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: 2025-02-20
Supersedes: 2025-02-18
Access archived versions of this list.
| Medical device name, identifier and class | Name of the manufacturer | Name of the importer and medical device establishment licence number | Country of authorization, name of foreign regulatory agency authorizing the device and authorization number (if applicable) | Date device added to this list | Date after which device may no longer be imported | Total number of units that may be imported |
|---|---|---|---|---|---|---|
| CuraSPON Size 100c (Ref: CS-650), Class IV | CuraMedical B.V. | Southmedic Inc., MDEL 420 | EU (UDI: B-08717903346501) |
2025-02-19 | 2025-03-31 | 360 |
| CuraSPON Tampon (Ref: CS-210), Class IV | CuraMedical B.V. | Southmedic Inc., MDEL 420 | EU (B-08717903342107) | 2025-02-12 | 2025-03-31 | 975 |
| Vacuum Assisted Venous Drainage Controller (VAVD), Class II | Boehringer Laboratories, LLC | Canadian Hospital Specialties Ltd., MDEL 72 | USFDA, Australia TGA, Japan MHLW |
2022-09-27 | 2023-09-30 | N/A |
| Ultra Vent Ventilation Tube (Ref: 23-50900), Class III | Invotec International Inc. | Dulong Medtech Inc., MDEL 283 | USFDA, EU-CE Mark | 2023-01-28 | 2023-12-30 | N/A |
| T-Tube Ventilation Tube (Ref: 23-50600), Class III | Invotec International Inc. | Dulong Medtech Inc., MDEL 283 | USFDA, EU-CE Mark | 2023-01-28 | 2023-12-30 | N/A |
| Superfine Microclip GEM (Identifier: GEM1521), Class III | Peters Surgical Vitalitec | Tsg Medical Inc., MDEL 6412 | EU-CE Mark, USFDA, Australia |
2023-09-14 | 2023-09-30 | 850 |
| Spinal Needle (AN-S II) (Ref: 31512P), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-01-30 | 2023-07-31 | N/A |
| Spinal Needle (AN-S II) (Ref: 31502P), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-01-30 | 2023-07-31 | N/A |
| Skin Stapler (Ref: LMPF-35W), Class II | Changzhou Lookmed Medical Instruments | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | USFDA, EU-CE Mark | 2022-12-06 | 2023-11-30 | N/A |
| Rocket® Copeland® Fetal Scalp Electrode (Ref: R57008-00-FM), Class II | Rocket Medical PLC | Advanced Surgi-Pharm/Batrik Medical Mfg./Imperial Surgical Ltd., MDEL 95 | Australia TGA, EU-CE Mark |
2023-03-07 | 2024-11-30 | 3,750 |
| Quadrox-i Neonatal Oxygenator (Ref: VKMO 11000), Class III | Maquet Cardiopulmonary GMBH | Getinge Canada Limited, MDEL 514 | USFDA | 2023-03-08 | 2023-12-31 | N/A |
| Positive Airway Pressure Device (Model #: ST730W), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: ST730M), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: ST730), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2023-07-01 | N/A |
| Positive Airway Pressure Device (Model #: CA720W), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: CA720M), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: CA720), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2023-07-01 | N/A |
| Positive Airway Pressure Device (Model #: BA725W), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: BA725M), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: BA725), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2023-07-01 | N/A |
