Health Canada MDEL Licence #33245
Health Canada MDEL Licence — Licence #33245
The Physio Store Inc. holds an active Medical Device Establishment Licence (MDEL) issued by Health Canada. We operate primarily as a licensed importer and distributor of medical devices in Canada, and we also act as a Class I manufacturer (private label) for our own brands.
What is a Medical Device Establishment Licence (MDEL)?
A Medical Device Establishment Licence (MDEL) is a company-level licence issued by Health Canada. It authorizes an establishment to import and/or sell (distribute) medical devices in Canada. MDELs are required for importers and distributors of medical devices, as well as Class I manufacturers, unless a specific exemption applies.
Holding an MDEL does not “approve” each individual product. Instead, it confirms that the establishment has the required quality and safety procedures in place and is subject to Health Canada oversight and enforcement.
Our role as an importer & distributor
As a Health Canada–licensed importer and distributor, The Physio Store Inc. manages the flow of medical devices from manufacturers to Canadian customers and clinics. This includes:
- Importing medical devices into Canada from approved manufacturing partners.
- Distributing devices to hospitals, clinics, therapists, and consumers across the country.
- Maintaining the records, complaint-handling processes, and recall procedures required by Health Canada.
When you buy from us, you are purchasing from a regulated establishment that is accountable to Health Canada—not an unknown third-party seller.
Our role as a Class I manufacturer (private label)
In addition to importing and distributing third-party products, we also act as a Class I manufacturer (private label) for our own brands CalorDerm and Strenkyo. These devices are manufactured in China with The Physio Store Inc. named as the manufacturer on the product label.
For these Class I products, our MDEL #33245 covers the licensable activities of importing and distributing our own labelled devices in Canada.
Why this licence matters to you
- Regulated supply chain: As a licensed importer and distributor, we must follow Canada’s Medical Devices Regulations for distribution records, complaint handling, and recalls.
- Health Canada oversight: MDEL holders can be inspected and monitored by Health Canada to confirm ongoing compliance.
- Traceability & recalls: We keep detailed distribution records so products can be traced and, if necessary, recalled quickly and efficiently.
- Extra assurance when buying online: You’re purchasing from a regulated Canadian establishment rather than an unlicensed reseller or grey-market importer.
What we are authorized to do under MDEL #33245
| Importing medical devices | We are authorized to import eligible medical devices into Canada and ensure they comply with Health Canada’s requirements before they are sold. |
|---|---|
| Distributing / selling devices | We distribute medical devices to clinics, hospitals, health-care professionals, and consumers across Canada, while maintaining records and procedures for complaints and recalls. |
| Class I manufacturing (private label) | For Class I devices sold under our brands CalorDerm and Strenkyo, we act as the manufacturer of record on the label. Our MDEL covers the import and distribution of these private-label products in Canada. |
How to verify our licence with Health Canada
You can verify our status at any time using Health Canada’s public Medical Device Establishment Licence Listing:
- Go to the official Health Canada MDEL search page.
- Search by Licence Number and enter 33245, or search by company name: The Physio Store Inc.
- Confirm the listing shows our licence number, company name, and authorized activities.
Frequently asked questions
Is an MDEL the same as an MDL?
No. An MDEL is an establishment licence that applies to companies such as importers, distributors, and Class I manufacturers. An MDL is a product licence for specific Class II, III, or IV medical devices.
Why is it important that you are a licensed importer and distributor?
Being a licensed importer and distributor means our activities are regulated by Health Canada. We must keep distribution records, manage complaints, and support recalls when needed. This provides greater safety, traceability, and accountability compared with buying from unlicensed or offshore sellers.
Do Class I devices need their own MDL?
Generally, Class I devices do not require an individual Medical Device Licence (MDL). Instead, the establishment that imports or distributes them must hold an MDEL and follow the associated requirements.
How do your roles as importer, distributor, and Class I manufacturer work together?
For some devices, we act as a licensed importer and distributor for other manufacturers. For our CalorDerm and Strenkyo Class I products, we are also the manufacturer of record. In all cases covered by our MDEL #33245, we follow the same regulated processes for records, complaints, and recalls.
Does holding an MDEL mean every product is “approved” by Health Canada?
Holding an MDEL means our establishment is authorized and regulated. Where required, individual Class II–IV devices are licensed separately under MDLs. Class I devices, like our CalorDerm and Strenkyo products, are overseen at the establishment level through our MDEL and Health Canada’s inspection program.
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