COVID-19 Medical Device Establishment Licence (MDEL) suspensions
Health Canada issues Medical Device Establishment Licences (MDELs) to:
- companies that import, distribute or manufacture Class I devices, such as masks, respirators, eye protection, gowns and swabs
- importers and distributors of Class II, III and IV devices, such as gloves, ventilators and testing devices
The demand for medical devices during the COVID-19 pandemic is unprecedented. To help meet the demand, in March 2020, Health Canada began expediting the issuance of Medical Device Establishment Licences (MDELs) to facilitate access to COVID-19-related devices. When applying for an MDEL, an applicant must attest to having certain critical procedures in place at their establishment. These procedures ensure that companies with an MDEL can:
- respond appropriately to complaints about the devices that they sell
- recall a device if necessary
- maintain records of the devices they sell so they can inform their clients about a recall
Complying with the requirements for these procedures is critical to ensuring there is a safe supply of COVID-19-related medical devices for Canadians. Failure to comply with regulatory requirements poses a risk to the health and safety of Canadians.
As of April 2020, Health Canada has been conducting remote assessments of MDEL holders for COVID-19-related devices and requesting proof of their recall and complaint handling procedures as well as distribution records.
Establishments that do not respond to Health Canada's requests or provide the requested documents will have their MDEL suspended.
The suspension takes effect immediately. It prohibits the establishment from conducting any licensable activities.
If a risk to health is identified with any medical device, Health Canada will:
- inform Canadians through a recall or public advisory
- give direction on what to do with the product
If you are responsible for purchasing COVID-19-related medical devices at the wholesale level, you must confirm that the:
- manufacturer, importer or distributor of the devices holds an MDEL, and
- the MDEL holder does not appear in the list of suspended MDELs
The Department will be updating this list regularly, so please check it frequently.
| MDEL holder | Company Name | Address | Activity | Reason for suspension | Date |
|---|---|---|---|---|---|
| 14444 | MARKKIT INTERNATIONAL TRADING LTD. | 60 Walter Havill Drive, Suite 312,Halifax, NS B3N 0A9 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 11815 | FIRETECH MANUFACTURING LTD. | 3525 191St Street, Surrey, BC, V3Z 0P6 | Class I - Manufacturer | Lack of recall and complaint handling procedures | 2021-03-05 |
| 13810 | Abdullah Jasser DBA Jasser Enterprise Ltd | 5236 Aerial Cresent, Regina, SK, R4W 0C8 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 14185 | MULTILINK CANADA | 96 Macewan Park Rise NW, Calgary, AB, T3K 4A1 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 14794 | MGA COMMODITIES INC | 88 Boulevard Brunswick, Dollard-des-Ormeaux, QC, H9B 2C5 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 11621 | LES HABITATION GUANG SHA CANADA INC. | 1310 Grande-Allee, Carignan, QC, J3L 3P9 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 13275 | MASEAT | 277 South Park Road, Scarborough, ON, L3T 0B7 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 13949 | 8577471 CANADA INC. | 4155 Boulevard de Maisonneuve Ouest, Westmount, QC, H3Z 1K3 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 14764 | AB SAFETY APPAREL | 15011 118 Avenue North West, Edmonton, AB, T5V 1H9 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 11952 | IES ENERGY SALES INC. | 10721 Saskatchewan Drive, Edmonton, AB, T6E 6J5 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 12050 | TOUT UN SAC/MY GREEN BAG | 2746 Chemin Bellerive, Carignan, QC, J3L 4K2 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 13966 | MAINETTI CANADA | 1211 MONTÉE DE LIESSE, Saint-Laurent, QC, H4S 1J7 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 13974 | 7290179 CANADA INC. DBA ANNICK LEVESQUE ACCESSOIRES | 138 Laurier Ouest, Montreal, QC, H2T 2N7 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 12898 | LITERIE FINE BIGARADE INC. | 3743 Rue Sainte-Catherine Est, Montréal, QC, H1W 2E9 | Class I - Manufacturer | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 13377 | SAFETY PRO INC. | Kensington Enterprise Centre, 5 Gerald McCarville Drive, Kensignton, PE, C0B 1M0 | Class I - Manufacturer | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 11583 | SUNBRIDGE TRADING INC. | 200 Rue de Gaspe, SUITE 1109, Montreal, QC, H3E 2E6 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 11935 | FANA SPORTS INC. | 6140 Rue Marivaux, Montreal, QC, H1P 3K3 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 12950 | SCANMEG INC. | 3517 Boulevard de la Grande Allée, Boisbrand, QC, J7H 1H5 | Class I - Manufacturer | Lack of recall and complaint handling procedures | 2021-03-05 |
| 13186 | ALL-STATE GLOBAL MEDICAL SUPPLIES | 81 B Back Cove Road, BOX 949, Spainard’s Bay, NL, A0A 3X0 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-03-05 |
| 13717 | NEPTON INC. | 81 B Back Cove Road, BOX 949, Spainard’s Bay, NL, A0A 3X0 | Class I - Manufacturer | Lack of recall and complaint handling procedures | 2021-03-05 |
