Guide for recalling medical devices (GUI-0054): Recall reporting and process

On this page

• Reportability of recalls
• Guidance for recall reports
• How to write recall reports

Reportability of recalls

Section 63.1 of the Medical Devices Regulations (regulations) states:

Sections 63.2, 64 and 65 apply to a manufacturer or importer of a medical device if the device is likely to cause injury to the health of a patient, user or other person, or could cause serious injury to the health of a patient, user or other person.

Note: If a recall is not reportable, none of the notification (section 63.2) and recall reports (sections 64 to 65) have to be submitted to Health Canada. However, the steps outlined in the recall process page still apply to non-reportable recalls. Non-reportable recalls should be conducted as if they were reportable.

Type I and II recalls as defined in this guidance document are reportable. The reportability of a recall depends on the severity and probability of harm. It's the responsibility of the regulated party to determine the recall type based on device and its risk profile. If the device affected by a recall is not likely to cause injury to health, that recall does not need to be reported. Recalls involving unlicensed devices are expected to be reported to Health Canada as these devices have not been reviewed for their safety and efficacy and they could cause serious injury to patient, users or other person.

If your risk evaluation matrix deems a recall to be a type III, it may still be reportable to us as per section 63.1. If the device affected by the recall could cause serious injury to the health, the recall must be reported regardless of probability of occurrence.

If the company conducting the recall is unsure about the reportability of a recall, it can be reported as a precautionary measure. Reportable recalls are listed on Health Canada's recall and safety alerts.

Find recalls, advisories and safety alerts

Guidance for recall reports

If you manufacture or import medical devices sold in Canada, the recall reporting requirements apply to you. These requirements are set out in this section.

Section 63

Sections 63.2, 64 and 65 do not apply to a:

• retailer
• health care facility where a medical device is distributed for use within the facility

Section 63.2 regarding 24-hour notification to Health Canada applies to manufacturers and importers. If you're a manufacturer or an importer, your recall procedures should include information on how to write the initial notification to Health Canada. Your procedures should specify the:

• specific content required for the initial notification
• timeframe for submitting the initial recall notification

The preliminary risk assessment should contain as much information as possible on the risk associated with the device's defectiveness (or possible defectiveness) at the time the decision is made to initiate a recall. The complete risk assessment can be provided when you submit the information required under section 64 of the regulations.

Sections 64 and 65

Your recall procedures should include information to help write the initial and final recall reports that are submitted to Health Canada. Your procedures should specify the:

• specific content required in these initial and final recall reports (sections 64 and 65)
• timeframe and contact details for submitting these reports
• need for progress reports, if requested by Health Canada

Submitting your reports

Submit the 24-hour notification of a recall and recall reports.

Email: meddev-matmed@hc-sc.gc.ca

Notification

As per section 63.2 of the regulations, an initial notification must be submitted within 24 hours of deciding to conduct a recall in Canada.

To submit a recall report, follow these guidelines:

1. Submit the initial recall report on or before starting the recall. The start date of the recall is when you begin sending out recall notifications (for example, the date on the recall notification letter). The report is to include all the information requested in section 64 of the regulations. You can also use the initial recall reporting form (FRM-0360) to complete your initial recall report.
2. Submit the final recall report within 30 calendar days after completing the recall. The report is to include all the information requested in section 65 of the regulations. You can also use the final recall reporting form (FRM-0360) to complete your final recall report.

Medical Device Recall Reporting Form – Initial (FRM-0360A)
Medical Device Recall Reporting Form – Final (FRM-0360B)

Section 65.1

Section 65.1 states:

1. Despite sections 64 and 65, the manufacturer of a medical device may permit the importer of the device to prepare and submit, on the manufacturer's behalf, the information and documents with respect to the recall if the information and documents that the manufacturer and importer must submit are identical.
2. The manufacturer shall advise Health Canada in writing if the manufacturer has permitted the importer to prepare and submit the information and documents with respect to the recall on the manufacturer's behalf.

Both the manufacturer and the importer are required to submit recall reports, unless the manufacturer designates an importer to report on their behalf. The manufacturer may only designate the sole importer of the device in Canada, and the information the importer submits must be identical to that of the manufacturer.

If you're a manufacturer and you want to designate an importer to submit a recall report on your behalf, you must ensure the importer understands the recall reporting requirements. Once designated, the importer will provide all recall information required by sections 64 and 65 of the regulations.

Manufacturers must submit a written notification to Health Canada confirming that the importer accepts the recall report designation.

Email: meddev-matmed@hc-sc.gc.ca

Interim or progress reports

After reviewing your initial recall report, we may ask you to submit interim or progress reports at agreed-upon intervals. Interim reports are normally requested for recalls that:

• have multiple stages
• have long projected completion dates
• are not completed by the projected date

Recall progress reports contain the following:

• number of consignees notified of the recall
• date and method of notification
• number of respondents and quantity of affected devices in their possession
• number of non-respondents (we may request their identity)
• number of devices returned or corrected
• number and results of recall effectiveness checks
• estimated timeframe for completion (if revised)

How to write recall reports

Under sections 63.2, 64, 65 and 65.2 (1) of the regulations, manufacturers and importers must submit reports to Health Canada giving details about their medical device recall process. Your reports must contain the following information:

Section 63.2: Recall notification

This section states:

A manufacturer or importer of a medical device that decides to recall the device without being ordered to do so by the Minister, shall provide the Minister with the following information, in writing, within 24 hours after making the decision:

