Draft guidance for reporting medical device shortages: What happens to your report
Health Canada has made the medical device shortage reporting framework permanent by transitioning interim order provisions to the regulations. The interim order expired on March 1, 2022, at which time the new shortage reporting framework took effect. For more information, visit the Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice
Manufacturers of a Class I to IV device or Class I importers are responsible for sending a medical device shortage report and summary information to Health Canada. We will review this information to determine if the reported shortage meets the statutory definition of a shortage.
We will post information about confirmed medical device shortages on the Medical device shortages - List of shortages (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 medical device shortages is linked to a detailed report. The reports contain the following information:
- type and status of the shortage (actual, anticipated, resolved, avoided)
- name of medical device as well as any component, accessory or part that is in shortage, including the model name
- other names (for example, trade name)
- anticipated or actual start date of shortage
- estimated end date of shortage
- reason for the shortage
- names of importers listed who have reported the shortage 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.
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