March 26, 2020 – On March 18, 2020, the Minister of Health approved an Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19. The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19. Interim Orders can remain in effect for 14 days and can be extended for up to one year by the Governor in Council, after which they may be renewed if required.
To facilitate earlier access to a vaccine, or therapeutic product for COVID-19, the Health Canada will expedite the review of any COVID-19 related health product submissions and applications. Doing this will ensure timely access to novel therapies without compromising the safety, efficacy and quality of products.
With this Interim Order, Health Canada could also look to approvals granted by foreign regulatory authorities (government agency or other entity) in deciding whether to approve an application for the importation or sale of COVID-19-related medical devices. Existing devices, where the approved, intended use was not originally COVID-19-related, could also be expanded under this Interim Order.
An Interim Order is one of the fastest mechanisms available to the Government of Canada to help make health products available to address larger scale public health emergencies. This Interim Order provides the Minister with the flexibility to consider the urgent circumstances relating to the need for the medical device, authorizations granted by foreign regulatory authorities, or possible new uses for medical devices that are approved in Canada.
As with all drugs and medical devices, Health Canada will assess and monitor the safety and effectiveness of the devices accessed under this Interim Order once they are on the market, and will take immediate action to protect the health and safety of Canadians if necessary.
A COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Each shipment of a COVID-19 medical device under the interim order that is imported into Canada must be accompanied by a copy of the authorization for importation.
The list of medical devices for expanded use in relation to the COVID-19 pandemic will be published on the Government of Canada website.
Review the Interim Order issued by the Minster of Health which contains information, conditions to be met and specific details on importing and the sale of medical devices for use in COVID-19.
Health Canada will expedite the review of any COVID-19 related health product submissions and applications. Doing this will ensure timely access to novel therapies without compromising the safety, efficacy and quality of products.
Sponsors wishing to file a submission or application should contact the appropriate review bureau.
Review Bureau Contact Information:
Biologic and Radiopharmaceutical Drugs Directorate
Office of Regulatory Affairs
Tel: 613-957-1722
Fax: 613-946-9520
E-mail: hc.brdd.ora.sc@canada.ca
Therapeutic Products Directorate:
Bureau of Gastroenterology, Infection and Viral Diseases
Telephone: 613-941-2566
Fax: 613-941-1183
E-mail: hc.bgivd.enquiries.sc@canada.ca
Submission Management Division, Office of Clinical Trials
Fax: 613-946-7996
E-mail: hc.oct_bec_enquiries.sc@canada.ca
Special Access Program- drugs
Telephone: 613-941-2108
Fax: 613-941-3194
E-mail: hc.sapd-pasm.sc@canada.ca
Natural and Non-prescription Health Products Directorate (NNHPD)
Regulatory Project Management Unit, servicing Non-prescription Drug Evaluation Division
Fax: 613-946-9614
Telephone: 613-946-9315
Telephone: 613-957-6801 for the Regulatory Project Management Unit
Email: hc.nnhpd-dpsnso.sc@canada.ca
Medical Device Directorate:
Bureau of Device Licensing Services
Email: hc.devicelicensing-homologationinstruments.sc@canada.ca.
Investigational Testing
Telephone: 613-941-4308
E-mail: hc.it-ee.sc@canada.ca
Special Access Program – Medical Devices
Tel: 613-946-8711
Fax: 613-957-1596
E-mail: hc.sap.devices.mdb.sc@canada.ca