Report a medical device shortage

Manufacturers of Class I to IV medical devices and importers of Class I medical devices must report medical device shortages for devices that are on the List of Medical Devices – Notification of Shortages by completing the form below.

Privacy notice statement

Personal information is collected under the authority of the Food and Drugs Act and the Privacy Act for the purpose of delivering the mandatory shortage reporting program for medical devices under the Health Canada mandate.

Your personal information when disclosed to the Health Canada is confidential and protected. This information is administered and retained in accordance with the Food and Drugs Act and is protected as personal information under the Privacy Act, and in the case of an access to information request, under the Access to Information Act. Your personal information is stored and maintained in an appropriate database and / or filed in accordance with the department's best practices.

Please note that for shortages posted on the Medical device shortages: List of shortages website, the company name of the importer who reports the medical devices shortages will be published in the table with the manufacturer's name for specified medical device(s) on Health Canada's website.

You have the right to access your personal information and request changes if the information is incorrect. Questions or comments regarding the administration of the Privacy Act in our Department may be directed to the Health Canada's Access to Information and Privacy Coordinator. For additional information on privacy issues and the Privacy Act in general, consult the Office of the Privacy Commissioner of Canada or call 1 800-282-1376 or 819-994-5444.

Shortage information

Shortage Report Number(s), if applicable^{Footnote 1}

Type of report(s)^{Footnote 2}

Mandatory

Voluntary

Unknown

Status of report(s)

Initial

Update

Type of shortage(s)

Anticipated medical device shortage

Actual medical device shortage

Scope of shortage(s)

National

Provincial or territorial

Unknown

Name of medical device (including any component, accessory or part) that is in shortage, including the model name, if applicable, in English ^{Footnote 3} (required)

Name of medical device (including any component, accessory or part) that is in shortage, including the model name, if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities) (required)

Description of the device: Single-use product (required)

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4} (required)

Medical device licence number(s) (for Class II, III and IV) (required)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s)

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act (required)
Note: Please indicate N/A for Class II, III and IV devices that have medical device licence number(s) or for Class I devices without authorization identification number(s)

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5} (required)

Anticipated or actual start date of shortage (YYYY-MM-DD) (required)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation (required)

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Report additional device shortages

Device 2

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 3

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 4

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 5

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 6

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 7

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 8

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 9

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Device 10

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in English ^{Footnote 3}

Name of medical device (including any component, accessory or part) that is in shortage, including the model name if applicable, in French ^{Footnote 3}

Other names (for example, trade name), if applicable

Description of the device: Package description (for example, packaging formats, sizes, quantities)

Description of the device: Single-use product

Yes

Class of medical device (I, II, III or IV), if known

III

Unknown

Device identifier(s) (for example, catalogue number, part number, model number or unique device identifier) ^{Footnote 4}

Medical device licence number(s) (for Class II, III and IV)
Note: Please indicate N/A for Class I devices or for devices that have authorization identification number(s).

Authorization identification number(s) for Class I to IV devices authorized by Health Canada for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
Note: Please indicate N/A for devices that have medical device licence number(s) (for Class II, III and IV) or for Class I devices without authorization identification number(s).

Labelled/licensed indications (conditions or reasons for using the device) for the medical device, if known

Reason for shortage

Other - Reason for shortage

Summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur^{Footnote 5}

Anticipated or actual start date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Anticipated or actual start date of shortage

Estimated end date of shortage (YYYY-MM-DD)
Pick a date from a calendar for field: Estimated end date of shortage

Confirmation

By checking this box the reporter acknowledges that an anticipated end date for this shortage has been provided or is confirmed as currently unknown.

Manufacturer's name (required)

Manufacturer's mailing address

Number and name of street (required)

City

Province/Territory/State

Postal code/Zip code

Country (required)

Reporter contact information

Type of reporter

Manufacturer

Importer

Distributor

Other

Specify type of reporter:

First name

Last name

Name of company

Email address (required)

Phone number
Please include country code, if outside North America. Note: Do not use brackets.

Reporter comments ^{Footnote 6}

Footnotes

Footnote 1

A shortage report number will be provided when Health Canada follows up on an initial shortage report. This field only needs to be completed when an 'Update' report is submitted.

Return to footnote 1 referrer

Footnote 2

Select 'Mandatory' if you are a Class I to IV manufacturer, Class I importer or a designated importer, and the device in shortage is found on the List of medical devices.

Select 'Voluntary' if 'Mandatory' does not apply.
Select 'Unknown' if you are unsure.

Return to footnote 2 referrer

Footnote 3

Recommend providing the name as it appears on the label, if available. The medical device, component, accessory or part name may or may not be the same as the device name or licence name.

Return to footnote 3 referrer

Footnote 4

Recommend providing the device identifier (for example, serial number, catalogue number, part number, model number, unique device identifier) as it appears on the label, if available. If necessary, please consult the Medical Devices Active Licence Listing (MDALL), a reference tool for licensed medical devices in Canada. You may also consult other listing tables for devices authorized by Health Canada for exceptional importation and sale under sections 62.27 to 62.32 of the Medical Devices Regulations, including the:

Return to footnote 4 referrer

Footnote 5

Provide information such as:

details on the reason for the manufacturing disruption of the affected medical device
information on a compatible substitute device
details on how long your Canadian inventory will last, given the current and anticipated demand
details on the current Canadian demand for the medical device
details on your total manufacturing capacity for the specified device and how many units of the device your company is shipping to Canada per week/month/year
information (if known) on any compatible substitute devices manufactured by other companies

Return to footnote 5 referrer

Footnote 6

This information may be posted online. Examples of information to include:

description of alternative devices
1-800 support numbers
website for additional information

Return to footnote 6 referrer

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Date modified:: 2024-05-02

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Report a medical device shortage

Privacy notice statement

Shortage information

Report additional device shortages

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