Who holds medical device registrations in Canada

Who may hold a registration in Canada

Health Canada issues the medical device licence for class II, III and IV devices to the device manufacturer, wherever it is based. This page lists the licence holders with an address in Canada; foreign manufacturers that hold Canadian licences are counted under their own country.

Sources: Health Canada, Guidance on how to complete the application for a new medical device licence.

Medical device licence holders in Canada: top 50

Ranked by active Health Canada licences. Each name opens its profile with roles, principals and sources.

1. 1
   CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHSOakville, ON
   113 registrationsManufacturer
2. 2
   BTNX Inc.Pickering, Ontario
   94 registrationsMaker's own entity
3. 3
   LOK QUALIT INC.Laval, QC
   74 registrationsManufacturer
4. 4
   CITEST DIAGNOSTICS INC.Vancouver British Columbia, BC
   66 registrationsMaker's own entity
5. 5
   THERMOR LTD.Newmarket, Ontario
   59 registrationsMaker's own entity
6. 6
   ARTRON LABORATORIES INC.Burnaby British Columbia, BC
   59 registrationsManufacturer
7. 7
   LUVO MEDICAL TECHNOLOGIES, INC.Cambridge, Ontario
   56 registrationsManufacturer
8. 8
   DIAGNOSTICS BIOCHEM CANADA, INC.London, Ontario
   54 registrationsManufacturer
9. 9
   ZOOMCO PRODUITS MEDICAUX PERSONNALISES OPÉRANT AUSSI SOUS LE NOM DE ZOOMCO PMP/CMPSaint-Jerome, QC
   50 registrationsMaker's own entity
10. 10
    SHOPPERS DRUG MART/PHARMAPRIXToronto, ON
    49 registrationsMaker's own entity
11. 11
    LABEX CANADA INCNewmarket, ON
    46 registrationsMaker's own entity
12. 12
    Sekisui Diagnostics P.E.I. Inc.Charlottetown Prince Edward Island, PE
    45 registrationsManufacturer
13. 13
    8083851 CANADA INC. OPERATING AS PAMA MANUFACTURING & STERILIZATIONMirabel, QC
    44 registrationsMaker's own entity
14. 14
    AMG MEDICAL INC.Montreal Quebec, QC
    41 registrationsMaker's own entity
15. 15
    NTBIO DIAGNOSTICS INC.Surrey, BC
    40 registrationsManufacturer
16. 16
    SALIENT MEDICAL SOLUTIONS INC.Toronto, ON
    39 registrationsMaker's own entity
17. 17
    KEGO CORPORATIONLondon, Ontario
    35 registrationsMaker's own entity
18. 18
    DERMA SCIENCES CANADA, INC.Toronto, Ontario
    35 registrationsMaker's own entity
19. 19
    CONAIR CONSUMER PRODUCTS ULCWoodbridge, ON
    35 registrationsManufacturer
20. 20
    MCKESSON CANADA CORPORATION / LA CORPORATION MCKESSON CANADASaint-Laurent, QC
    34 registrationsMaker's own entity
21. 21
    THOUGHT TECHNOLOGY LTD.Montreal Quebec, QC
    32 registrationsMaker's own entity
22. 22
    AMD Medicom Inc.Pointe-Claire, Montreal Quebec, QC
    29 registrationsMaker's own entity
23. 23
    JAC-CELL MEDICMont - Royal Quebec, QC
    29 registrationsMaker's own entity
24. 24
    LE GROUPE JEAN COUTU (PJC) INC.Varennes, QC
    29 registrationsMaker's own entity
25. 25
    NIPRO CANADA CORPORATIONLindsay, Ontario
    28 registrationsMaker's own entity
26. 26
    BIOMEDICA DIAGNOSTICS INC.Windsor Nova Scotia, NS
    28 registrationsMaker's own entity
27. 27
    ENDOCH INC.Concord, ON
    28 registrationsMaker's own entity
28. 28
    O-TWO MEDICAL TECHNOLOGIES, INC.Brampton, Ontario
    27 registrationsMaker's own entity
29. 29
    DISTRIBUTION INSTRUMENTARIUM INC. DBA INSTRUMENTARIUMTerrebonne, QC
    27 registrationsMaker's own entity
30. 30
    SOUTHMEDIC, INC.Barrie, Ontario
    25 registrationsMaker's own entity
31. 31
    ATLAS MEDIC INC.St-Augustin-De-Desmaures, QC
    24 registrationsMaker's own entity
32. 32
    BEYES DENTAL INC.Toronto, Ontario
    24 registrationsManufacturer
33. 33
    WALMART CANADA CORP.Mississauga, ON
    23 registrationsManufacturer
34. 34
    BOMIMED INC.Winnipeg, Manitoba, MB
    22 registrationsMaker's own entity
35. 35
    NATUS MEDICAL INCORPORATED ADBA EXCEL-TECH LTD (XLTEK)Oakville, ON
    22 registrationsManufacturer
36. 36
    RHOING (1975) LIMITED OPERATING AS ALMEDICSt-Laurent, QC
    21 registrationsMaker's own entity
37. 37
    MANSFIELD MEDICAL DISTRIBUTORS LTD.Montreal, QC
    20 registrationsMaker's own entity
38. 38
    DOMREX PHARMA INC.Saint-Eustache, QC
    19 registrationsMaker's own entity
39. 39
    PULSE SCIENTIFIC INC.Burlington, ON
    19 registrationsMaker's own entity
40. 40
    TRUDELL MEDICAL INTERNATIONAL INC. ADBA TRUDELL MEDICAL INTERNATIONALLondon, ON
    19 registrationsManufacturer
41. 41
    DENTAL SAVINGS CLUB INC.Verdun Quebec, QC
    18 registrationsMaker's own entity
42. 42
    INNOVATEK MEDICAL INC.Delta, BC
    18 registrationsMaker's own entity
43. 43
    MAXILL, INC.St. Thomas, Ontario
    17 registrationsMaker's own entity
44. 44
    GLENKESIK MEDICAL LTD.Oakville, ON
    17 registrationsManufacturer
45. 45
    LABTICIAN OPHTHALMICS, INC.Oakville, Ontario
    16 registrationsMaker's own entity
46. 46
    REXALL PHARMACY GROUP LTD.Mississauga, ON
    16 registrationsManufacturer
47. 47
    RESPONSE BIOMEDICAL CORPORATIONVancouver British Columbia, BC
    15 registrationsMaker's own entity
48. 48
    RADION LABORATORIES LTD. DBA BOWERS MEDICAL SUPPLYDelta, BC
    15 registrationsMaker's own entity
49. 49
    Precision BioLogic Inc.Dartmouth Nova Scotia, NS
    15 registrationsManufacturer
50. 50
    SINCLAIR DENTAL CO. LTD.North Vancouver, BC
    15 registrationsManufacturer