| 14464 | TOBEQ TOOLS & EQUIPMENT INC. | 976 Rue Bergar, Laval, QC, H7L 5A1 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 11755 | CANADIAN MEDICAL DEVICE TRADE CENTER LTD | 6 Rue Dagobert, Candiac, QC, J5R 5Y9 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 12492 | ATTRACTION INC. | 672, rue du Parc, Lac-Drolet, QC, G0Y 1C0 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-05 |
| 12886 | CARSON HEALTH, INC. | 212 McCaul Street, Unit 2 Toronto, ON, M5T 1W5 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-27 |
| 12902 | 2731102 ONTARIO INC. DBA G&M SALES | 10 Sandway Drive Brampton, ON, L7A 2H5 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-27 |
| 13083 | 2319375 ONTARIO LTD. | 80 Simpson Road, Bolton, ON, L7E 4G2 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-27 |
| 13101 | 10377350 CANADA INC. | 1460 The Queensway, Suite 010, Etobicoke, ON, M8Z 1S4 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-27 |
| 13808 | JIA-E CORP. | 85 Cherrywood Winnipeg, MB, R3Y 0S8 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-27 |
| 13048 | DÉPÔT RAKUN | 2305 Boulevard Napoléon, Brossard, QC, J4Y 1Y5 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 12315 | QUINSTELLA INC. | 1254 Napier Crescent, Oakville, ON, L6Y 2A4 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 13687 | JEXWIN INTERNATIONAL INC | 63 Triangle Villas Drive, Scarborough, ON, M1W 3L1 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 12760 | 9371-7692 QUEBEC INC. | 204 Notre-Dame Street West, Suite 150, Montreal, QC, H2Y 1T3 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 13198 | 2253725 ALBERTA LTD | 617 20th Street West, Saskatoon, SK, S7M 0X8 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 12088 | PRO LINE SPORTS LIMITED | 14 Water Street, Windsor, NS, B0N 2T0 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 12241 | 9696563 CANADA INC. DBA ASPIRE MEDIA GROUP INC. | 410 Rue Saint Nicolas, Suite 600, Montreal, QC, H2Y 2P5 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 13406 | ICOOL CANADA INC. | 1055 West Georgia Street, Vancouver, BC, V6E 4N7 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 13483 | 2451592 ONTARIO INC. | 172 Tower Hill Road, Richmond Hill, ON, L4E 4T3 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 14141 | PISIM TRADING CORPORATION | English River, Saskatoon, SK, S7L 1C8 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-29 |
| 13143 | PEACE COLLECTIVE INC | 6350 Viscount Road, Mississauga, ON, L4H 2C1 | Class I - Importation Class I - Distribution |
Repeated lack of response to Health Canada's requests for information | 2021-02-01 |
| 13620 | THE RGM GROUP HOLDING INC | 920 Yonge Street, Suite 608, Toronto, ON, M4W 3C7, | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-01-20 |
| 14002 | 12014670 CANADA INC | 1750 Avenue Pierre-Péladeau, Laval, QC, H7T 2Z1 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-01 |
| 12709 | JAMMILAH DIXON-KEATING (PURE SANITATION COMPANY) | Psc Building 0, North York, ON, M3K 0A4 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-04 |
| 12503 | GROUPE DISTRIBUTION DULAC INC. | 178 Rue du Verdier, Levis, QC, G6K 1L4 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-04 |
| 12478 | 9226-9810 QUÉBEC INC | 230 Notre Dame, Lavaltrie, QC, J5T 1K1 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-04 |
| 14017 | 9371 - 8740 QUEBEC INC. | 6235 Rue Corbeil, Trois Riviere, QC, G8Z 4P8 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-04 |
| 13106 | MB OIL & LOGISTICS COMPANY | 19 White Ash Drive, Brandon, MB, R7A 7T1 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-05 |
| 13978 | 3D MEDICAL SUPPLY LTD. | Suite 2445 10180, Edmonton, AB, T5J 3S4 |
Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-05 |
| 14855 | EDEN TEXTILES LTD. | 10934-120Th Street NW, Edmonton, AB, T5H 3P7 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-05 |
| 13276 | 9058 3170 QC INC DBA PLEBUS GROUP | Entrepôt, 2405 Rue Royale, Trois-Rivières, QC, G9A 4L6 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-02-08 |
| 12124 | GOHAN TRADING INC. | 563 Ebury Place Delta, BC, V3M 6M8 | Class I - Importation | Lack of recall and complaint handling procedures | 2021-03-15 |
| 12355 | APRO INTERNATIONAL TRADING INC | Lansdowne Centre, 5300 No 3 Road Unit 210, Richmond, BC, V6X 2X9 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
| 12480 | 1182519 B.C. LTD DBA L&D INVESTMENT CONSULTING LTD. | 16823 18 Avenue, Surrey, BC, V3Z 9X3 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
| 13123 | AXIS PROTOTYPES INC. | 6956 Jarry Street East, Saint-Leonard, QC, H1P 3C1 | Class I - Manufacturer and Distributor | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
| 13818 | Central One Holdings Inc. | 110 West Beaver Creek Road, Suite 9, Richmond Hill, ON, L4B 1J9 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
| 13830 | Venture Solutions | 8 Noble Oaks Court, King, ON, L7B 0N3 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
| 13862 | SHOPCOVID19.ORG | 1641 Spruce Drive, Caledon, ON, L7K 1B1 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
| 13994 | Twenty Twenty PPE Inc. | 360 Bay Street, Suite 999, Toronto, ON, M5H 2V6 | Class I - Importation | Repeated lack of response to Health Canada's requests for information | 2021-04-06 |
Report a problem or mistake on this page
- Date modified: