Notice: Proposed changes to the Medical Devices Regulations to continue the importation and sale of COVID-19 medical devices

Date published: May 2, 2022

This notice is to advise stakeholders that Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). We are making these changes to allow continued access to COVID-19 medical devices when there is an urgent public health need.

On this page

• Overview
• Proposed regulatory amendments to the MDR for COVID-19 medical devices
• Compliance and enforcement
• Feedback and public comments
• Contact us

Overview

Health Canada made 3 interim orders (IOs) to authorize the importation and sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19. These IOs were made to accelerate access to COVID-19 medical devices in Canada during the pandemic. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) took effect on February 21, 2022. It will expire on February 21, 2023. 

We want to maintain a streamlined regulatory process to authorize the importation or sale of these medical devices, while continuing to enforce safety, effectiveness and quality standards.

Health Canada previously communicated to stakeholders the plan to bring forward stand-alone transition regulations that would be in effect for 2 years. However, to ensure stability, we are now proposing to embed regulatory amendments into the MDR. These amendments would keep most of the flexibilities introduced by IO No. 3 for COVID-19 medical devices that have an urgent public health need status.

We are also proposing additional requirements that would allow holders to retain their authorization under the proposed regulations for devices that no longer have an urgent public health need.

Proposed regulatory amendments to the MDR for COVID-19 medical devices

Maintaining IO No. 3 flexibilities

To maintain most of the flexibilities introduced under IO No. 3, the proposed regulatory amendments will seek to do 3 things:

1. Enable manufacturers, importers and distributors to continue to import or sell devices that were authorized under IO No. 3 after its expiry.
   • Manufacturers of Class I, II, III and IV medical devices that have active IO authorizations would keep their authorization if their device meets the criteria of urgent public health need. Once there is no longer an urgent public health need for that device, manufacturers would be required to comply with additional requirements (outlined below) to keep an authorization active under the proposed regulations.
   • The existing expanded use indications permitted under IO No. 3 would continue to be authorized.
2. Enable applications currently in process to be carried over to the proposed regulations without the manufacturer needing to re-submit an application.
   • Applications that were submitted under IO No. 3 will be considered applications for authorization under the proposed regulations.
   • Amendment applications that were submitted for Class I, II, III or IV medical device authorizations under IO No. 3 will be considered amendment applications under the proposed regulations.
   • Requests for information and/or materials that were submitted under IO No. 3 would be considered requests for information and/or materials under the proposed regulations.
3. Provide the same pathway as under IO No. 3 to issue an authorization for:
   • new COVID-19 medical devices that meet the criteria of urgent public health needs, which is determined by multiple factors, including:
     • its supply and demand in Canada
     • its lifecycle (how long it lasts)
     • its clinical need
     • the status of the COVID-19 pandemic in Canada
   • expanded use indications for devices licensed under the MDR, authorized under the IO or these proposed regulations that meet the urgent public health need criteria.
   • COVID-19 medical devices that meet the criteria of urgent public health needs based on the authorization by a trusted foreign regulatory authority.

Alternative evidence on device quality, as specified previously in guidance, would now be required by regulation. Manufacturers would be required to share information with Health Canada, 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. In the absence of a valid ISO 13485:2016 certificate, a completed Quality Checklist (COVID-19 application form for authorization of importation or sale of medical devices), as well as the supporting documentation for each of the criteria in the checklist would be required.

To ensure that COVID-19 medical devices meet safety, effectiveness and quality requirements, the Minister will have similar authorities to IO No. 3 and may at any time:

• impose terms and conditions, or
• ask for more information and/or materials

We monitor the safety and effectiveness of medical devices by identifying and assessing potential safety signals. We use a number of sources to monitor, such as incident reports, published studies and liaising with other regulators. We may ask for more information if there is a concern about the safety or effectiveness of a device. We would cancel an authorization if the authorization holder has not provided enough safety and effectiveness evidence.

NOTE: Importers and distributors must continue to hold a medical device establishment licence (MDEL) and pay the associated MDEL fee and annual renewal fees for as long as they hold a MDEL. Importers, distributors or manufacturers of Class I devices that already hold a MDEL to sell or import devices or a category of devices that meet the urgent public health need criteria would not be eligible to apply for a COVID-19 authorization under the proposed amendments to the regulations.

Other requirements

Under the IO or proposed regulations, authorization holders may import or sell their COVID-19 medical devices even if their device no longer has an urgent public health need status. However, they would need to meet certain conditions. We would communicate to the manufacturer when the device no longer has an urgent public health need.

We would also keep a public list of devices that have urgent public health need status, which would be incorporated by reference into the proposed regulations, as amended from time to time.

Class I COVID-19 medical devices

Authorizations

The manufacturer would need to apply for a MDEL within 120 days (application period) of the date that the device is no longer considered to have an urgent public health need. While transitioning to a MDEL, authorizations would remain active under the proposed regulations.

If a Class I manufacturer does not apply for a MDEL within the 120-day application period, Health Canada would cancel the authorization.

