ARCHIVED Medical devices for use in relation to COVID-19: Post-market requirements

On January 3, 2024, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need). These regulations broaden the scope of Part 1.1 of the Medical Devices Regulations apply to other public health emergencies. For more information, please refer to the notice.

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Authorization holders will also need to meet post-market requirements for distribution records, complaint handling, incident reporting and recalls. These post-market requirements are similar to requirements previously imposed on authorization holders under IO No. 3, with the exception of complaint handling requirements.

This change was made to address a gap in the application section from IO No. 3, which required documented procedures for handling complaints but did not provide explicit complaint handling requirements.

Incident reporting

Incident reporting by authorization holders

Authorization holders of a COVID-19 medical device must report all incidents that occur in Canada to the Minister:

An incident can include a situation related to a failure of a device or a deterioration in its quality or effectiveness, or any inadequacy in its labelling or in its directions for use.

The preliminary report should describe the incident and the circumstances surrounding the incident. It must include the following:

Each type of problem should be described clearly and any remedial or corrective actions undertaken should be explained.

For information on how to submit an incident report, please consult:

The submission should clearly state that the device is authorized under Part 1.1 of the MDR. It should also provide the authorization number if there is no MDL number.

Following the preliminary report, the authorization holder must submit a final report once the investigation is completed. This applies to all types of incidents.

Mandatory reporting by importers

As per paragraph 68.03(2)(a) of the MDR, importers of an authorized COVID-19 medical device are required to comply with mandatory reporting as outlined in section 59 to 61 of the MDR.

For information on how to comply with these sections, please consult:

Note that new regulations on mandatory reporting under the MDR came into effect on June 23, 2021.

Mandatory reporting for hospitals

As per paragraph 68.03(2)(c) of the MDR, hospitals are required to report all medical device incidents (MDIs) in accordance with section 62 of the MDR. Hospitals may use the MDI online report form to report the MDI.

The mandatory reporting regulatory requirements apply to hospitals that are:

Mandatory reports by hospitals must be submitted in writing within 30 days of the serious MDI being documented. We encourage hospitals to report sooner if possible.

For more information on the reporting requirements for MDIs for hospitals, please consult:

Complaint handling

As per paragraph 68.03(2)(c) of the MDR, authorization holders, importers and distributors must meet post-market requirements related to complaint handling. They are each required to maintain records of:

Authorization holders, importers and distributors must establish and implement documented procedures that will help them investigate problems effectively and quickly and, if necessary, undertake an effective and timely recall of the device.

For more information on complaint handling and an interpretation of these sections, please consult:

Recalls

Devices authorized under Part 1.1 of the MDR are subject to recall provisions (outlined in sections 63 to 65.1). Under these provisions, manufacturers and importers must notify Health Canada on or before recalling their medical device in Canada.

As defined in the MDR, a "recall" is any action taken by the manufacturer, importer or distributor of the medical device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device:

Note: Any device authorized under Part 1.1 of the MDR is also subject to mandatory recall provisions under section 21.3 of the Act. If the Minister believes a medical device presents a serious or imminent risk of injury to health, a person who sells the device may be ordered to:

For guidance on to how to conduct a recall in Canada, please consult:

Discontinuance

A medical device discontinuation occurs when the manufacturer of a Class I to IV medical device decides to discontinue the sale of a specific medical device in Canada. Reasons for discontinuation include a business decision, material availability or facility closure.

Authorization holders must inform the Minister they have discontinued selling their authorized device in Canada, within 30 days of discontinuance (section 68.25 of the MDR).

Shortages

The Minister may add a category of medical devices to the List of Medical Devices – Notification of Shortages (Shortages list) if the Minister has reasonable grounds to believe a shortage of a device in the category presents or may present a risk of injury to human health. This includes COVID-19 medical devices.

Manufacturers and importers must report shortages and discontinuations that may lead to a shortage of medical devices that are on the Shortages list.

Sections 62.21 to 62.26 of the MDR:

Please consult:

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