Guide for recalling medical devices (GUI-0054): Recall records

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• Guidance for keeping recall records
• Retention time

Guidance for keeping recall records

This section outlines the Medical Devices Regulations (regulations) that relate to keeping records for recalls.

Record keeping for manufacturers and importers

Section 65.3 of the regulations states:

A manufacturer or importer of a medical device that recalls the device without being ordered to do so by the Minister, shall keep a record of the following information and documents:

1. the decision to conduct the recall, including:
   1. the name and title of any individual who made the decision and
   2. the date the decision was made
2. the date the recall was completed
3. the information and documents referred to in sections 63.2, 64 and 65 and
4. the fact that the importer has prepared and submitted the information and documents to the Minister on behalf of the manufacturer in accordance with subsection 65.1(2), as the case may be

All pertinent information related to the recall should be maintained with the recall record. Information may include the following information:

• decision to initiate as well as closure of a recall, including the identification of whom made the decisions
• health risk evaluation
• 24-hour recall notification (section 63.2)
• records of communication with customers and/or relevant stakeholders, including attempts made to contact such people.
  • would also include records of customer responses, such as customer responses forms and reconciliation logs
• information required under sections 64 and 65

Note: The recall record requirements also apply to non-reportable recalls.

Record keeping for distributors

Section 65.4(1) states:

Subject to subsection (2), if a distributor of a medical device conducts a recall of the device that was not ordered by the Minister, the distributor shall keep a record of the following information and documents:

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
   3. the importer and
   4. the person who sold them the device
6. 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
7. the number of affected units of the device that the distributor sold in Canada
8. the period during which the affected units of the device were distributed in Canada by the distributor
9. the name of each person to whom the affected device was sold by the distributor and the number of units of the device sold to each person
10. a copy of any communication issued with respect to the recall
11. the results of the recall and
12. the date the recall was completed

Distributors do not have to report recalls as per section 64, but do have to keep recall records as per section 65.4(1). This applies regardless of who initiated the recall.

Distributors who initiate a recall must also keep records of the following:

• evaluation of the risk associated with the defectiveness or possible defectiveness
• actions that were proposed and taken to prevent the problem from occurring again

Retention time

Section 65.6 states:

1. The manufacturer who is required to keep a record under sections 65.3 or 65.5 shall keep it for at least the longer of the following periods:
   1. the period this is equivalent to the projected useful life of the medical device plus to which the recall related plus 2 years and
   2. the period during which the device is being sold Canada
2. Any other person who is required to keep a record under section 65.3, 65.4 or 65.5 shall keep it for at least a period equivalent to the projected useful life of the device to which the recall relates plus 2 years
3. For the purpose of paragraph (1)(a) and subsection (2), the retention period begins on the day the recall is completed.

The manufacturer should determine the projected useful life of the device.

The purpose of the manufacturer maintaining recall records is to maintain historical data of safety and compliance of the device. Recall records make it possible for us to verify a company's recall process. We may use recall records to confirm if recalls are properly classified, as some are not reportable.

Your recall procedures should define how long to keep recall records.