Requirement to pay applicable fees

To keep their authorization, Class I manufacturers would also need to pay all associated fees within 1 year of the date that the device no longer has urgent public health need status.

Some establishments may be eligible for small business fee mitigation, where the full fee is reduced by 25%.

Penalties and accountability standards for Class I COVID-19 MDEL applications would stay the same as those set out in the performance standards for the Fees Order.

Class II, III and IV COVID-19 medical devices

Quality management system (QMS) certificate issued under the Medical Device Single Audit Program (MDSAP)

Once the device no longer meets the urgent public health need criteria, to keep their authorization, Class II to IV authorization holders would need to:

• initiate the certification process under the MDSAP
• submit a certification contract (signed by both the manufacturer and the auditing organization) within 120 days of the date that the device no longer has urgent public health need status
• submit a copy of their QMS certificate issued under MDSAP within 2 years of the date that the device no longer has urgent public health need status

Manufacturers of Class II COVID-19 medical devices would be required to submit a copy of the QMS certificate certifying that the quality management system under which the device is manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

Manufacturers of Class III and IV COVID-19 medical devices would be required to submit a copy of the QMS certificate certifying that the quality management system under which the device is designed and manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

Authorizations would remain active under the proposed regulations:

• while the manufacturer is in the certification process under the MDSAP
• once the manufacturer has obtained and submitted the certificate to Health Canada

Authorizations would be cancelled for manufacturers who do not submit a certification contract (signed by both the manufacturer and the auditing organization) within 120 days of the date that the device no longer has urgent public health need status and provide the QMS certificate within the 2-year timeframe.

Annual authorization renewal

Every year, authorization holders would need to provide us with:

• a list of authorized devices that are currently on the market
• the authorization number and class for each device

Existing authorizations under the proposed regulations may be cancelled for failure to comply.

Requirement to pay applicable fees

Once a device no longer has urgent public health need status, the manufacturer would be required to pay fees that apply:  

• existing evaluation fees for subsequent filings for any amendments
• existing “medical device right to sell fee”, which is charged each year for the 12-month period beginning on November 1

Small businesses of medical devices that had urgent public health need status at one time may qualify for help with the fees. Health Canada’s mitigation measures include:

• receiving a first ever Pre-market Evaluation submission / application / notification for free offering a 50% reduction in all upcoming evaluation fees, or
• offering a 25% reduction for all Establishment Licence Fees

Penalties and accountability standards for medical device applications no longer having urgent public health need status would remain. They are set out in the performance standards for the Fees Order.

All medical devices classes

Refusal

The Minister may refuse an application, amendment or expanded use indication if there is not enough evidence of an urgent public health need for the device.

Mandatory incident reporting

Health Canada is proposing to change the timing of incident reporting so incidents that are more serious are dealt with first. This change is in keeping with the MDR.

Manufacturers would have 10 days to report on incidents that:

• involve a failure of the device or a deterioration in its quality or effectiveness
• indicate the labelling or directions for use are inadequate, and
• have led to the death or a serious deterioration in the health of a patient, user or other person

Manufacturers would now have 30 days to report on incidents that:

• involve a failure of the device or a deterioration in its quality or effectiveness
• indicate the labelling or directions for use are inadequate, and
• have not led to the death or a serious deterioration in the health of a patient, user or other person but could do so were it to recur

Manufacturers should submit a preliminary report to Health Canada within 10 or 30 days as required, followed by a final report once the investigation is completed.

Cancellation

Once an authorization is cancelled:

• manufacturers would no longer be able to sell products authorized under the proposed regulations; and
• distributors and importers would have a 6-month timeframe to deplete existing stock (i.e., a sell off period).

Compliance and enforcement

For medical devices authorized under this pathway, Health Canada would continue to follow the Compliance and Enforcement Policy (POL-0001) to

• promote and monitor compliance, and
• undertake enforcement activities.

Feedback and public comments

We sought feedback from stakeholders on this regulatory proposal.

In particular:

• If you have terms and conditions on the authorization of your medical device under the interim order, provide the number of terms and conditions by class on a per product basis.
• Indicate whether you currently have a QMS certificate issued under MDSAP under the MDR.
• If you have a QMS certificate issued under MDSAP under the MDR, indicate the costs and processes for obtaining one and how long it took to get a certificate.
• If you don’t have a QMS certificate issued under MDSAP, indicate your anticipated costs and processes for obtaining one.
• Based upon what is described in the proposal, indicate whether you would continue to market your COVID-19 product in the Canadian market.
• Indicate the factors that will contribute to your decision to continue or discontinue that product.

The consultation was open for 21 days, ending May 22, 2022. The input received will help us refine the proposal and develop the related content.

• Consultation on new regulations to import and sell COVID-19 medical devices

Contact us

For more information on medical device establishment licensing, please contact us by email at mdel.questions.leim@hc-sc.gc.ca.

Related links

• Authorized devices for uses related to COVID-19: Overview