| Positive Airway Pressure Device (Model #: AU730W), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Positive Airway Pressure Device (Model #: AU730M), Class II | Guangzhou Hypnus Healthcare Co., Ltd. | Tranq Medical And Technology Inc. Dba. Tmed, MDEL 20464 | National Medical Products Administration, P. R. China | 2023-02-14 | 2024-01-15 | N/A |
| Paragon Infant PP Oxygenator (Ref: XCMOP140PP), Class IV |
Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-02-16 | 2024-08-31 | 100 |
| Paragon Infant Integrated Oxygenator (Ref: XCMOPI140PP), Class IV |
Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-03-19 | 2024-05-26 | 200 |
| Paragon Adult Midi PP Oxygenator (Ref: XCMOP260PP), Class IV |
Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-02-16 | 2024-08-31 | 100 |
| Paragon Adult Midi Integrated Oxygenator (Ref: XCMOPI260PP), Class IV |
Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-03-19 | 2024-05-26 | 200 |
| Paragon Adult Maxi PP Oxygenator (Ref: XCMOP300PP), Class IV |
Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-02-16 | 2024-08-31 | 100 |
| Paragon Adult Maxi Integrated Oxygenator (Ref: XCMOPI300PP), Class IV |
Chalice Medical Limited | Ebbtides Medical Inc., MDEL 6025 | EU-CE Mark, UKCA | 2024-03-19 | 2024-05-26 | 200 |
| P-Eggy Chest Drain Valve (Model #: 10808), Class II | Redax S.p.A | Canadian Hospital Specialties Ltd. MDEL 72 | Ministry of Health, Italy | 2022-03-21 | 2023-06-30 | N/A |
| Microclip GEM (Identifier: GEM2431), Class III | Peters Surgical Vitalitec | Tsg Medical Inc., MDEL 6412 | EU-CE Mark, USFDA, Australia TGA |
2023-09-14 | 2023-09-30 | 850 |
| iBreeze CPAP System (Model #: 20A), Class II | Resvent Medical Technology Co., Ltd. | Snore Md Inc., MDEL 19863 | USFDA | 2022-03-28 | 2023-07-01 | N/A |
| iBreeze CPAP System (Model #: 20A), Class II | Resvent Medical Technology Co., Ltd. | Promedica Canada, MDEL 14912 | USFDA | 2022-08-18 | 2023-07-01 | N/A |
| Goldtrace spiral fetal electrode (Model #: CNS000004), Class II | Cetro Medical AB | Innovative Oncosolutions Inc., MDEL 6243 | Swedish Medical Products Agency | 2023-06-23 | 2024-05-06 | 10,000 |
| Goldtrace fetal spiral electrode (Model #: CNS000004), Class II | Cetro Medical AB | Advanced Surgi-Pharm Inc., MDEL 95 | Swedish Medical Products Agency | 2024-07-12 | 2024-11-11 | 3,000 |
| Fetal Blood Sampling Wand (Identifier: FBS-W), Class II | Bridge Master Medical | NRG Global MDEL 13800 | EU-CE Mark | 2023-12-20 | 2024-06-12 | 400 |
| Fetal Blood Sampling Kits (Identifiers: R57028-00-SW, R57026-00-SW, R57024-00-SW), Class II |
Rocket Medical PLC | Advanced Surgi-Pharm Inc., MDEL: 95 | Australia TGA | 2024-02-08 | 2024-12-31 | 2300 |
| Fetal Blood Sampling Kit (Identifier: FBS-AC), Class II | Bridge Master Medical | NRG Global MDEL 13800 | Australia TGA | 2023-12-20 | 2024-06-12 | 400 |
| Epidural Needle (AN-E) (Ref: 11011P), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2023-01-30 | 2023-07-31 | N/A |
| Epidural Anaesthesia Kit (AS-E) (Ref: 40043B), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 2001 Investments Ltd., MDEL 13796 | EU-CE Mark | 2022-08-30 | 2023-07-31 | N/A |
| EndoTube tracheal tube uncuffed with Murphy Eye, (Identifiers: 411030, 411035, 411040, 411045, 411050, 411055, 411060), Class II |
Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2023-12-28 | 2024-08-31 | 200 |
