Guidance on Medical devices for an urgent public health need: Additional Requirements
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 List of medical devices for an urgent public health need (UPHN list) is an ambulatory list incorporated by reference. It may be amended from time to time.
Health Canada will continue to assess the urgent public health need of UPHN medical devices, taking into account the state of the public health emergency. This approach allows us to:
- focus resources on reviewing applications for devices that people in Canada still urgently require
- communicate to industry any gaps that exist in categories of authorized devices
Note: UPHN refers to urgent public health need.
An amendment to the UPHN list may result in a device being removed from Part 1 of the list or a category of devices being removed from Part 2 of the list. For a device or a category of a devices to be on the UPHN list, the Minister must have reasonable grounds to believe there is an urgent public health need for that device or that category of devices in relation to a corresponding medical condition on the list.
Removal of a listing from the UPHN list
The UPHN list is archived every time there is a change.
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.
For medical devices that cease to be a UPHN medical device while the application for authorization is in queue, the day that the device ceases to be a UPHN medical device is the day the Minister issued the authorization. This means that the manufacturer would be subject to the additional requirements the day the authorization may be issued.
We will contact manufacturers with authorizations under Part 1.1 of the Medical Devices Regulations (MDR) who are affected by the listing being removed.
Requirements for Class I device manufacturers
Manufacturers of Class I medical devices that hold an authorization under Part 1.1 are not required to hold a medical device establishment licence (MDEL). However, this exemption only applies as long as the medical device is a UPHN medical device.
When a medical device is no longer a UPHN medical device, the authorization holder will need to comply with Part 1 of the MDR if they wish to continue importing or selling their Class I medical device in Canada.
Requirement to apply for a medical device establishment licence
The authorization holder of a Class I medical device will have 120 days after the day on which the medical device is removed from the UPHN list to apply for an MDEL. Or, they may 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, 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, 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 added back onto the UPHN list after the manufacturer started paying fees, fees do not apply from that time until the device is removed from the 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 not apply. The holder would need to ask Health Canada to stop processing their request for an MDEL.
- If a holder received their MDEL under 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, consult the following guidance document:
Requirements for Class II to IV device manufacturers
Manufacturers of Class II to IV medical devices can maintain their 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.
Quality management system (QMS) certificate requirements
To remain authorized under Part 1.1 of the MDR after a Class II to IV medical device is removed from the UPHN list, 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 list, to indicate the certification process under Medical Device Single Audit Program (MDSAP) has been initiated
- 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 medical device is removed from the list
Authorization holders of Class II, III and IV medical devices must submit a copy of the QMS certificate.
The QMS certificate certifies that the QMS meets the requirements of the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes:
- for Class II devices, under which the device is manufactured (paragraph 32(2)(f) of the MDR)
- for Class III and IV devices, under which the device is designed and manufactured (paragraphs 32(3)(j) and 32(4)(p) of the MDR)
This standard is amended from time to time.
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, the holder may decide to stop or continue the certification process. However, Health Canada will not reimburse any paid fees.
Payment of fees
The manufacturer must pay certain fees to maintain their authorization of a Class II, III or IV medical device if the device or category of medical device that the device belongs to is:
- not on the UPHN list or
- subsequently removed from the UPHN list
Moreover, once a device is not a UPHN medical device:
- any amendments to the device authorization would require the existing applicable amendment examination fees to be paid
- the manufacturer 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 list. Health Canada will not reimburse paid fees or charge fees retroactively.
For more information, consult the following guidance document:
Annual review
Authorization holders of Class II to IV medical devices will be subject to annual review requirements if they wish to continue importing and selling their device once it is not a UPHN medical device. This is outlined in section 68.24 of the MDR. 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 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
Failure to comply with this additional requirement may result in Health Canada cancelling the authorization (paragraph 68.21(1)(a) of the MDR).
Foreign risk notification
If a Class II to IV medical device is removed from the UPHN list, the authorization holder and importer of the device 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 medical device licence (MDL) holders under Part 1 of the MDR.
The authorization holder and the importer must submit this information to the Minister within 72 hours after they receive or become aware of it. However, as per section 68.301, an authorization holder who is also the manufacturer may permit the importer of the device to submit the information required on their behalf. This can only occur if the information is identical and if the manufacturer informs the Minister that they have permitted this.
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 medical device is removed from the UPHN list, 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:
Page details
- Date modified: