Guide for recalling medical devices (GUI-0054): Ordered recall reporting

Guidance for ordered recalls

This section outlines the Medical Devices Regulations (regulations) that relates to Health Canada ordering a company or a person to report a recall.

Section 65.2(1)

Section 65.2(1) of the regulations states:

Sections 65.2 (1) applies to any person who is ordered by the minister to recall a medical device.

If information indicates that a medical device presents a serious and imminent risk of injury to health, Health Canada may issue an order to recall to mitigate the risk to public health. An example would be when a person or a company refuses to conduct a voluntary recall.

The person or company ordered to recall a medical device will submit information required under 65.2(1) in the time and manner specified by the Minister.

Before you begin the recall, you must submit a:

• written notification in the manner specified by the Minister within 24 hours of starting the recall
  • include any additional information as described in the recall order
• copy of the recall communication you intend to send to consignees at the beginning of the recall

During the recall, you must provide any:

• additional communications sent out after the recall began
• progress reports (as applicable) as requested in the recall order
• changes to the contact person responsible for managing the recall order
• written notification within 24 hours in the manner specified by the recall order before completing a recall

As per section 65.2(5), you must submit a final recall report within 30 calendar days of completing the recall.

How to write ordered recall reports

Initial recall order information

Section 65.2(1) states:

A person who is ordered by the Minister to recall a medical device shall provide the Minister with the following information in the time and manner specified by the Minister:

1. the name and address of:
   1. the manufacturer of the device
   2. the establishment where the device was manufactured, if different from that of the manufacturer
   3. importer of the device and
   4. the person who sold them the device, if the person who is conducting the recall is not a manufacturer
2. the nature of the defectiveness or possible defectiveness of the device and the date on which and the circumstances under which the defectiveness or possible defectiveness was discovered
3. the number of affected units of the device that the person:
   1. manufactured in Canada
   2. imported into Canada and
   3. sold in Canada
4. the number of affected units of the device in Canada that are in the possession or control of the person
5. the period during which the affected units of the device were distributed in Canada by the person
6. the number of affected units of the device that have been sold by the person at the retail level to consumers in Canada
7. if the person has sold the affected device to persons in Canada other than consumers referred to in subparagraph (f), the names of those persons and the number of units of the sold to each of them
8. the proposed strategy for conducting the recall, including:
   1. the date for beginning the recall
   2. the time and manner in which the Minister will be informed of the progress of the recall and
   3. the proposed date for its completion
9. the proposed action to prevent a recurrence of the problem
10. the name, title and contact information of the representative of the person to contact for information concerning the recall and
11. any other information that the Minister has reasonable grounds to believe is necessary to reduce the risk of injury to health

Final recall order information

Section 65.2(5) states:

The person shall, within 30 days after completing the recall, provide the Minister with the following information, in writing:

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

Note: The recall order may contain additional instructions or requests not outlined in this guide on how to fulfill the requirements of the order.