Importation and sale of medical devices for COVID-19 guidance document: Provide a notification of importation
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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.
When notifying Health Canada, an establishment must provide the following information (see subsection 21(2) of the IO):
- importer's name and contact information
- contact name, company name, company identification number (if known) and contact information (telephone, fax, email and address)
- device identifier information
- name of the device and of any component, part or accessory of the device, including the model name (if applicable)
- identifier of the device and any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family, including (if applicable or available):
- name as per the product label
- licensing information, such as the medical device licence (MDL) or medical device establishment licence (MDEL) number
- identifiers such as the bar code, catalogue, model or part number
- manufacturer information
- contact name, company name, company identification number and contact information (telephone, fax, email and address)
- this information should be consistent with the information on the manufacturer of the device as it appears on the device label
- manufacturing site information, if it differs from that of the manufacturer
- company name and company identification number (if known)
- address of manufacturing site
- purpose, intended use, performance specifications
- detailed description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented
- performance specifications of the device if those specifications are necessary for proper use
- if applicable, the applicant is to provide a description of how the device may not comply with the regulatory requirements under normal circumstances (for example, non-bilingual labelling, expired product, different intended use)
- intended port of entry into Canada
- name of the airport, land crossing or sea port
- estimated arrival date
- estimated day, month and year of the arrival of the device shipment
- customs identification number
- number of units
- total number of individual device units to be imported
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:
- all the information submitted in support of the notification is accurate and complete
- the applicant has demonstrated it has procedures in place for distribution records, handling complaints, mandatory problem reporting and recalls
- labels for all devices listed on the notification are attached
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:
- submit labelling in both English and French immediately before or as part of the notification
- make bilingual labelling available for the purchaser
Email the completed notification form to Health Canada: email@example.com.
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