Medical devices for use in relation to COVID-19: Additional requirements for non-UPHN medical devices
On this page
- Removal from the UPHN list
- Requirements for Class I device manufacturers
- Requirements for Class II to IV device manufacturers
Removal from the UPHN list
Considerations when removing a device from the UPHN list
The UPHN list is an ambulatory list incorporated by reference and may be amended from time to time.
As such, Health Canada will continue to assess the urgent public health need (UPHN) of COVID-19 medical devices, taking into account the state of the pandemic. This approach allows us to:
- focus resources on reviewing COVID-19 devices that people in Canada still urgently require
- communicate to industry any gaps that exist in categories of authorized devices
An amendment to the UPHN list may result in a device from Part 1 of the list or a category of devices from Part 2 of the list being removed. The Minister must have reasonable grounds to believe that there is no longer a UPHN related to COVID-19 for the device or devices in that category.
Removal of a listing from the UPHN list
Notices to inform the public and stakeholders of changes to the UPHN list are published on the UPHN list page.
Once a device or category of devices is removed from the UPHN list, the manufacturer must comply with additional requirements for the class of medical device to continue to import or sell the medical device.
We will contact manufacturers with authorizations under Part 1.1 of the MDR who are affected by the removal of the listing from the UPHN list.
Requirements for Class I device manufacturers
Manufacturers of Class I COVID-19 medical devices that hold an authorization under Part 1.1 are not required to hold an MDEL. However, this exemption only applies as long as the medical device is included on the UPHN list.
At that point, if the authorization holder wishes to continue selling or importing their Class I COVID-19 medical device in Canada, they will need to comply with Part 1 of the MDR.
Requirement to apply for a medical device establishment licence
A Class I COVID-19 medical device authorization holder will have 120 days after the day on which the COVID-19 medical device is removed from the UPHN list to apply for an MDEL. Or, they can choose to import or distribute solely through an existing MDEL holder.
A Class I COVID-19 medical device authorization holder whose medical device is not included on the UPHN list when the Regulations come into force will have 120 days after the day on which the Regulations come into force to apply for an MDEL. Or, they can choose to import or distribute solely through an existing MDEL holder.
During the application period and throughout the process of obtaining an MDEL, the authorization under Part 1.1 of the MDR will remain active. As per subsection 68.22(a) of the MDR, once the manufacturer is issued an MDEL, the authorization is cancelled.
For more information on how to submit an MDEL application, please consult:
For questions about the MDEL process, email:
mdel.questions.leim@hc-sc.gc.ca
Payment of fees
Once a Class I medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available, to continue to import or sell the medical device, the authorization holder must:
- apply for an MDEL and
- pay all associated MDEL application fees
Existing establishment licensing fees will be applied.
- Some establishments may be eligible for small business fee mitigation, where the full fee is reduced by 25%.
- Existing penalties and accountability standards for Class I MDEL applications will apply, as per the performance standards for the Fees Order.
If a Class I medical device or category of medical devices is re-added to the UPHN list after the manufacturer started paying fees, fees will be waived from that time until the device is removed from the UPHN list. Health Canada will not reimburse paid fees or charge fees retroactively.
Considerations:
- If a Class I medical device or category of medical devices is added or re-added to the UPHN list within the 120-day deadline to apply for an MDEL and the holder has not received their MDEL yet, fees would be waived. The holder would need to ask Health Canada to stop processing their request for an MDEL.
- If a holder received their MDEL and had transferred to Part 1 of the MDR, fees would continue to apply even though their device is back on the UPHN list, as they are no longer regulated under Part 1.1. Unless the holder cancels their MDEL under Part 1 and applies for an authorization for a UPHN medical device under Part 1.1, they cannot hold both an MDEL and an authorization.
For more information, please consult the following guidance document:
Requirements for Class II to IV device manufacturers
Manufacturers of Class II to IV COVID-19 medical devices can maintain their COVID-19 authorization under Part 1.1 of the MDR after their device is removed from the UPHN list. To do so, they must comply with the following additional requirements.
Authorization holders whose medical devices are not on the UPHN list when the list first becomes available must comply as soon as the Regulations come into force.
