COVID-19 guidance for reporting medical device shortages: What happens to your report

Once Health Canada receives a medical device shortage report, we follow up with the manufacturer to ask additional questions about the company's supply and demand. We also confirm whether the:

• report meets the definition of a shortage
• manufacturer has an acceptable substitute option available in Canada

Interim Order No. 2 allows the Minister of Health to compel manufacturers, importers or distributors who import or sell a medical device to provide information within their control about a shortage or potential shortage of the device under certain conditions.

The information that may be requested does not include personal information on a patient, user or any other person whose health or safety may be adversely affected by the medical device being in shortage. (See section 18(3) of Interim Order No. 2.) Requested information is treated as confidential business information and is not shared with any external stakeholders without prior consultation with the company.

We use this information to:

• work with the manufacturer to identify mitigation strategies and
• help inform the procurement of medical devices for Canada

An acceptable substitute option must be available in a sufficient quantity and quality. A suitable option is:

• a Class I device that is sold or imported by an authorized Medical Device Establishment Licence (MDEL) holder or
• a Class II to IV device that is licensed by Health Canada or
• any device that is authorized for sale or import under another interim order made under section 30.1 of the Food and Drugs Act

We will post information about the shortage on the list of shortages i f we determine that the:

• shortage report meets the definition of a shortage and
• reporting manufacturer does not have an acceptable substitute option available for sale in Canada

This information:

• alerts health care facilities and other manufacturers of the supply gaps
• helps health care providers and patients make timely and informed choices about their health
• helps to minimize the impact on patient care

Each device 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 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 number (for Class II, III and IV), if applicable
• 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