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: 44 with a channel role (importer, distributor, wholesaler or authorised representative), 29 registration holders without a channel role, and 31 registered as manufacturer or exporter only, out of 2,745 medical device establishments in Canada overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 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 20 in-vitro diagnostics establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | BTNX Inc. Pickering Ontario, ON | Channel 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 | Channel Importer, Registration holder, Manufacturer | Ear, nose and throat, In-vitro diagnostics | 74 | 68 | 0 | 58.8 | 3/5 |
| 3 | AMD Medicom Inc. Pointe-Claire, Montreal Quebec, QC | Channel Importer, Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +5 more | 83 | 32 | 0 | 58.1 | 3/5 |
| 4 | O-TWO MEDICAL TECHNOLOGIES, INC. Brampton Ontario, ON | Channel Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 89 | 29 | 0 | 58.0 | 3/5 |
| 5 | Philips Electronics Ltd. Mississauga Ontario, Ontario | Channel Importer, Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 573 | 2 | 0 | 54.3 | 3/5 |
| 6 | SOUTHMEDIC, INC. BARRIE Ontario, ON | Channel Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +4 more | 55 | 27 | 0 | 54.3 | 3/5 |
| 7 | BIOMEDICA DIAGNOSTICS INC. Windsor Nova Scotia, NS | Channel Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 29 | 30 | 0 | 50.4 | 3/5 |
| 8 | RESPONSE BIOMEDICAL CORPORATION Vancouver British Columbia, BC | Channel Importer, Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 45 | 17 | 0 | 50.0 | 3/5 |
| 9 | Merit Medical Canada Ltd. Markham Ontario, Ontario | Channel Importer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 266 | 2 | 0 | 48.8 | 3/5 |
| 10 | TRIBE MEDICAL GROUP London Ontario, Ontario | Channel Importer, Exporter | Cardiovascular, General hospital and consumables, Dental +5 more | 223 | 2 | 0 | 47.9 | 3/5 |
| 11 | INNOVATEK MEDICAL INC. Delta, BC | Channel Importer, Distributor, Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology | 40 | 19 | 0 | 47.7 | 3/5 |
| 12 | BIO NUCLEAR DIAGNOSTICS, INC. TORONTO Ontario, ON | Channel Importer, Distributor, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, In-vitro diagnostics +1 more | 19 | 13 | 0 | 46.8 | 3/5 |
| 13 | Canadian Hospital Specialties Ltd. MISSISSAUGA Ontario, Ontario | Channel Importer, Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 60 | 4 | 0 | 46.6 | 3/5 |
| 14 | KARL STORZ ENDOSCOPY CANADA LTD. Mississauga Ontario, Ontario | Channel Importer, Distributor, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +6 more | 111 | 2 | 0 | 46.0 | 3/5 |
| 15 | INNOPEX LIMITED Toronto Ontario, Ontario | Channel Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 139 | 2 | 0 | 45.5 | 3/5 |
| 16 | Terumo Medical Canada, Inc. Vaughan Ontario, Ontario | Channel Importer, Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +4 more | 128 | 2 | 0 | 45.1 | 3/5 |
| 17 | Medline Canada Corporation NORTH VANCOUVER British Columbia, Ontario | Channel Importer, Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 59 | 3 | 0 | 44.2 | 3/5 |
| 18 | AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP Brampton Ontario, Ontario | Channel Importer, Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 56 | 2 | 0 | 43.8 | 3/5 |
| 19 | KASH SALES INC. Richmond Hill Ontario, Ontario | Channel Importer, Distributor, Exporter | General hospital and consumables, Dental, In-vitro diagnostics +1 more | 71 | 2 | 0 | 43.8 | 3/5 |
| 20 | K.M. Medical & Trading Inc North York Ontario, Ontario | Channel Distributor, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 85 | 2 | 0 | 43.1 | 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 44 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada 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 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 76 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
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.