Guide to reporting medical device shortages and discontinuations: What happens to your report
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Manufacturers and importers are responsible for sending medical device shortage and discontinuation reports to Health Canada. We will review this information to determine if the reported shortage meets the statutory definition of a shortage and similarly, if a reported discontinuation meets the definition of a discontinuation.
We will post certain information about confirmed medical device shortages and discontinuations on the List of shortages and discontinuations (section 62.25).
This information is used to:
- alert health care facilities and other manufacturers of supply gaps
- help health care providers and patients make timely and informed choices about their health
- help minimize the impact of a shortage on patient care
Each device posted on the List of shortages and discontinuations is linked to a detailed report. The reports contain the following information:
- type and status of the shortage/discontinuation (actual, anticipated, resolved, avoided, discontinued, to be discontinued)
- name of medical device in English and French, as well as any component, accessory or part, including the model name
- other names (for example, trade name)
- anticipated or actual start date of shortage/discontinuation
- estimated end date of shortage
- reason for the shortage/discontinuation
- names of importers listed who have reported the shortage/discontinuation separately from the manufacturer or are reporting on behalf of the manufacturer in a delegated capacity
- description of the device
- package description (for example, packaging formats, sizes, quantities)
- single-use product
- class of medical device (I, II, III or IV)
- device identifiers (for example, catalogue number, part number, model number or unique device identifier)
- medical device licence (MDL) number for the applicable Class II, III and IV device
- authorization identification number for devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act, if applicable
- manufacturer's name and mailing address
Additional information used to confirm the existence of a shortage is not posted on the report online.
Health Canada actively monitors the status of reported shortages and discontinuations and regularly updates the List of shortages and discontinuations as information is received from the manufacturer or importer.
However, the detailed reports that are linked from this list, which include specific information related to the device that is in shortage or discontinued, will not be updated.
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