Updated 22 October 2026
In-vitro diagnostics distributors in Canada: 104 licensed establishments
The Bastion Hale Distributor Index lists 104 establishments in Canada whose registry records include in-vitro diagnostics: 3 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 41 manufacturers' own import or sales entities, 0 regulatory representatives, and 60 manufacturers or exporters, out of 2,768 medical device establishments in Canada overall. The records come from US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 38 | 37% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 27 | 26% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 50 | 48% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 90 | 87% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 37 | 36% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Canada
In Canada the device licence (MDALL) is held by the manufacturer, while importers and distributors need a Medical Device Establishment Licence (MDEL). The manufacturer keeps the product registration; the distributor's MDEL is its own and transfers nothing to it.
Top 3 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | TRIBE MEDICAL GROUP London Ontario, Ontario | Distributor Importer, Exporter | Cardiovascular, General hospital and consumables, Dental +5 more | 223 | 2 | 0 | 47.9 | 3/5 |
| 2 | INNOPEX LIMITED Toronto Ontario, Ontario | Distributor Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 139 | 2 | 0 | 45.5 | 3/5 |
| 3 | K.M. Medical & Trading Inc North York Ontario, Ontario | Distributor Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 85 | 2 | 0 | 43.1 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (101)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | BTNX Inc. Pickering Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology +1 more | 365 | 96 | 0 | 70.7 | 3/5 |
| 2 | CITEST DIAGNOSTICS INC. VANCOUVER British Columbia, BC | Maker's own entity Importer, Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 74 | 69 | 0 | 61.2 | 3/5 |
| 3 | AMD Medicom Inc. Pointe-Claire, Montreal Quebec, QC | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +5 more | 83 | 32 | 0 | 60.5 | 3/5 |
| 4 | BIOMEDICA DIAGNOSTICS INC. Windsor Nova Scotia, NS | Maker's own entity Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 29 | 30 | 0 | 50.4 | 3/5 |
| 5 | O-TWO MEDICAL TECHNOLOGIES, INC. Brampton Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 89 | 29 | 0 | 60.4 | 3/5 |
| 6 | SOUTHMEDIC, INC. BARRIE Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +4 more | 55 | 29 | 0 | 57.0 | 3/5 |
| 7 | INNOVATEK MEDICAL INC. Delta, BC | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 40 | 19 | 0 | 47.7 | 3/5 |
| 8 | RESPONSE BIOMEDICAL CORPORATION Vancouver British Columbia, BC | Maker's own entity Importer, Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 45 | 17 | 0 | 50.0 | 3/5 |
| 9 | BIO NUCLEAR DIAGNOSTICS, INC. TORONTO Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, In-vitro diagnostics +1 more | 19 | 13 | 0 | 46.8 | 3/5 |
| 10 | SOLUTIONS PROTEXIA INC. DBA. SECURMEDIC Montreal, QC | Maker's own entity Importer, Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology | 11 | 8 | 0 | 36.5 | 3/5 |
| 11 | Medisca Pharmaceutique Inc. St-Laurent Quebec, QC | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 13 | 7 | 0 | 42.4 | 3/5 |
| 12 | BLAY SCIENTIFIC CANADA, LTD Coquitlam, BC | Maker's own entity Importer, Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 5 | 6 | 0 | 31.8 | 3/5 |
| 13 | SCICAN LTD. TORONTO Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, In-vitro diagnostics | 11 | 5 | 0 | 42.6 | 3/5 |
| 14 | CEDARLANE CORPORATION BURLINGTON Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 3 | 5 | 0 | 36.1 | 3/5 |
| 15 | SCIENTIFIC SUPPLIES CENTRE Winnipeg, MB | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 6 | 5 | 0 | 33.1 | 3/5 |
| 16 | Canadian Hospital Specialties Ltd. MISSISSAUGA Ontario, Ontario | Maker's own entity Importer, Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 60 | 4 | 0 | 49.0 | 3/5 |
| 17 | THE BIRD AND BE CO. INC. Toronto Ontario, ON | Maker's own entity Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 3 | 4 | 0 | 31.5 | 3/5 |
| 18 | Medline Canada Corporation NORTH VANCOUVER British Columbia, Ontario | Maker's own entity Importer, Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 59 | 3 | 0 | 44.2 | 3/5 |
| 19 | DNA GENOTEK, INC. Ottawa Ontario, Ontario | Maker's own entity Importer, Manufacturer | General hospital and consumables, In-vitro diagnostics | 17 | 3 | 0 | 38.9 | 3/5 |
| 20 | GERMIPHENE CORPORATION BRANTFORD Ontario, ON | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics | 3 | 3 | 0 | 31.7 | 3/5 |
Questions about in-vitro diagnostics distributors in Canada
How many in-vitro diagnostics distributors are there in Canada?
The Index counts 104 establishments in Canada with in-vitro diagnostics in their registry record, of which 3 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in Canada?
In Canada the device licence (MDALL) is held by the manufacturer, while importers and distributors need a Medical Device Establishment Licence (MDEL). The manufacturer keeps the product registration; the distributor's MDEL is its own and transfers nothing to it.
How do I find a in-vitro diagnostics distributor in Canada?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Canada to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics distributor in Canada?
A company that appears in a public regulatory registry with an address in Canada and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Canada
In-vitro diagnostics in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 84 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 76 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 22 establishments, last seen 23 October 2026. Public register.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.