As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of medical devices for use in relation to COVID-19. Interm Order No. 2 will continue to issue expedited authorizations for the sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.
The Interim Order provides an expedited authorization pathway for:
- new COVID-19 medical devices that are not yet licensed in Canada,
- COVID-19 related uses for existing devices licensed under the Medical Devices Regulations or Interim Order No. 2 and
- COVID-19 medical devices that leverage an authorization of a device from a trusted foreign regulatory authority, whereby the Minister would maintain the ability to request additional information on a case-by-case basis.
Interim Order No. 2 introduces new requirements for importers and distributors of COVID-19 medical devices to hold an MDEL, and for manufacturers to comply with bilingual labelling requirements. Both of these changes align with requirements in the Medical Devices Regulations.
Authorization for importation or sale by the manufacturer
Interim Order No. 2 provides COVID-19 medical device manufacturers an exemption from certain requirements of the Medical Devices Regulations, provided they have received an authorization for the importation or sale of their device(s) from Health Canada.
A manufacturer may submit an application for authorization under Interim Order No. 2. If an authorization is granted, the manufacturer may import or sell the COVID-19 medical device for which they hold an IO authorization in Canada. The manufacturer’s information and device information on the device label can then be cross-referenced against the IO authorization during importation and distribution, which is required to accompany the product during import.
Fees related to the submission of an application for a COVID-19 medical device authorization
Health Canada will waive all application fees for COVID-19 medical device authorizations subject to Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
Quality Management System requirements related to the submission of an application for a COVID-19 medical device
Health Canada does not require manufacturers to provide a Medical Device Single Audit Program (MDSAP) certificate with their application for a COVID-19 medical device subject to Interim Order No. 2. Manufacturers will be required to share information to demonstrate that their products are of consistent quality and effectiveness. This can be demonstrated by either providing a copy of the manufacturer’s Quality Management System certificate to ISO 13485:2016, or by submitting evidence of Good Manufacturing Practices and its proper implementation.
Documentation required for importation
Under Interim Order No. 2, each shipment of a COVID-19 medical device that is imported into Canada must be accompanied by a copy of the Interim Order authorization. This document will be issued to the applicant upon authorization and will facilitate transport of the COVID-19 medical device(s) across the border, as it will be used as a signal that the device has been authorized under the Interim Order. Importers should rely on this mechanism to demonstrate to Health Canada that a shipment containing COVID-19 medical devices should be allowed access into Canada. References to Interim Order No. 1 on the authorizations can be read to be references to Interim Order No. 2.
Interim Order No. 2 requires that the holder of the COVID-19 medical device authorization for the importation or sale of the device report to Health Canada to comply with incident reporting requirements.
Importers and distributors also must comply with mandatory reporting as outlined in the Medical Devices Regulations. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.
Requirement for importers and distributors to hold a Medical Device Establishment Licence (MDEL)
Under Interim Order No. 1, importers and distributors were not required to hold an active Medical Device Establishment Licence (MDEL) to import or distribute COVID-19 medical devices authorized under the IO. To enable risk-based regulatory oversight on the medical device supply chain and facilitate complete and rapid recalls of problematic devices when necessary, Health Canada has added this requirement to Interim Order No. 2.
Requirement to hold an MDEL
Interim Order No. 2 requires importers and distributors of COVID-19 medical devices to hold an MDEL and comply with certain requirements set out in the Medical Devices Regulations.
COVID-19 medical device importers and distributors:
- have six months from the date that Interim Order No. 2 takes effect to obtain an MDEL and comply with relevant parts of the Medical Devices Regulations as defined in section 2(2)(a) of the Order (by September 1, 2021)
- must submit applications for an MDEL within sufficient time to accommodate the service standard of 120 calendar days
- are required to pay application fees, as well as annual fees, for as long as they hold an MDEL
MDEL holders are subject to other regulatory requirements, including record-keeping, reporting and inspections. Health Canada inspectors verify that the MDEL holder has the ability to conduct rapid, effective recalls of problematic devices when necessary.
Consult the existing Guidance Document for Mandatory Problem Reporting for Medical Devices for information on how to comply with those sections. Importers and distributors should also note that new regulations on mandatory reporting under the Medical Devices Regulations will come into effect on June 23, 2021, at which point importers will be expected to comply with the new regulations.
Importers and distributors of any medical devices (including COVID-19 medical devices) who are required to hold an MDEL, must pay the associated MDEL fee, and comply with requirements set out in the Medical Devices Regulations.
For more information pertaining to MDEL fees, please review the Fees for the Review of Medical Device Establishment Licence Applications at the official website of Health Canada.
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