Guidance on Medical devices for an urgent public health need: Post-market requirements

On this page

• Incident reporting
• Complaint handling
• Recalls
• Discontinuance
• Shortages

Authorization holders will also need to meet post-market requirements for distribution records, complaint handling, incident reporting and recalls.

The post-market requirements on this page apply to manufacturers, importers and distributors of UPHN medical devices. (Note: UPHN refers to urgent public health need).

For post-market requirements that apply to manufacturers, importers and distributors of medical devices that are not UPHN medical devices, refer to the additional requirements.

Incident reporting

Incident reporting by authorization holders

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

• within 10 days of becoming aware, if the incident has led to the death or serious deterioration in the state of health of a patient, user or other person or
• within 30 days of becoming aware, if the incident has not led to the death or serious deterioration in the state of health of a patient, user or other person but could if the incident were to recur

An incident can include a situation concerning:

• 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:

• name of the medical device and its identifier
  • includes the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family
• names and addresses of the holder and known importers of the medical device, and name, title and contact information of the holder's representative
  • to contact for information on the incident
• date when the holder became aware of the incident
• details about the incident, including date when the incident occurred and the consequences for the patient or user
• name and contact information, if known, of the person who reported the incident to the holder
• names of other medical devices involved in the incident, including any accessories, if known
• preliminary comments on the incident from the holder
• course of action, including an investigation, the holder proposes to follow and a timetable for carrying out this action and for submitting a final report
• statement on whether a previous report has been made to the Minister about the medical device and, if so, the date of the report

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, consult:

• Mandatory medical device problem reporting form for industry

The submission should clearly state that the device is authorized under Part 1.1 of the Medical Devices Regulations (MDR). It should also provide the authorization number if there is no medical device licence (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 medical device must comply with mandatory reporting as outlined in sections 59 to 61 of the MDR.

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

• Guidance document for mandatory problem reporting for medical devices

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:

• licensed, approved or designated as a hospital by a province or territory to provide care or treatment
• operated by the Government of Canada and provide health services to in-patients

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

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

• Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals

Complaint handling

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

• reported problems on the performance or safety of the device
  • includes consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada
• all actions taken by the manufacturer, importer or distributor in response to the problems

Authorization holders, importers and distributors must establish and implement documented procedures that will help them:

• investigate problems effectively and quickly and
• undertake an effective and timely recall of the device, if necessary

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

• Guidance on investigation of reported medical device problems (GUI-0065)

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
• notify its owners and users of its defectiveness or potential defectiveness

The manufacturer, importer or distributor is required to take action after becoming aware that the device may:

• be hazardous to health
• fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety or
• not meet the requirements of the Food and Drugs Act (act) or the MDR

• recall the product or
• send the product to a place specified in the order

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

• Guide to recall of medical devices (GUI-0054)

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 medical devices for which there is an urgent public health need.

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:

• require manufacturers of Class I to IV medical devices and importers of Class I medical devices to report shortages of devices (including their components, accessories and parts) that are on the shortages list
• require manufacturers or designated importers to report if the manufacturer is discontinuing the sale of a specified medical device in Canada and the discontinuation may cause a shortage
• permit the Minister of Health to require a manufacturer, importer or distributor to provide information requested about a medical device shortage

For more information on shortages, please consult:

• Guide to reporting medical device shortages and discontinuations