1. the name of the device and its identifier, including 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
2. in the case of a licensed device, the medical device licence number
3. in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number
4. the name and address of:
   1. the manufacturer
   2. the establishment where the device was manufactured, if different from that of the manufacturer, and
   3. the importer
5. the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which the defectiveness or possible defectiveness was discovered
6. a preliminary evaluation of the risk associated with the defectiveness or possible defectiveness

To fulfill section 63.2 requirements, follow these guidelines when writing your recall notification:

• Describe the device being recalled as completely as possible in your notification. Include the medical device's:
  • licensed name
  • identifier (for example, catalogue number, product code, bar code)
  • licence number, if applicable
  • authorization number (under section 68.12), if applicable
• Identify the device's manufacturer and importer. Report the full name and address of the manufacturer (found on the device's label) and of the importer (if applicable). Include the street address and postal or ZIP code. If the device was fabricated at a site different from that of the manufacturer, also provide the full name and address of the contract manufacturer.
• Describe the problem or potential problem with the device at that time. Additional information about the problem that has led to a recall action can be provided with the initial recall report (section 64) or upon Health Canada request.
• Describe the preliminary risk associated with using the device in its defective state and the likelihood that it could injure users. Include as much information available at that time.

Section 64: Initial recall report

This section states:

A manufacturer or importer of a medical device that recalls the device without being ordered to do so by the Minister, shall provide the Minister with the following information and documents, in writing, on or before undertaking a recall of the device:

1. the name of the device
2. the identifier of the device, including 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
3. in the case of a licensed device, the medical device licence number
4. in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number
5. the name and address of:
   1. the manufacturer
   2. the establishment where the device was manufactured, if different from that of the manufacturer, and
   3. the importer
6. the reason for the recall, the nature of the defectiveness or the possible defectiveness and the date on and circumstances under which the defectiveness or possible defectiveness was discovered
7. an evaluation of the risk associated with the defectiveness or possible defectiveness
8. the number of affected units of the device that the manufacturer or importer:
   1. manufactured in Canada
   2. imported into Canada
   3. sold in Canada
9. the period during which the affected units of the device were distributed in Canada by the manufacturer or importer
10. the name of each person to whom the affected device was sold by the manufacturer or importer and the number of units sold to each person
11. a copy of any communication issued with respect to the recall
12. the proposed strategy for conduction the recall, including
    1. the date for beginning the recall
    2. information as to how and when the Minister will be informed of the progress of the recall and
    3. the proposed date for its completion
13. the proposed action to prevent a recurrence of the problem and
14. the name, title and contact information of the representative of the manufacturer or importer to contact for any information concerning the recall

To fulfill section 64 requirements, follow these guidelines when writing your initial report:

• Describe the device being recalled as completely as possible in your initial report. Include the medical device's:
  • licensed name
  • identifier (for example, catalogue number, product code, bar code)
  • lot number, batch number or serial number
  • licence number
• Identify the device's manufacturer and importer. Report the full name and address of the manufacturer (found on the device's label) and of the importer (if applicable). Include the street address and postal or ZIP code. If the device was fabricated at a site different from that of the manufacturer, also provide the full name and address of the contract manufacturer.
• Describe the problem or potential problem with the device. Keep the description to 50 words or less in both official languages (French and English). Attach additional information that must be provided as per section 64 (such as the date you discovered the problem and how you found out about it, any death or injury resulting from the problem or defect) separately.
• Describe the risk associated with using the device in its defective state and the likelihood that it could injure users.

Remember to assign a level of risk to each recall.

Your initial report should also:

• account for all affected units of product
  • State the number of units that remain in the manufacturer or importer's stock. If more than 1 medical device is involved in the recall, provide numbers of affected units for each.
• indicate the distribution period for the device
  • At a minimum, report the dates of the first and last sale of the device in its defective state. If more than 1 medical device is involved, include each distribution period separately.
• indicate each person to whom the device was sold
  • Include the:
    • name and contact information for each person or company
    • number of units distributed to that person or company
    • name of each individual to whom you provided the recall information
  • For example, if the device was sold to a hospital, provide the name and contact information for each individual in the hospital who received the recall notice.

Attach copies of all documented communications about the recall in both official languages, including:

• letters or written notices to consignees
• acknowledgment forms
• public notices or press releases
• notices to professional associations

Include specific information about how you plan to conduct the recall, such as the dates it will begin and close. You must provide a rationale if you expect the recall to be completed more than 3 months after your initial notice to Health Canada.

Describe how you plan to prevent the problem or potential problem from happening again. Include an analysis of the issue's root cause (if known) and the scope of affected production. If you do not yet have a detailed plan, indicate where you will focus efforts in understanding and resolving the problem.

Provide contact information for your company. Specify a representative who is easy to reach and knows the recall process. If possible, provide a fax number or email address with the contact's name, title and telephone number. If the recall has been assigned a Type I risk rating, this person should be available on a 24-hour basis.

Section 65: Final recall report

Section 65 states:

The manufacturer and importer of a medical device shall, within 30 calendar days after the completion of a recall, each report to Health Canada:

1. the results of the recall
2. the action taken to prevent a recurrence of the problem

Manufacturers and importers must submit a written report upon completion of the recall. Your report should include the following details:

• number of recovered units
• number of units used by consignees
• number of units destroyed by consignees (as requested in the recall notice)
• number of units corrected (modified, repaired or retrofitted), either on site or off site, and returned to consignees
• number of units that were not located
• how you intend to dispose of any recovered units or stock units
  • evidence of disposition must be available upon request
• final date the recall was completed
• assurance that all consignees received the recall information
  • evidence must be available upon request
• detailed plan of how you corrected the problem and how you will prevent it from happening again
  • for example, design change, process validation or increased quality control
• results of your licence amendment review and, if applicable, confirmation of the licence amendment application