Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) (effective December 14, 2026)

Please only email any completed MDEL application forms, amendments or notifications to the MDEL application email account at: mdel.application.leim@hc-sc.gc.ca. We are unable to process any mailed in application forms.

When to use this form

If you sell or import any class of medical devices in Canada, you must apply for and maintain a Medical Device Establishment Licence (MDEL), unless you meet exemption(s) in section 44 of the Medical Devices Regulations. You must use this form to apply for an MDEL.

Use this application form to:

• apply for an MDEL
• apply for an MDEL after a cancellation
• submit changes to your existing MDEL (for example, amendment or section 48 notification)
• cancel your MDEL
• reinstate your MDEL after a suspension

How to complete FRM-0292

How much of this form you need to complete depends on the type of application you are submitting. For example, when you first apply for an MDEL, you must complete the entire form. For Amendments, when you make a change in one section you must review remaining sections to make any corresponding changes. For an MDEL cancellation, you must complete only section 1 and Appendix A: Cancellation of Medical Device Establishment Licence. See the application checklist to find out which sections apply to your specific situation.

To complete this form properly, follow these 7 steps:

• Step 1: Learn about MDELs
• Step 2: Determine if your product is a medical device
• Step 3: Determine if your activities require an MDEL
• Step 4: Register as a small business (if applicable)
• Step 5: Complete the application form
• Step 6: Review the MDEL fees
• Step 7: Submit your application form

Step 1: Learn about MDELs

Before filling out this form, you should carefully review Guidance on medical device establishment licensing (GUI-0016).

Step 2: Determine if your product is a medical device

You must ensure that the devices listed in your application are classified as medical devices. You must also determine the correct class of each medical device (Class I, II, III or IV).

Any fees you pay for the review of this application will not be refunded if you list products that are not medical devices or choose the wrong class.

To correctly indicate your product's classification, you may:

• Contact the manufacturer identified on the product label to ask for verification of the class of the device, and confirm that the medical device is licensed or authorized in Canada.
• Search the active Medical Devices Active Licence Listing (MDALL) to see if the product is a licensed Class II, III or IV medical device.
  • Confirmation of device licence can be made by matching the product label to the company information, device name and device identifier found in the MDALL database.
  • Regardless of whether similar medical devices are listed as Class II, III or IV medical devices, if your medical device is not listed in the MDALL database, then it is not licensed and cannot be imported or sold in Canada.
• Read Guidance on the risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) and Guidance for the risk-based classification system for in vitro diagnostic devices (IVDDs).
• Make a classification support request by contacting the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca

Step 3: Determine if your activities require an MDEL

For more detailed guidance on who needs an MDEL, see Table 1: MDEL requirement based on activity type of Guidance on medical device establishment licensing (GUI-0016).

Step 4: Register as a small business (if applicable)

Companies looking to apply for the small business fee mitigation must formally register as a small business on Health Canada's website. You must register and receive small business status from the Drug and Medical Device Small Business Application before submitting your MDEL application.

• To register as a small business, you must have a unique identifier.
• To locate or obtain a unique identifier, please see small business mitigation for drugs and medical devices.

For more information on fees and small business mitigation, including a link to the Drug and Medical Device Small Business Application, please see funding and fees.

If your company is not registered as a small business when you file your MDEL application, you will be charged the full fee and will not be considered for the small business fee mitigation.

Step 5: Complete the application form

Section 1: Application type

Indicate the reason for your application.

• New: applying for your first MDEL or applying for a new MDEL after a cancellation of a previous MDEL.
• Notification: you must submit a notification to Health Canada within 15 calendar days of:
  • a change in the name or address of your establishment
  • a change in the information of the establishment representative associated with your MDEL application including name, title and contact information
• Amendment: you must inform Health Canada of any other changes affecting the information on your MDEL. For example, if the list of manufacturers, activities or class of devices change, you must submit the information through your annual licence review (ALR) application.
• You can proceed with the changes before your licence is updated.
• If you wish to submit those changes before the next ALR, you can do so through an amendment application using FRM-0292, only from April 1 to mid-November.
• Amendment to terms and conditions: request a change to a term or condition previously imposed on an MDEL under section 48.1 of the MDR, in a cover letter submitted with the form.
• Cancellation: request to cancel your MDEL (see Appendix A: Cancellation of Medical Device Establishment Licence of the form).
• Reinstatement: request reinstatement of your licence after a suspension by Health Canada.

If your establishment has had any current or previous MDELs, please include the current or previous MDEL numbers in this section.

If your establishment has a company ID, please include your company ID in this section. It is a 6-digit number assigned by Health Canada.

If there is any other name under which you previously conducted a licensable activity, please include in this section. Include names associated with a merger, if applicable. You do not need to include names associated with acquisitions.

