometimes see "MDSAP" mentioned on a product page. The Medical Device Single Audit Program is one audit, recognized by multiple regulators at once — including both the FDA and Health Canada, along with several other countries.

The Part Most Reviews Don't Mention: Cross-Border Duties and Returns

  • Duties and brokerage fees can apply at the border, sometimes assessed after checkout.

  • Warranty service across the border often means shipping the device back to the US, at your cost.

  • Returns frequently work the same way: a cross-border return shipment.

  • Support hours are set to a US time zone.

Why a Canada-Based Company Changes the Math

Lufalight is built and operated as a Canadian company shipping to both Canada and the US, specifically so Canadian buyers don't run into the friction above.

Every Lufalight device carries the certification set relevant to both markets — FDA registration, a Health Canada Medical Device License (MDL), MDSAP, ISO 13485, and FCC compliance.

A Quick Checklist Before You Buy

  1. Do you hold a Health Canada Medical Device License (MDL), and for which device class?

  2. Where does the device ship from, and where does a return or warranty claim ship to?

  3. What's the actual warranty term, in writing?

  4. Is pricing shown in CAD with duties already accounted for?

  5. Is the company transparent about general wellness vs. medical claims?

This article is for general informational purposes and is not legal or regulatory advice. Lufalight devices are FDA-registered general wellness devices, not intended to diagnose, treat, cure, or prevent any disease.