TSXV:TTD - Post Discussion
Post by
GoodLuck14 on Apr 28, 2020 9:30am
Class 1 Devices.
Class I Devices
- Class I devices can be imported or manufactured without a device authorization if the manufacturer or importer holds a Medical Device Establishment Licence (MDEL). Consult the list of active MDELs to see whether a company is authorized to import or manufacture Class I medical devices.
- Certain Class I devices that may not fully meet regulatory requirements can be allowed into Canada under the authority of the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. This order was created due to the unprecedented demand and urgent need for access to medical devices during the COVID-19 pandemic. Consult the List of Medical Devices for Exceptional Importation and Sale for these devices.
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