Section 2: Applicant information

Fill in your establishment information:

• Establishment name is the legal name of the person.
• Person (as defined in section 2 of the Food and Drugs Act and section 1 of the Medical Devices Regulations): person means an individual or an organization as defined in section 2 of the Criminal Code. It includes a partnership and an association.
• Operating, trade or partnership name(s) are any other company names under the applicant's ownership (same legal entity as the applicant), as applicable.
• Small businesses: certify that you have received confirmation from Health Canada that the small business registration or renewal for your company has been processed and that you hold valid small business status with Health Canada at the time of submitting the application. You may qualify for a reduction in fees if you meet the definition of "small business" as defined in section 1 of the Fees in Respect of Drugs and Medical Devices Order. See the Guidance document: Fees for the Review of Medical Device Establishment Licence Applications for more details.
• Government organizations: indicate if you are a government organization. All applications filed by any branch or agency of the Government of Canada or of a province or territory are exempt from fees. Consult section 3 of the Fees in Respect of Drugs and Medical Devices Order for more details.
• Publicly funded health care institution: indicate if you meet the definition for a publicly funded health care institution. All applications filed by publicly funded health care institutions are exempt from fees. Consult section 3 of the Fees in Respect of Drugs and Medical Devices Order for more details.

2.1 Establishment address

• Establishment licence address is the main physical address. This is the address that will appear on your licence. A.P.O. box will not be accepted as an establishment licence address.
• Business Number (BN) for an establishment in Canada is a 9-digit number that is unique to your business and is used when dealing with federal, provincial or local governments.

2.2 Contact person

• Contact person for the establishment licence is the person Health Canada will contact concerning the MDEL application. For example, Health Canada will send the annual licence review package to the contact person for the establishment licence.
  Information required concerning your application is the name, title, email and telephone number of the representative of your establishment Health Canada is to contact.
• Email is the main means by which Health Canada communicates with the contact person.

2.3 Mailing address - 2.4 Billing address

• Mailing address: include your mailing address if different from licence address under section 2.1 (establishment address) of the application form and include your mailing address if different from licence address.
• Billing address: include your billing address and billing contact information if different from address in 2.1 (establishment address) and 2.3 (mailing address).

As per section 48 of the Medical Devices Regulations, an establishment must notify Health Canada if there is a change in the name or address of the establishment or if there is a change in the name, title or contact information of the establishment representative associated with the application.

This must be submitted within 15 calendar days of the change being made by notifying the Medical Devices Establishment Licence Unit at mdel.application.leim@hc-sc.gc.ca.

Section 3: Activities

Check the box for each activity and class of medical device that applies to your operations. For further information on activities, see Table 1: MDEL requirement based on activity type and Table 2: Licence requirements and exemptions of Guidance on medical device establishment licensing (GUI-0016).

Only an establishment located in Canada can be an importer. The activity of importation includes distribution. For example, if an establishment imports medical devices and subsequently distributes the devices, under the 'Activity' section, they should select 'Importer' for those device classes.

Only importation and distribution are licensable activities under an MDEL. Manufacturing is not licensable under an MDEL, however, the MDEL permits a manufacturer to import or distribute their own Class I manufactured medical device.

Section 4: Sites

You must list at least 1 building (including the establishment address as applicable) in section 4. This is where the documented procedures referred to in paragraph 45(j) of the Medical Devices Regulations are implemented.

If the site listed is not the same legal entity, then it is the responsibility of the licence holder to ensure that site(s) listed in section 4 of their MDEL application has the applicable procedures in place and that inspectors are able to verify compliance without any impediment.

You may list a building under section 4 (site), including a warehouse, as long as the following conditions are satisfied:

• A P.O. box is not considered an acceptable site address
• A site must be in the same country as the establishment.
  For example, if the main address for the MDEL (the establishment licence address) is located in Canada, then only sites within Canada can be listed in section 4. If the establishment licence address is located in the U.S, then only sites within the U.S can be listed in section 4

If you are amending the list of sites for an existing MDEL, select the status 'Inactive' to indicate any sites you wish to remove (no longer use).

Indicate the procedures in place at each site you list. Health Canada inspectors will verify that you have these procedures in place during an inspection.

Indicate the names of the manufacturers of the medical devices that you import or distribute in section 5. Do not list this information in section 4.

Section 5: Manufacturers of the devices that are being imported or distributed, and your suppliers

List all manufacturers and suppliers of the medical devices you import or distribute (sell). This section must not be left blank.

• Manufacturer: The name of the manufacturer is on the label of each device.
• Supplier: A supplier is any person, other than the manufacturer, who distributes (sells) a medical device to an MDEL holder for the purpose of import or sale in Canada.

