Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) if there is no longer an urgent public health need (UPHN) for those devices. The notice states that there is no longer an UPHN for thermometers and ventilators.
The Minister of Health originally issued IO No. 1 to facilitate expedited evaluations by Health Canada of abbreviated applications for the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19. IO No. 2 extends the flexibilities of IO No. 1 so that COVID-19 devices authorized under IO No. 1 can continue to be imported and sold in Canada without any further actions taken by the manufacturer. IO No. 2, along with all authorizations granted or extended under it, will expire on March 1, 2022, unless it is repealed or superseded by regulations sooner.
Urgent Public Health Need
For a COVID-19 medical device to be authorized under IO No. 2, the Minister must find that there is an UPHN for that device, meaning the device is immediately required to protect or improve the health of individuals or communities in Canada.
In making an UPHN determination for a medical device, Health Canada considers a number of factors, including:
- the device’s supply and demand;
- how long the device lasts;
- the device’s clinical need; and
- the status of the COVID-19 pandemic in Canada.
Health Canada will reject IO No. 2 applications which lack enough evidence of a UPHN.
Medical Devices Losing UPHN Status
Based on the current COVID-19 pandemic conditions in Canada, Health Canada has determined that thermometers and ventilators no longer hold UPHN status as of July 16, 2021. IO No. 2 applications submitted, or authorizations secured, before July 16, 2021 for thermometers or ventilators are unaffected by this update.
Health Canada will reassess the status of these devices should their supply and demand change. Further, an authorization may still be possible for thermometers or ventilators if an applicant is able to provide enough UPHN evidence for their device. An attestation from a Canadian health authority stating that a UPHN exists for that medical device is an example of such evidence.
Applicants can still pursue medical device establishment licences (Class I) and medical device licences (Classes II to IV) for all types of medical devices under the Medical Devices Regulations pathway. Digital thermometers are typically classified as Class II devices, while ventilators are typically classified as Class III devices. Further information on obtaining such licences can be found in Health Canada’s guidance documents for medical device establishment licenses and medical device licences, respectively.
- Medical devices no longer considered to have urgent public health need status: Notice to industry
- Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 18, 2020; repealed and replaced by IO #2) (IO No. 1)
- Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 1, 2021) (IO No. 2)
- Medical Device Regulations, SOR/98-282
- Guidance Document – How to Complete the Application for a New Medical Device Licence
- Guidance on Medical Device Establishment Licensing (GUI-0016) – Summary