Importation and sale of medical devices for COVID-19 guidance document: Provide a notification of importation

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Notification

Once a device is placed on the list, establishments must notify Health Canada at least 5 calendar days before the day on which the device is imported. This notification is required for each shipment.

Failure to notify Health Canada within this timeframe may lead to compliance and enforcement actions.

To notify Health Canada, an establishment must complete and submit the following form:

Along with the notification, the establishment must submit the information requested to comply with the condition(s) for the designated device, if applicable.

Before sending the form to Health Canada, make sure the information is accurate, complete and meets the requirements of the interim order (IO). Submission of complete forms within the timeframe will help prevent processing delays.

Required information

When notifying Health Canada, an establishment must provide the following information (see subsection 21(2) of the IO): 

Signature and attestation

While not specifically required by the IO, applicants are encouraged to date and sign the notification form.

Health Canada also recommends that applicants include an attestation that:

To expedite access to COVID-19 medical devices to the Canadian market, Health Canada will accept labelling in either English or French at the time of application. However, establishments are required to:

Email the completed notification form to Health Canada:  hc.medicaldevices.covid19.instrumentsmedicaux.sc@canada.ca.

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