COVID-19 Medical Device Establishment Licence (MDEL) suspensions

Health Canada issues Medical Device Establishment Licences (MDELs) to:

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:

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:

If you are responsible for purchasing COVID-19-related medical devices at the wholesale level, you must confirm that the:

The Department will be updating this list regularly, so please check it frequently.

List of Medical Device Establishment Licence (MDEL) suspensions
MDEL holder Company Name Address Activity Reason for suspension Date
15161 ZHEJIANG BAIYI INTELLIGENT GARMENT CO., LTD No.1 Fengshan 1 Road,
Industrial Park Hangbu Town, Kecheng District,
Quzhou, Zhejiang, 324014, China
Class I – Manufacturer Repeated lack of response to Health Canada's requests for information 2021-06-04
11854 DISTRIBUTION CROSS PACIFIQUE GLOBAL INC. 42 Rue De Darvault
Candiac, QC, J5R 6X4
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
14367 9406-1348 QUEBEC INC. Suite 340, 3700 Rue Griffith,
Montreal, QC, H4T 2B3
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
12031 LES IMPORTATIONS N ET N INC. 109 D’Amsterdam,
St-Augustin de Demaures, QC, G3A 2V5
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
11975 SERVICE SMART MEDIC INC. 290 13e Avenue
Richelieu, QC, J3L 3T7
257 Sherbrooke Est, Suite 400, Montreal, QC, H2X 1E3
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
12085 PARKSIDE THERAPY 520 Curran Place
Mississauga, ON, L5B 0J4
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
11690 11756974 CANADA CORP. 6020 Yonge Street
Toronto, ON, M2M 3V9
Class I - Importer Lack of distribution records; Lack of recall and complaint handling procedures 2021-05-13
14086 2719535 Ontario Inc. 39 Adastra Crescent
Markham, ON, L6C 3G7
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
14282 CONSOLIDATED GROUP OF COMPANIES CANADA INC. 77 Belfield Road,
Toronto, ON, M9W 1G6
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
14306 NAPPE CORP 2206 Kenneth Crescent,
Burlington, ON, L7L 6T4
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
14363 MEDI SUPPLIES PLUS INC. 47 Rockview Gardens,
Concord, ON, L4K 2J4
Class I - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
14543 SANTÉ ET SOLIDARITÉ INTERNATIONALE 390 King Street, Suite 11,
Fredericton, NB, E3B 1E3
Class I, II, III - Importer Repeated lack of response to Health Canada's requests for information 2021-05-13
14444 MARKKIT INTERNATIONAL TRADING LTD. 60 Walter Havill Drive, Suite 312,Halifax, NS B3N 0A9 Class I - Importer 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 - Importer Lack of recall and complaint handling procedures 2021-03-05
14185 MULTILINK CANADA 96 Macewan Park Rise NW, Calgary, AB, T3K 4A1 Class I - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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, Kensington, 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 - Importer Lack of recall and complaint handling procedures 2021-03-05
11935 FANA SPORTS INC. 6140 Rue Marivaux, Montreal, QC, H1P 3K3 Class I - Importer 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 - Importer 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 - Importer 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 - Importer Lack of recall and complaint handling procedures 2021-03-05
12492 ATTRACTION INC. 672, rue du Parc, Lac-Drolet, QC, G0Y 1C0 Class I - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer Repeated lack of response to Health Canada's requests for information 2021-01-29
13620 THE RGM GROUP HOLDING INC 920 Yonge Street, Suite 608, Toronto, ON, M4W 3C7, Class I - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer 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 - Importer Repeated lack of response to Health Canada's requests for information 2021-04-06
13547 GROUPE PLP CONSULTANTS INC. DBA PHARMA LIFE PRO 1200 Rue Du Petit Bois,
Longueuil, QC J4N 1S1
Class I, II - Importer Lack of recall and complaint handling procedures 2021-06-04
12244 ABC TECHNOLOGIES MEDICAL DEVICES INC. 2 Norelco Drive, Toronto, ON M9L 2X6 Class I - Manufacturer Lack of distribution records; Lack of recall and complaint handling procedures 2021-06-04
14797 DRAGON ASIA HK LTD. 99 Zhongtan Road, Building 57, Room 1608, Shanghai, 020-Shanghai, China, 20061 Class I - Manufacturer and Distributor Repeated lack of response to Health Canada's requests for information 2021-06-04
14821 OUTPAC DESIGNS, INC. DBA PACSAFE 300 Lenora Street, Suite 1627, Seattle, WA, USA 98121-2411 Class I - Distributor Repeated lack of response to Health Canada's requests for information 2021-06-04
12335 CANADIAN PPE SAFETY SUPPLY 12825 144 Street,
Edmonton, AB T5L 4N7
Class I,II - Importer and Distributor Repeated lack of response to Health Canada's requests for information 2021-07-16
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