Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292)

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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

The following table shows the icon used in this document, and the way it is intended to be used.

Important: Key or cautionary information you want people to know.

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. However, 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 seven steps:

  • Step 1: Learn about MDEL's
  • 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: 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 classify your product(s):

  1. Contact the manufacturer identified on the product label to ask for verification of the class, and confirm that the medical device is licensed in Canada.
  2. You can look up classification of a medical device in Health Canada's Guidance for Industry – Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices. This is a guidance document and may not include your device.
  3. 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 device, if your medical device is not listed in the MDALL database, then it is not licensed and cannot be imported or sold in Canada.

    Do not list manufacturers or devices classes for medical devices that are not found in the MDALL. This can lead to compliance issues on future inspections of your establishment conducted by Health Canada inspectors.

    Class I (low risk) medical devices do not require a medical device licence (MDL) and will not be found on the MDALL website.

  4. 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).
  5. Make a classification request by contacting the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.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 Licencing (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.

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 isn’t 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 telephone number

      See section 48 of the Medical Devices Regulations for more details.
  • Amendment: submit any changes to your existing MDEL as soon as they happen (for example, list of manufacturers, change in activity or class of device).
    • Mid-December to March 31 –submit your changes as part of your Annual Licence Review (ALR) application.
    • April 1 to mid-December –submit your changes using this form.
  • Cancel: request to cancel your MDEL (see Appendix A: Cancellation of Medical Device Establishment Licence of the form).
  • Reinstatement: reinstate 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 six (6) digit number assigned by Health Canada.

Section 2 – Applicant information

Fill in your establishment information:

2.1 Establishment address
  • Establishment licence address is the main physical address. This is the address that will appear on your licence. P.O. Box will not be accepted as an establishment licence address.
  • Business Number (BN) is a nine-digit number that is unique to your business and that 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 is the name, title and telephone number of the representative of your establishment to contact for your application.
  • 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, 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 telephone number 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 Compliance and Establishment Licensing Unit at hc.MDEL.application.leim.sc@canada.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).

Section 4 – Sites

Site(s) – any additional building that is used by the MDEL holder (establishment) for keeping the procedures attested to in paragraphs 45(g) to (i) of the Medical Devices Regulations.

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 be 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:

  • P.O. Box is not considered an acceptable site address.
  • You must indicate at least one site in section 4 where the documented procedures are stored.

    If there are more than one site where the documented procedures are in place, you must indicate all these sites in section 4 and the specific documented procedure(s) at each site listed.
  • 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, or if the establishment licence address is located in the USA, then only sites within the USA can be listed in section 4.

You must indicate the procedure(s) in place at each site you list. Health Canada inspectors will verify that you have these procedures in place during an inspection.

If you are an importer or distributor, then indicate the manufacturer in section 5 below. Do not list manufacturer of the medical devices that you import or distribute in section 4.

Section 5 – Manufacturer or supplier information

List all manufacturer(s) or supplier(s) of the medical devices you import or distribute (sell).

  • Manufacturer – The name of the manufacturer is on the label of each product.
  • 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 the information below carefully:

  • If you are a Class I manufacturer: Include your name and address in this section.
  • If you are an importer and/or a distributor of Class I medical devices: Provide the names and full addresses of all the manufacturers 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 and/or a distributor 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 for all the classes of devices you will be importing and/or distributing (selling).
    • On your application form, enter the name and address listed in MDALL for each manufacturer.

      Note: 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 and/or distributing (selling).
    • Add more pages, if needed.

For Class II, III, or IV devices, an establishment shall only sell licensed devices (as per section 26 of the Medical Devices Regulations), unless the medical devices are subject to Part 2 or 3 of the Medical Devices Regulations.

Section 6 – Attestations

A senior official from your establishment must complete the attestations provided under paragraphs 45(g), (h) and (i) of the Medical Devices Regulations, as applicable, based on the activities conducted by your establishment (see section 3 of this application form).

Senior official – The senior official listed on a MDEL application is the person who has direct knowledge of the procedures in place, as confirmed by signing attestations in section 7 on the MDEL application.

