List of medical devices for exceptional importation and sale

Medical devices included on the list for exceptional importation and sale are called "designated medical devices". They are eligible for exceptional importation and sale as per sections 62.27 to 62.32 of the Medical Devices Regulations. This list is incorporated by reference in these regulations. Health Canada maintains and updates this list as required.

Designated medical devices are eligible for exceptional importation into Canada before the date listed in the "Last date for import" column. Products cannot be exceptionally imported after this date, but products already imported may be sold until their expiry dates, if applicable, or for 2 years after the date listed in the "Last date for import" column.

Date issued: 2022-09-22
Supersedes: 2022-08-31

Access archived versions of this list.

List of Medical Devices for Exceptional Importation and Sale
Medical Device Medical Device Category Name of Manufacturer MDEL/MDL number Name of Regulatory Agency authorizing device Last Date for import
Vacuum Assisted Venous Drainage Controller (VAVD) II Boehringer Laboratories, LLC MDEL 72 U.S. Food and Drug Administration
Australia TGA
Japan MHLW
2023-09-30
Epidural Needle (AN-E) II Zhejiang Runqiang Medical Instruments Co., Ltd. MDEL 13800 EU-CE Mark 2023-01-30
Spinal Needle (AN-S II) II Zhejiang Runqiang Medical Instruments Co., Ltd. MDEL 13800 EU-CE Mark 2023-01-30
Epidural Anaesthesia Kit (AS-E) II Zhejiang Runqiang Medical Instruments Co., Ltd. MDEL 13796 EU-CE Mark 2023-01-30
Champak N95 Respirator F550 I Champak Enterprise Co., Ltd. MDEL 13227 U.S. Food and Drug Administration 2023-01-01
Positive Airway Pressure Device (Model CA720) II Guangzhou Hypnus Healthcare Co., Ltd. MDEL 20464 Guangdong Food and Drug
Administration
People's Republic of China
2022-12-01
Positive Airway Pressure Device (Model BA725) II Guangzhou Hypnus Healthcare Co., Ltd. MDEL 20464 Guangdong Food and Drug
Administration
People's Republic of China
2022-12-01
Positive Airway Pressure Device (Model ST730) II Guangzhou Hypnus Healthcare Co., Ltd. MDEL 20464 Guangdong Food and Drug
Administration
People's Republic of China
2022-12-01
Dentech Thoracic Chest Drainage System (Dune model #10113) II Redax S.p.A MDEL 72 Ministry of Health, Italy 2022-12-21
Dentech Thoracic Chest Drainage System (Variant model #10112) II Redax S.p.A MDEL 72 Ministry of Health, Italy 2022-12-21
P-Eggy Chest Drain Valve (Model #10808) II Redax S.p.A MDEL 72 Ministry of Health, Italy 2022-12-21
CPAP device (model: Vivo 1) II Breas Medical AB MDEL 340 European Commission, Sweden 2022-12-01
CPAP device (model: Vivo 2) II Breas Medical AB MDEL 340 European Commission, Sweden 2022-12-01
CPAP device (model: Vivo 3) II Breas Medical AB MDEL 340 European Commission, Sweden 2022-12-01
iBreeze CPAP System (model 20A) II Resvent Medical Technology Co., Ltd. MDEL 19863 U.S. Food and Drug Administration 2022-12-01
Disposable Nitrile Examination gloves (Blue; Size XXL) II Blue Sail Medical Co. Ltd. MDEL 4507 Health Canada 2022-10-31
Disposable 3-ply non-woven medical face mask with ear loops I Hubei Qianjiang Kingphar Medical Material Co. Ltd. MDEL 12291 N/A 2022-03-02
Disposable Medical Face Mask I Sunsmed Protective Products Ltd. MDEL 726 N/A 2022-03-02
Fluid Resistant 4-ply Procedure Mask I Lam Khang General Joint Stock Company MDEL 6279 N/A 2022-03-02
Isolation Gown I Showing Polymer Limited MDEL 11721 N/A 2022-03-02
McKesson Powder-Free Nitrile Exam Gloves, Confiderm 3.5C II Hartalega NGC Sdn Bhd MDEL 4063 Health Canada 2022-03-02
Medical Grade Face Masks I V&Q Manufacturing Corporation MDEL 9174 N/A 2022-03-02
N95 Respirators I Makrite Industries Inc. MDEL 11593 N/A 2022-03-02
Non-Woven Face Masks I Shenzhen Delong Huale Electronic Co. Ltd MDEL 2332 N/A 2022-03-02
Non-Woven Face Masks I Xiantao Xingrong Protective Products Co., Ltd. MDEL 2332 N/A 2022-03-02
Non-Woven Isolation Gown I Zibo Minghui Logo Clothing Co., Ltd. MDEL 12291 N/A 2022-03-02
Powder Free Nitrile Examination Gloves (Blue Color) II Shijiazhuang Hongray Group Co. Ltd. MDEL 11585 Health Canada 2022-03-02
Champak N95 Respirator F550 I Champak Enterprise Co., Ltd. MDEL 13227 N/A 2022-03-02
Disposable CPE isolation gown I Shandong Housewares Manufacturing Co., Ltd. MDEL 12586 N/A 2022-03-02
Anesthesia Kit (AS-E) II Zhejiang Runqiang Medical Instruments Co., Ltd. MDEL 13800 EU-CE Mark 2023-01-30
iBreeze CPAP System (Model 20A) II Resvent Medical Technology Co., Ltd. MDEL 14912 U.S. Food and Drug Administration 2022-12-01
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