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 "Date after which the device may no longer be imported" 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 "Date after which the device may no longer be imported" column.
Date issued: 2024-07-12
Supersedes: 2024-06-18
Access archived versions of this list.
| Medical device name and identifier | Medical device class | Name of the manufacturer | Name of the importer and MDEL number | Name of the foreign regulatory agency authorizing the device | Date after which the device may no longer be imported | Total number of units that may be imported |
|---|---|---|---|---|---|---|
| Goldtrace fetal spiral electrode (Model: CNS000004) | II | Cetro Medical AB | Advanced Surgi-Pharm Inc., MDEL 95 | Swedish Medical Products Agency | 2024-11-11 | 3,000 |
| Paragon Adult Maxi Integrated Oxygenator (XCMOPI300PP) |
IV | Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-05-26 | 200 |
| Paragon Adult Midi Integrated Oxygenator (XCMOPI260PP) |
IV | Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-05-26 | 200 |
| Paragon Infant Integrated Oxygenator (XCMOPI140PP) |
IV | Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-05-26 | 200 |
| Paragon Adult Maxi PP Oxygenator (XCMOP300PP) |
IV | Chalice Medical Limited | Ebbtides Medical Inc. | EU | 2024/08/31 | 100 |
| Paragon Adult Midi PP Oxygenator (XCMOP260PP) |
IV | Chalice Medical Limited | Ebbtides Medical Inc. | EU | 2024/08/31 | 100 |
| Paragon Infant PP Oxygenator (XCMOP140PP) |
IV | Chalice Medical Limited | Ebbtides Medical Inc. | EU | 2024/08/31 | 100 |
EndoTube tracheal tube HV/LP cuff with Murphy Eye, |
II | Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2024-08-31 | 200 |
EndoTube tracheal tube uncuffed with Murphy Eye, |
II | Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2024-08-31 | 200 |
EndoTube tracheal tube pre-formed oral, cuffed, Murphy Eye, |
II | Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2024-08-31 | 200 |
EndoTube tracheal tube pre-formed oral, uncuffed, Murphy Eye, |
II | Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2024-08-31 | 200 |
EndoTube tracheal tube pre-formed nasal, cuffed, Murphy Eye, |
II | Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2024-08-31 | 200 |
EndoTube tracheal tube pre-formed nasal, uncuffed, Murphy Eye, |
II | Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2024-08-31 | 200 |
| Electronically Illuminated Amnioscope (identifier: ELA-01) | II | Bridge Master Medical | NRG Global MDEL 13800 | EU | 2024-06-12 | 400 |
| Fetal Blood Sampling Kit (identifier: FBS-AC) | II | Bridge Master Medical | NRG Global MDEL 13800 | Australia TGA | 2024-06-12 | 400 |
| Fetal Blood Sampling Wand (identifier: FBS-W) | II | Bridge Master Medical | NRG Global MDEL 13800 | EU | 2024-06-12 | 400 |
| Anesthesia Kit (AS-E) (REF: 1201-18) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-07-31 | N/A |
| Anesthesia Kit (AS-E) (REF: 1201-20) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-07-31 | N/A |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9524) | II | Pulmodyne, Inc. | Intersurgical Ltd., MDEL 7119 | USFDA, EU-CE Mark | 2023-07-01 | N/A |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9525) | II | Pulmodyne, Inc. | Intersurgical Ltd., MDEL 7119 | USFDA, EU-CE Mark | 2023-07-01 | N/A |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9526) | II | Pulmodyne, Inc. | Intersurgical Ltd., MDEL 7119 | USFDA, EU-CE Mark | 2023-07-01 | N/A |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9527) | II | Pulmodyne, Inc. | Intersurgical Ltd., MDEL 7119 | USFDA, EU-CE Mark | 2023-07-01 | N/A |