Read each statement and check or initial each applicable attestation statement.

False attestations on this application could lead to:

  • a refusal of your application under subsection 47(1,) of the Medical Devices Regulations, or
  • a suspension of your licence under paragraph 49(1)(b) of the Medical Devices Regulations

Health Canada's Compliance and Enforcement Policy for Health Products (POL-0001) and Guidance on Medical Device Compliance and Enforcement (GUI-0073) state that the primary responsibility of a regulated party is to understand its obligations under the Food and Drugs Act and its Medical Devices Regulations, and to comply with these requirements. Regulated parties who fail to comply will be subject to compliance and enforcement actions.

Health Canada will inspect your establishment to verify your attestation in section 6 and your establishment's compliance with the Medical Devices Regulations. More information on inspections conducted by Health Canada is found in How Health Canada Inspects Medical Device Establishments (GUI-0064).

Section 7 – Signatures

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

Senior official – The senior official listed on a MDEL application is the person who has direct knowledge of the procedures in place, as confirmed by signing attestations in section 7 on the MDEL application.

Appendix A – Cancellation of MDEL

If you choose to cancel your licence for any reason, complete section 1 and Appendix A - Cancellation of MDEL on the MDEL application when all activities under this MDEL have ceased. Once cancelled, you will be notified 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: 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/examination of:

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

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

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

Should Health Canada use this authority to stop the review of an application, the period of 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 the Guidance document – Fees for the Review of Medical Device Establishment Licence Applications and How to Pay Your Establishment License Fees.

Step 7: Submit your application

  1. Send only one application form.

    Submission of duplicate applications may delay the processing of your application.

  2. Choose email or mail.
    • Email: hc.MDEL.application.leim.sc@canada.ca (preferred)
    • Mail: Medical Devices Compliance and Establishment Licensing Unit
      Regulatory Operations and Enforcement Branch, Health Canada
      Jeanne Mance Building – Address Locator 1903C
      200 Eglantine Driveway – 3rd Floor
      Ottawa, ON K1A 0K9
  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 ALR.
    • Save the email sent or carbon copy (cc) yourself.
    • During a regulatory inspection, inspectors will request a copy of the MDEL application submitted to Health Canada for review and copies of documented procedures attested to in the application. 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 Compliance and Establishment Licensing Unit at hc.MDEL.application.leim.sc@canada.ca if there are any issues.
  4. Keep all relevant shipping or mailing records.
    • To submit hard copy information (such as fees related to an application previously sent by email, print the email that was already sent and enclose it with the hard copy documents.

      An existing licence continues to be valid as long as a completed ALR application is received by Health Canada before April 1 of each year. You will only receive a hard copy if there are changes to the MDEL, for example, added sites and/or licensable activities or the attestations have changed.

When will you hear from us?

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

  • 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/ emails
  • verification/confirmation of changes requested

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

Pause-the-clock policy

Health Canada uses a "Clock" to measure performance against the 120 calendar day service standard.

  • The clock starts on the date when Health Canada receives your complete application.
  • In cases where the application requirements listed in the Food and drugs Act or its Medical Devices Regulations are not met, a deficiency notice is issued to the applicant and the clock is paused.
  • When Health Canada has received a response to a deficiency notice, the clock will be resumed.

Health Canada will contact you by email during the licensing process if we have questions or need additional information.

A deficiency is when an application cannot be processed by Health Canada because it does not meet regulatory requirements or the intent/scope of the application is unclear. The applicant is provided an opportunity to submit the missing or incomplete information in order to avoid receiving a negative decision within 30 business days.

In such circumstances, the application clock would be paused for up to 30 business days at a time. If no response is received after the first deficiency notice or if the response that is received is inadequate, a second notice will be issued providing an additional 30 business days to respond.

If no response is received after the second notice is issued to address the same deficiency, or if the received response is inadequate, the application will be rejected.

Appendix – Acronyms and References

Acronyms

ALR
Annual Licence Review
MDALL
Medical Devices Active Licence Listing
MDEL
Medical Device Establishment Licence
MDL
Medical Device Licence

References

Laws

Guidance

Online Listing

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