Please read this information carefully:

• If you are a Class I manufacturer who imports or distributes your own devices: Include your name and address in this section as the manufacturer.
• If you are an importer, a distributor or both of Class I medical devices: Provide the names and full addresses of all the manufacturers and suppliers of the Class I medical devices you will be importing or distributing (as per the activities indicated in section 3 of the application form).
• If you are an importer, a distributor or both of Class II, III or IV devices: You must search the Medical Devices Active Licences Listing (MDALL) database for the manufacturers of all the medical device licences of Class II, III or IV medical devices you import or distribute.
  • Visit the MDALL and search for each manufacturer of your Class II, III or IV medical devices. You can search by device identifier (found on the label), product or company name or company ID.
  • Confirm that the manufacturer is licensed or authorized for all the devices you will be importing or distributing (selling).
  • On your application form FRM-0292, enter the name and address listed in MDALL for each manufacturer.
    This address should match the address found on the product label.
  • Enter the 6-digit company identification (ID) number, as listed in MDALL.
  • Indicate the manufacturer's class(es) of devices you will be importing or distributing (selling).

At least one active manufacturer is required for each class of medical device you indicated in Section 3.

If you are amending the list of manufacturers or suppliers for an existing MDEL, select the status 'Inactive' to indicate any manufacturer or supplier you wish to remove (no longer use).

Add more pages or email mdel.questions.leim@hc-sc.gc.ca to request the FRM-0292 Section 4-5 Addendum (Excel) if needed to make multiple entries.

For Class II, III or IV devices, an establishment shall only sell licensed devices (as per section 26 of the Medical Devices Regulations), unless authorized under the Medical Devices Regulations.

Section 6: Signature

A completed section 6 is required for all application types except cancellation requests.

A senior official from your establishment must carefully read, sign and date this section. The application must be signed before it can be reviewed by Health Canada.

Senior official: The senior official listed on an MDEL application is a person who has direct knowledge of documented procedures. They confirm this by signing in section 6 on the MDEL application to acknowledge that all the information in the application is accurate and all required procedures are in place.

Manufacturers of Class I to IV medical devices and importers of Class I medical devices have an obligation to report medical device shortages and discontinuations that will lead to a shortage to Health Canada. This is in accordance with section 62.23 of the Medical Devices Regulations.

For more information, refer to the Guide to reporting medical device shortages and discontinuations (GUI-0137).

The name of the senior official associated with an MDEL is published in Health Canada's medical devices establishment licence listing along with other posted information about establishments.

Conducting activities contrary to any existing terms and conditions (under section 48.1 of the Medical Devices Regulations) is subject to compliance and enforcement actions.

Appendix A: Cancellation of MDEL

If you choose to cancel your licence for any reason, complete sections 1-1 and 1-2 and Appendix A: Cancellation of MDEL of FRM-0292 when all activities under this MDEL have ceased. Once cancelled, we will notify you by email and the MDEL will be inactive.

Only the contact person or senior official for the MDEL may submit a cancellation request to Health Canada.

Health Canada may inspect an establishment that had its MDEL cancelled to verify that all licensable activities have ceased.

Step 6: Review the MDEL fees

Once Health Canada screens the application and determines that the application is accepted for further review, we will notify you, via email, and include an invoice for the applicable fees.

You must pay a fee for the review or examination of:

• a new application
• a reinstatement application
• an annual licence review application

There are no fees for notifications, amendments or to cancel your licence.

If you have not paid the fees that are due for an MDEL application, Health Canada has the authority to withhold services, approvals, rights or privileges.

Should Health Canada use this authority to stop the review of an application, the time where services are withheld does not count towards Health Canada's 120 calendar day service standard.

For more information about fees related to MDELs, see:

• Fees for the Review of Medical Device Establishment Licence Applications and
• How to Pay Health Canada Fees

Step 7: Submit your application

1. Send only 1 application form.

   Submitting duplicate applications may delay the processing of your application.

2. Submit your application by email, include all sections and Excel addendum if applicable.

   • Email: mdel.application.leim@hc-sc.gc.ca

3. Always keep copies of the application and all information sent to Health Canada. Always keep records demonstrating that your application and information has been received by Health Canada before April 1 of each year for the annual licence review (ALR).

   • Save the email sent or carbon copy (cc) yourself.
   • During a regulatory inspection, inspectors may request a copy of the MDEL application submitted to Health Canada for review and copies of documented procedures in place at each site. Establishments must have this information available.
   • If you have made a change to your licence or it is a new application, review the MDEL licence you receive from Health Canada and ensure it is accurate based on the information you submitted. Contact the Medical Devices Establishment Licence Unit at mdel.application.leim@hc-sc.gc.ca if there are any issues.

     An existing licence continues to be valid as long as Health Canada receives a completed ALR application before April 1 of each year.

We will notify you by email that your new application has been accepted for further review or examination. An invoice for any applicable fees will follow soon after.

Service performance standards

The performance standard to issue a decision is 120 calendar days from the day a complete application is received. This performance standard applies to:

• new application
• annual licence review (ALR) application

For more information on the performance standard, see the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order.

All MDEL applications will be screened for completeness against the following criteria:

• application file is not corrupt
• application file is not password-protected
  • we do not accept password-protected PDF documents
• all sections of the application form are complete and signed
• presence of all indicated documents and emails
• verification or confirmation of changes requested

Once the application is deemed complete, a company identification is identified or assigned and the 120-day clock is started.