ARCHIVED 3. List of medical devices for exceptional importation and sale [2023-02-14 to 2023-03-05]
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: 2023-02-14
Supersedes: 2023-01-31
Access archived versions of this list.
| Medical Device | Medical Device Category | Name of Manufacturer | MDEL/MDL number | Name of Regulatory Agency authorizing device | Last Date for import |
|---|---|---|---|---|---|
| Positive Airway Pressure Device (Model CA720M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model CA720W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model BA725M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model BA725W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model ST730M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model ST730W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model AU730M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Positive Airway Pressure Device (Model AU730W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | 20464 | Guangdong Food and Drug |
2023-07-01 |
| Ultra Vent Ventilation Tube (Reg: 23-50900) | III | Invotec International Inc. | 283 | USFDA, EU-CE Mark | 2023-05-31 |
| T-Tube Ventilation Tube (Ref: 23-50600) | III | Invotec International Inc. | 283 | USFDA, EU-CE Mark | 2023-05-31 |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9524) | II | Pulmodyne, Inc. | 7119 | USFDA, EU-CE Mark | 2023-07-01 |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9525) | II | Pulmodyne, Inc. | 7119 | USFDA, EU-CE Mark | 2023-07-01 |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9526) | II | Pulmodyne, Inc. | 7119 | USFDA, EU-CE Mark | 2023-07-01 |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9527) | II | Pulmodyne, Inc. | 7119 | USFDA, EU-CE Mark | 2023-07-01 |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9602) | II | Pulmodyne, Inc. | 7119 | USFDA, EU-CE Mark | 2023-07-01 |
| 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) (REF: 11011P) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | MDEL 13800 | EU-CE Mark | 2023-07-31 |
| Spinal Needle (AN-S II) (REF: 31512P) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | MDEL 13800 | EU-CE Mark | 2023-07-31 |
| Epidural Anaesthesia Kit (AS-E) (REF: 40043B) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | MDEL 13796 | EU-CE Mark | 2023-07-31 |
| Spinal Needle (AN-S II) (REF: 31502P) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | MDEL 13800 | EU-CE Mark | 2023-07-31 |
| 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 |
2023-07-01 |
| Positive Airway Pressure Device (Model BA725) | II | Guangzhou Hypnus Healthcare Co., Ltd. | MDEL 20464 | Guangdong Food and Drug Administration People's Republic of China |
2023-07-01 |
| Positive Airway Pressure Device (Model ST730) | II | Guangzhou Hypnus Healthcare Co., Ltd. | MDEL 20464 | Guangdong Food and Drug Administration People's Republic of China |
2023-07-01 |
| 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 | 2023-06-30 |
| CPAP device (model: Vivo 1) | II | Breas Medical AB | MDEL 340 | European Commission, Sweden | 2023-07-01 |
| CPAP device (model: Vivo 2) | II | Breas Medical AB | MDEL 340 | European Commission, Sweden | 2023-07-01 |
| CPAP device (model: Vivo 3) | II | Breas Medical AB | MDEL 340 | European Commission, Sweden | 2023-07-01 |
| iBreeze CPAP System (model 20A) | II | Resvent Medical Technology Co., Ltd. | MDEL 19863 | U.S. Food and Drug Administration | 2023-07-01 |
| 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) (REF: 1201-18) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | MDEL 13800 | EU-CE Mark | 2023-07-31 |
| Anesthesia Kit (AS-E) (REF: 1201-20) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | MDEL 13800 | EU-CE Mark | 2023-07-31 |
| iBreeze CPAP System (Model 20A) | II | Resvent Medical Technology Co., Ltd. | MDEL 14912 | U.S. Food and Drug Administration | 2023-07-01 |
| Skin Stapler (Ref: LMPF-35W) | II | Changzhou Lookmed Medical Instruments | MDEL 13800 | USFDA, EU-CE Mark | 2023-06-30 |
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