| EndoTube tracheal tube pre-formed oral, uncuffed, Murphy Eye, (Identifiers: 431030, 431035, 431040, 431045, 431050, 431055, 431060), Class II |
Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2023-12-28 | 2024-08-31 | 200 |
| EndoTube tracheal tube pre-formed oral, cuffed, Murphy Eye, (Identifiers: 420035, 420040, 420045, 420050, 420055, 420060, 420065, 420070, 420075, 420080), Class II |
Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2023-12-28 | 2024-08-31 | 200 |
| EndoTube tracheal tube pre-formed nasal, uncuffed, Murphy Eye, (Identifiers: 451030, 451035, 451040, 451045, 451050, 451055, 451060), Class II |
Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2023-12-28 | 2024-08-31 | 200 |
| EndoTube tracheal tube pre-formed nasal, cuffed, Murphy Eye, (Identifiers: 440035, 440040, 440045, 440050, 440055, 440060, 440065, 440070), Class II |
Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2023-12-28 | 2024-08-31 | 200 |
| EndoTube tracheal tube HV/LP cuff with Murphy Eye, (Identifiers: 401030, 401035, 401040, 401045, 401050, 401055, 401060, 401065, 401070, 401075, 401080, 401085), Class II |
Merlyn Associates, Inc. DBA Merlyn Medical | Mss Ltd., MDEL 2442 | USFDA | 2023-12-28 | 2024-08-31 | 200 |
| Electronically Illuminated Amnioscope (Identifier: ELA-01), Class II | Bridge Master Medical | NRG Global MDEL 13800 | EU-CE Mark | 2023-12-20 | 2024-06-12 | 400 |
| Disposable Spinal Anaesthesia Kit (AS-S), (Ref: RSK 021), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | National Medical Products Administration, P. R. China | 2023-03-24 | 2023-07-31 | N/A |
| Disposable Skin Stapler (Ref : SKINPRO35W), Class II | Fesocon Medical Ltd | Pronorth Medical Co., MDEL 6151 | USFDA | 2023-03-28 | 2023-11-30 | N/A |
| Dentech Thoracic Chest Drainage System (Variant model #: 10112), Class II | Redax S.p.A | Canadian Hospital Specialties Ltd., MDEL 72 | Ministry of Health, Italy | 2021-12-23 | 2022-12-21 | N/A |
| Dentech Thoracic Chest Drainage System (Dune model #: 10113), Class II | Redax S.p.A | Canadian Hospital Specialties Ltd., MDEL 72 | Ministry of Health, Italy | 2021-12-23 | 2022-12-21 | N/A |
| CPAP device (Model #: Vivo 3), Class II | Breas Medical AB | Mcarthur Medical Sales, Inc., MDEL 340 | Swedish Medical Products Agency | 2022-04-26 | 2023-07-01 | N/A |
| CPAP device (Model #: Vivo 2), Class II | Breas Medical AB | Mcarthur Medical Sales, Inc., MDEL 340 | Swedish Medical Products Agency | 2022-04-26 | 2023-07-01 | N/A |
| CPAP device (Model #: Vivo 1), Class II | Breas Medical AB | Mcarthur Medical Sales, Inc., MDEL 340 | Swedish Medical Products Agency | 2022-04-26 | 2023-07-01 | N/A |
| Anesthesia Kit (AS-E) (Ref: 1201-20), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2022-08-12 | 2023-07-31 | N/A |
| Anesthesia Kit (AS-E) (Ref: 1201-18), Class II | Zhejiang Runqiang Medical Instruments Co., Ltd. | 9215 5498 Qc Inc Dba Nrg Global Sourcing, MDEL 13800 | EU-CE Mark | 2022-08-12 | 2023-07-31 | N/A |
| CuraSPON Size 100 (Ref: CS-610), Class IV | CuraMedical B.V. | Southmedic Inc., MDEL 420 | EU (B-08717903346105) | 2024-12-06 | 2025-03-31 | 41,610 |
| CuraSPON Size 12-7 (Ref: CS-060), Class IV | CuraMedical B.V. | Southmedic Inc., MDEL 420 | EU (B-08717903340608) | 2024-12-06 | 2025-03-31 | 80,000 |
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