Quality management system (QMS) certificate requirements
To remain authorized under Part 1.1 of the MDR after a Class II to IV COVID-19 medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available, the authorization holder will need to:
- submit a signed certification contract to the Minister within 120 days after the day on which their medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available, to indicate that the certification process under Medical Device Single Audit Program (MDSAP) has been initiated
- submit a copy of the MDSAP-compliant QMS certificate issued by the registrar that is recognized by the Minister within 2 years after the day on which the COVID-19 medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available
Authorization holders of Class II COVID-19 medical devices must submit a copy of the QMS certificate. This certificate certifies that the quality management system under which the device is manufactured meets the requirements of the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time (paragraph 32(2)(f) of the MDR).
Authorization holders of Class III and IV COVID-19 medical devices must submit a copy of the QMS certificate. This certificate certifies that the quality management system under which the device is designed and manufactured meets the requirements of the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time (paragraphs 32(3)(j) and 32(4)(p) of the MDR).
These authorization holders must also provide the Minister a copy of any updated certificates (such as a new or modified QMS certificate) within 30 days after the new certificate is issued. This requirement aligns with those imposed on holders of licensed medical devices under Part 1 of the MDR.
During the certification process, the authorization under Part 1.1 of the MDR will remain active.
If a medical device or category of device is added or re-added to the UPHN list while the certification process has been initiated by an authorization holder of the device in question, the holder may decide to stop or continue the certification process. However, Health Canada will not reimburse any paid fees.
Payment of fees
If a Class II to IV medical device or category of medical device is not on the UPHN list or is subsequently removed from the UPHN list, the manufacturer must pay certain fees to maintain their authorization.
- Once a device is not on the UPHN list, any amendments to the device authorization would require the existing applicable amendment examination fees to be paid.
- Once a device is not on the UPHN list, it will be charged the existing medical device right-to-sell fee initiated by the annual renewal requirements due on November 1.
- Payment of the right-to-sell fee is due every year on December 20.
- Some companies may be eligible for existing small business fee mitigation:
- a 50% reduction in all examination fees for amendments
- a 25% reduction for all right-to-sell fees
- Existing penalties and accountability standards for medical device applications will apply as per the performance standards for the Fees Order.
If a medical device or category of medical device is added or re-added to the UPHN list after the manufacturer started paying fees, the manufacturer will not have to pay fees from that point on until the device is removed from the UPHN list. Health Canada will not reimburse paid fees, nor will we charge fees retroactively.
For more information, please consult the following guidance document:
Annual review
Authorization holders of Class II to IV COVID-19 medical devices will also be subject to annual review requirements under section 68.24 of the MDR if they wish to continue importing and selling their medical device once the device is not on the UPHN list. The annual review requirements mirror the licence renewal process requirements in Part 1 of the MDR.
Every year before November 1, authorization holders of Class II to IV COVID-19 medical devices that are not on the UPHN list who wish to maintain their authorization must inform the Minister they intend to continue selling their device. They must:
- confirm that all the information and documents they submitted concerning their device are still correct or
- describe any change to the information and documents they submitted, other than:
- those to be submitted in a subsequent amendment under section 68.14 of the MDR or
- a new or modified QMS certificate required as per section 68.34 of the MDR
Foreign risk notification
If a Class II to IV COVID-19 medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available, the authorization holder must report foreign risk information to continue to import or sell the medical device. This information concerns any serious risk of injury to human health that they receive or become aware of and that is relevant to the safety of the device.
Section 68.3 of the MDR requires this reporting for serious risks that occur in specified foreign jurisdictions outlined in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations. This requirement is in line with requirements imposed on MDL holders under Part 1 of the MDR.
Failure to comply with this additional requirement may result in Health Canada cancelling the authorization (paragraph 68.21(1)(a) of the MDR).
To understand and comply with the regulatory requirements for foreign risk notifications, consult the following guidance document:
Biennial/annual summary report
As per section 68.31 of the MDR, once a Class II to IV COVID-19 medical device is removed from the UPHN list or is not included on the UPHN list when the list first becomes available, the authorization holder must prepare summary safety reports on a biennial (Class II) or annual (Class III and IV) basis to continue to import or sell the medical device. This requirement is in line with requirements imposed on MDL holders under Part 1 of the MDR.
Failure to comply with this additional requirement may result in Health Canada cancelling the authorization (paragraph 68.21(1)(a) of the MDR).
To understand and comply with the regulatory requirements for biennial/annual summary reports, consult:
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