| BiTrac MaxShield Select™ Pediatric Mask (Ref: 313-9602) | II | Pulmodyne, Inc. | Intersurgical Ltd., MDEL 7119 | USFDA, EU-CE Mark | 2023-07-01 | N/A |
| Champak N95 Respirator F550 | I | Champak Enterprise Co., Ltd. | Acroyal Epi Inc., MDEL 13227 | USFDA | 2023-01-01 | N/A |
| Champak N95 Respirator F550 | I | Champak Enterprise Co., Ltd. | Acroyal Epi Inc., MDEL 13227 | N/A | 2022-03-02 | N/A |
| CPAP device (model: Vivo 1) | II | Breas Medical AB | Mcarthur Medical Sales, Inc., MDEL 340 | European Commission, Sweden | 2023-07-01 | N/A |
| CPAP device (model: Vivo 2) | II | Breas Medical AB | Mcarthur Medical Sales, Inc., MDEL 340 | European Commission, Sweden | 2023-07-01 | N/A |
| CPAP device (model: Vivo 3) | II | Breas Medical AB | Mcarthur Medical Sales, Inc., MDEL 340 | European Commission, Sweden | 2023-07-01 | N/A |
| Dentech Thoracic Chest Drainage System (Dune model #10113) | II | Redax S.p.A | Canadian Hospital Specialties Ltd., MDEL 72 | Ministry of Health, Italy | 2022-12-21 | N/A |
| Dentech Thoracic Chest Drainage System (Variant model #10112) | II | Redax S.p.A | Canadian Hospital Specialties Ltd., MDEL 72 | Ministry of Health, Italy | 2022-12-21 | N/A |
| Disposable 3-ply non-woven medical face mask with ear loops | I | Hubei Qianjiang Kingphar Medical Material Co. Ltd. | Origin Protective Dba Origin Fr Inc., MDEL 12291 | N/A | 2022-03-02 | N/A |
| Disposable CPE isolation gown | I | Shandong Housewares Manufacturing Co., Ltd. | 1520198 Ontario Inc Dba Dk International Group, MDEL 12586 | N/A | 2022-03-02 | N/A |
| Disposable Medical Face Mask | I | Sunsmed Protective Products Ltd. | Bunzl Canada Inc., MDEL 726 | N/A | 2022-03-02 | N/A |
| Disposable Nitrile Examination gloves (Blue; Size XXL) | II | Blue Sail Medical Co. Ltd. | 7132221 Canada Inc Operating As Hawktree Solutions, MDEL 4507 | Health Canada | 2022-10-31 | N/A |
| Disposable Skin Stapler (Ref : SKINPRO35W) | II | Fesocon Medical Ltd | Pronorth Medical Co., MDEL 6151 | USFDA | 2023-11-30 | N/A |
| Disposable Spinal Anaesthesia Kit (AS-S), (Ref: RSK 021) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | National Medical Products Administration, P. R. China | 2023-07-31 | N/A |
| Epidural Anaesthesia Kit (AS-E) (REF: 40043B) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 2001 Investments Ltd., MDEL 13796 | EU-CE Mark | 2023-07-31 | N/A |
| Epidural Needle (AN-E) (REF: 11011P) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-07-31 | N/A |
| Fluid Resistant 4-ply Procedure Mask | I | Lam Khang General Joint Stock Company | Minerva Pharmaceuticals Ltd. Dba Minerva Medical, MDEL 6279 | N/A | 2022-03-02 | N/A |
| Goldtrace spiral fetal electrode (Model: CNS000004) | II | Cetro Medical AB | Innovative Oncosolutions Inc., MDEL 6243 | Swedish Medical Products Agency | 2024-05-06 | 10,000 |
| iBreeze CPAP System (model 20A) | II | Resvent Medical Technology Co., Ltd. | Snore Md Inc., MDEL 19863 | U.S. Food and Drug Administration | 2023-07-01 | N/A |
| iBreeze CPAP System (Model 20A) | II | Resvent Medical Technology Co., Ltd. | Promedica Canada, MDEL 14912 | U.S. Food and Drug Administration | 2023-07-01 | N/A |
| Isolation Gown | I | Showing Polymer Limited | Top Dog Manufacturing, MDEL 11721 | N/A | 2022-03-02 | N/A |
| Microclip GEM (Identifier: GEM2431) | III | Peters Surgical Vitalitec | Tsg Medical Inc., MDEL 6412 | EU-CE Mark, |
2023-09-30 | 850 |
| McKesson Powder-Free Nitrile Exam Gloves, Confiderm 3.5C | II | Hartalega NGC Sdn Bhd | Mckesson Specialized Distribution Inc., MDEL 4063 | Health Canada | 2022-03-02 | N/A |
