Health Canada Class II Medical Device
Hale RLPRO panels are registered as Class II medical devices under the Medical Devices Regulations administered by Health Canada. This page summarizes what that classification means for procurement, what it covers, and how your compliance team can verify it.
What Class II covers
- Manufacturer compliance with ISO 13485 quality system requirements
- Adverse-event reporting and post-market surveillance obligations
- Establishment Licence held under the Food and Drugs Act
- Authorization to make clinical-use claims in Canada for the indicated wavelengths
Why this matters for procurement
Consumer-grade red light panels sold direct-to-consumer in Canada are typically not Class II registered. If your facility requires medical device classification for insurance reimbursement, occupational therapy plans, or regulated clinical use, the regulatory floor lives at Class II. Hale operates above that floor.
Verification path
Health Canada maintains a public Medical Devices Active Licence Listing (MDALL). Your compliance officer or procurement reviewer can verify the listing under the manufacturer name. We supply the full Establishment Licence and registration certificate scans as part of any procurement-grade RFP response — request them via the form on this page or by reply to your assigned account manager.
Where this fits
- Anchor document for any clinic deployment intake.
- Required attachment in any enterprise network procurement response.
- Paired with FDA Registration for U.S. cross-border buyers.
- Persona-specific context for chiropractors, physical therapists, and clinicians.
- Product-side: RLPRO 2000, RLPRO 1200, RLPRO 1000.