Guidance on medical device establishment licensing (GUI-0016): Other regulatory requirements

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• Maintaining records
• Reporting problems
• Recalls
• Reporting shortages and discontinuations

This section outlines some of the key responsibilities of a medical device establishment licence (MDEL) holder

Maintaining records

Distribution records

Manufacturers, importers, and distributors of a medical device must each maintain a distribution record for each device. You must also have a documented procedure in place for how you maintain your distribution records, as you attested to in your application for an MDEL.

Your distribution record must contain enough information so that you can quickly withdraw any medical device completely from the market. Your procedures should specify how long you retain your distribution records and how they will be maintained.

Note: Section 55 of the MDR specifies that manufacturers, importers, and distributors shall retain the distribution record maintained in respect of a medical device for the longer of:

• the projected useful life of the device and
• 2 years after the date the device is shipped

Refer to sections 52 to 56 of the MDR for more information on distribution record requirements, including minimum retention periods for distribution records and how to maintain records to allow for quick retrieval.

Complaint handling

Manufacturers, importers, and distributors must also maintain records of reported problems concerning the performance or safety for all medical devices they have sold. These records must include all actions taken to respond to these problems. You must also have documented procedures for handling complaints.

For more information on complaint handling, consult:

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

Reporting problems

Importers and manufacturers of medical devices must provide both a preliminary and a final report to Health Canada about:

• devices that they sold in Canada for which incidents that took place inside Canada have been brought to their attention or
• Class I devices for which incidents that took place inside or outside Canada have been brought to their attention and
• the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action or the regulatory agency has required the manufacturer to take corrective action

To avoid duplicate reporting, the manufacturer of the device may allow the importer to prepare and submit the preliminary and final reports on the manufacturer's behalf if the information that must be included is identical. The manufacturer must inform us, in writing, if such permission has been granted to the importer.

However, a manufacturer may not prepare and submit a report on behalf of an importer.

For more information on the types of incidents that must be reported and what to include in the report, consult the following guidance document:

• Incident reporting for medical devices

Serious risk of injury to human health

Importers and manufacturers of Class II, III or IV medical devices must submit information to Health Canada within 72 hours after they receive or learn of information concerning a serious risk of injury to human health that is relevant to the safety of the device.

The manufacturer of a medical device may permit the importer of the device to prepare and submit the information on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical. The manufacturer must inform us, in writing, if such permission has been granted to the importer.

However, a manufacturer may not prepare and submit a report on behalf of an importer.

For more information on the types of incidents that must be reported and what to include in the report, consult the following guidance document:

• Foreign risk notification for medical devices

Recalls

Medical device manufacturers, importers and distributors must have documented procedures for recalls.

When they recall a medical device, the manufacturer and importer of that device must each send a report to Health Canada, on or before the recall. This report must outline the information specified in sections 64 and 65 of the MDR. Distributors should comply with section 45(g) and conduct a recall when required.

As soon as possible after completing a recall, both the manufacturer and importer must each report to Health Canada the results of the recall and the actions taken to prevent a recurrence of the problem. A manufacturer may allow the importer to submit the information and documents relating to the recall on its behalf by notifying Health Canada in writing if the information that must be submitted is identical for both of them.

For more information on recall requirements, consult: 

• Recall policy for health products (POL-0016)
• Guide to recall of medical devices (GUI-0054)

Reporting shortages and discontinuations

Health Canada recommends that manufacturers and importers develop internal written procedures for reporting medical device shortages and discontinuations. This should be part of your internal quality management system.

When developing these procedures, you should consider the following:

• our medical device shortage reporting requirements
• which department is responsible for reporting shortages to us
• the timelines required for initial shortage reports, updates, avoided shortages, shortage closures and device discontinuations
• a procedure for checking the List of medical devices - Notification of shortages regularly to ensure you are reporting all mandatory medical device shortages
• subscribing to our Medical Devices Compliance Program bulletins to ensure your company is up to date on the latest developments on shortage and discontinuation reporting
• risk mitigation steps to be taken to address medical device shortages in your organization

If you have questions about medical device shortage and discontinuation reporting, please email the Medical Device Shortages Unit at:
MD.shortages.penurie.de.IM@hc-sc.gc.ca.

For more information on shortages reporting requirements, consult:

• Guide to reporting medical device shortages and discontinuations (GUI-0137)