| Medical Grade Face Masks | I | V&Q Manufacturing Corporation | Rxbio Corp., MDEL 9174 | N/A | 2022-03-02 | N/A |
| N95 Respirators | I | Makrite Industries Inc. | Chine Vision Inc. Dba Distribution Ad Valorem, MDEL 11593 | N/A | 2022-03-02 | N/A |
| Non-Woven Face Masks | I | Shenzhen Delong Huale Electronic Co. Ltd | Atlas Medic Inc., MDEL 2332 | N/A | 2022-03-02 | N/A |
| Non-Woven Face Masks | I | Xiantao Xingrong Protective Products Co., Ltd. | Atlas Medic Inc., MDEL 2332 | N/A | 2022-03-02 | N/A |
| Non-Woven Isolation Gown | I | Zibo Minghui Logo Clothing Co., Ltd. | Origin Protective Dba Origin Fr Inc., MDEL 12291 | N/A | 2022-03-02 | N/A |
| P-Eggy Chest Drain Valve (Model #10808) | II | Redax S.p.A | Canadian Hospital Specialties Ltd. MDEL 72 | Ministry of Health, Italy | 2023-06-30 | N/A |
| Positive Airway Pressure Device (Model AU730M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China |
2024-01-15 | N/A |
| Positive Airway Pressure Device (Model AU730W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China |
2024-01-15 | N/A |
| Positive Airway Pressure Device (Model BA725) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-07-01 | N/A |
| Positive Airway Pressure Device (Model BA725M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model BA725W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model CA720) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-07-01 | N/A |
| Positive Airway Pressure Device (Model CA720M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model CA720W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model ST730) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-07-01 | N/A |
| Positive Airway Pressure Device (Model ST730M) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model ST730W) | II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2024-01-15 | N/A |
| Powder Free Nitrile Examination Gloves (Blue Color) | II | Shijiazhuang Hongray Group Co. Ltd. | Ekomed Global Inc., MDEL 11585 | Health Canada | 2022-03-02 | N/A |
| Quadrox-i Neonatal Oxygenator (Ref: VKMO 11000) | III | Maquet Cardiopulmonary GMBH | Getinge Canada Limited, MDEL 514 | USFDA | 2023-12-31 | N/A |
| Rocket® Copeland® Fetal Scalp Electrode (REF: R57008-00-FM) | II | Rocket Medical PLC | Advanced Surgi-Pharm/Batrik Medical Mfg./Imperial Surgical Ltd., MDEL 95 | Australia TGA, EU-CE Mark |
2024-11-30 | 3,750 |
| Skin Stapler (Ref: LMPF-35W) | II | Changzhou Lookmed Medical Instruments | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | USFDA, EU-CE Mark | 2023-11-30 | N/A |
| Spinal Needle (AN-S II) (REF: 31502P) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-07-31 | N/A |
| Spinal Needle (AN-S II) (REF: 31512P) | II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-07-31 | N/A |
| Superfine Microclip GEM (Identifier: GEM1521) | III | Peters Surgical Vitalitec | Tsg Medical Inc., MDEL 6412 | EU-CE Mark, |
2023-09-30 | 850 |
| T-Tube Ventilation Tube (Ref: 23-50600) | III | Invotec International Inc. | Dulong Medtech Inc., MDEL 283 | USFDA, EU-CE Mark | 2023-12-30 | N/A |
| Ultra Vent Ventilation Tube (Reg: 23-50900) | III | Invotec International Inc. | Dulong Medtech Inc., MDEL 283 | USFDA, EU-CE Mark | 2023-12-30 | N/A |
| Vacuum Assisted Venous Drainage Controller (VAVD) | II | Boehringer Laboratories, LLC | Canadian Hospital Specialties Ltd., MDEL 72 | USFDA, Australia TGA, Japan MHLW |
2023-09-30 | N/A |
Fetal Blood Sampling Kits
|
II | Rocket Medical PLC | Advanced Surgi-Pharm Inc., MDEL: 95 | Australia TGA | 2024-12-31 | 2300 |
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