Download all 195 company rows as CSV

Company level only: names that are only a person's name are left out; 348 rows whose only public registry is Health Canada stay on their profile pages, under Health Canada's terms.

How many holders also distribute

0 of the 543 holders listed here (0%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.

The others: 259 makers' own import or sales entities and 284 manufacturers.

See every independent distributor in Canada on the country page.

Medical device registration in Canada with CE or FDA clearance

With CE marking or FDA clearance: No reliance route on either one is confirmed in the source.

Health Canada licence for class II to IV with an MDSAP certificate; no reliance on CE or FDA decisions. Importers and distributors need an establishment licence.

Health Canada licenses class II devices on the manufacturer's attestation plus an MDSAP certificate; class III and IV get a full premarket review. Canadian class II maps roughly to EU class IIa.

No reliance on FDA decisions, but one MDSAP audit satisfies the quality system requirements of the participating regulators, the US FDA among them, so an FDA-compliant maker reuses its audit. Product review is still local.

Sources: Health Canada, Guidance on how to complete the application for a new medical device licence (MDSAP certificate required), Health Canada, Class II application content and classifications guidance, US FDA, Medical Device Single Audit Program (MDSAP). Confidence in this route: high, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.

How to check it yourself in the official register

Health Canada Medical Devices Active Licence Listing (MDALL). The active licence search filters by company name, licence name, device name, company ID and licence number.

The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.

What changes if you switch holder

The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.

Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable.

The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.

Next step

All guides

Sources

• Health Canada MDALL active licence listing and MDEL establishment licence listing: 543 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
• US FDA Establishment Registration and Device Listing, openFDA bulk download: 186 establishments, last seen 23 October 2026. US government work, public domain.
• UK MHRA Public Access Registration Database (PARD): 75 establishments, last seen 23 October 2026. Public register.

Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.