Guidance on medical device establishment licensing (GUI-0016): How to apply for an MDEL

On this page

• Types of MDEL applications
• Applying for an MDEL
• Submitting your application for an annual licence review

Types of MDEL applications

There are 5 types of medical device establishment licence (MDEL) applications. These are described in Table 3.

Table 3: MDEL application types and their respective requirements

Type	Requirements
1. New application	Required for new applicants. Also required if you are resuming the sale of medical devices after Health Canada cancelled your previous licence or you had cancelled it as the licence holder. If your MDEL was cancelled because the licence was suspended for a period of more than 12 months, your establishment will need to submit documentation with the application to demonstrate that the situation(s) that gave rise to the suspension has been corrected. The documentation can include an adequate corrective and preventive action (CAPA) or a corrective action plan (CAP). To verify that the corrections have been implemented, Health Canada will inspect your establishment before we render a decision on your licence.
2. Notification	If you have an MDEL, you must notify us within 15 calendar days if you make the following changes: name and address of the establishment name, title, email and/or phone number of the representative of the establishment who is the contact for any information concerning the application
3. Cancellation	Required if you no longer conduct licensable activities under an MDEL. Health Canada has the authority to cancel your licence if: you fail to submit an annual licence review application by April 1 of each calendar year or your MDEL has been suspended for a period of more than 12 months
4. Amendment	If you require changes to information on your MDEL that are not captured under a notification. Examples include changing the activities or classes of medical devices, sites and/or list of manufacturers or suppliers.
5. Reinstatement	Required if you want to resume selling or importing medical devices after Health Canada has suspended your MDEL. For your MDEL to be reinstated, your establishment will need to submit documentation with the application to demonstrate that the situation(s) that gave rise to the suspension has been corrected. The documentation can include an adequate corrective and preventive action (CAPA) or a corrective action plan (CAP). To verify the corrections, Health Canada will inspect your establishment before we render a decision about your licence.

Applying for an MDEL

Please ensure your application is complete before submitting to Health Canada.

The Minister of Health has new fee-setting authorities that grant the ability to set and adjust fees to better reflect actual costs. Fees will be charged according to the Fees in Respect of Drugs and Medical Devices Order.

Some establishments may be eligible for a small business fee reduction of 25%. To apply for this reduction, you must hold valid small business status (via the Health Canada Drugs and Medical Device Small Business Application) at the time of application.

For more information on how to apply for small business status or how to renew your existing status:

• Funding and fees

Fees can be requested to be waived for applications filed by any branch or agency of the Government of Canada or of a province or territory. To be considered for fee exemption, applicants must apply at the time of application, using the application form.

Application process

Diagram 1 highlights the application process.

Diagram 1. Outlines the MDEL application process

Diagram 1 - Text description

This flowchart is divided into two sections:

• the left section is entitled, "Application Process"
• the right section is entitled, "Health Canada".

The left section indicates the steps of the application process. The right section describes the tasks of Health Canada.

Step 1 is titled "Application received". In this step, Health Canada received the MDEL application.

Step 2 is titled "Screen application". Health Canada screens the application for completeness. You have 2 opportunities to address deficiencies in your application, after which you will be screened out.

Step 3 is titled "Invoice". If the application is complete, Health Canada will send you an invoice.

Step 4 is titled "Payment of fee". Health Canada will begin to review your application after payment is received. You have 30 calendar days to pay your invoice fees. Applications will be rejected for non-payment.

Step 5 is titled "Application review". In this step, Health Canada will assess and evaluate activities and content of your application.

Step 6 is titled "Decision". Health Canada will issue a licence decision.

How to apply

Step 1:

Even if you sell or import only 1 medical device, complete:

• Medical device establishment licence application form (FRM-0292).

Note: The form contains detailed instructions.

Include the following in your application:

• the name and address of your establishment
• any other names under which you previously conducted a licensable activity, including names associated with a merger, if applicable. You do not need to include names associated with acquisitions
• the name, title, email, and phone number of the representative for your establishment
• statement on whether you are the importer or distributor for medical devices (or both) and whether you manufacture Class I medical devices which you distribute
• the names and addresses of the manufacturers for each medical device you will import or distribute

Note: The manufacturer is the establishment listed on the medical device label. It may not be the same establishment that you buy the medical device from. Check your labels before adding the manufacturer to your application.

Also include in your application the following:

• the class (Class I, II, III or IV) of each medical device you will import or distribute
• an attestation signed by a senior official for the documented procedures that must be in place depending on the activities conducted at the establishment

The attestation you need to have signed depends on whether you are an importer, distributor, or manufacturer.

Importers

For importers of all classes of medical devices, the attestation should state that your establishment has written operating procedures for:

• handling complaints and recalls
• maintaining distribution records
• reporting incidents

For importers of Class II, III or IV medical devices, the attestation should also state that your establishment has written operating procedures for:

• submitting information for any serious risk of injury to human health
• properly handling, storing, delivering, installing, correcting, and servicing medical devices (where applicable)

Distributors

For distributors of all classes of medical devices, the attestation should state that your establishment has written operating procedures for:

• handling complaints and recalls
• maintaining distribution records

For distributors of Class II, III or IV medical devices, the attestation should also state that your establishment has written operating procedures for:

• properly handling, storing, delivering, installing, correcting, and servicing medical devices (where applicable)

Manufacturers

For manufacturers of Class I medical devices that import or distribute their own medical devices, the attestation should state that your establishment has written operating procedures for:

• handling complaints and recalls
• maintaining distribution records

Your application must also include the site addresses of each building where the documented procedures you attested to are in place. This is outlined in paragraphs 45(g) through 45(j) of the MDR. Note the following:

• If applicable, you must indicate the site(s), including a warehouse, in section 4 of FRM-0292 where the documented procedures are in place.
• If the site listed is not the same legal entity, you as the licence holder must ensure that the site(s) listed in section 4 of the application have the applicable procedures in place and that inspectors are able to verify compliance without impediment.
  • Manufacturers of the medical devices that you import or distribute will not be accepted as a site.
  • A site must be in the same country as the establishment.
  • A post office box is not an acceptable site address.

Step 2:

Email the completed application form to mdel.application.leim@hc-sc.gc.ca.

Do not submit duplicate applications as this may slow down the processing.

If you email your application but have other items that cannot be transmitted through email, please contact mdel.application.leim@hc-sc.gc.ca for further guidance.

When to expect a reply

Health Canada will issue a decision within 120 calendar days from the day we receive a complete application for:

• a new application
• an annual licence review (ALR) application

This is our performance standard.

If a regulatory decision is not provided within the established performance standard, applicants will be credited 25% of the fee originally paid. We will notify the applicant after we process the application.

For more information on the performance standard, consult:

• Performance standards for the Fees in Respect of Drugs and Medical Devices Order

After you submit your application

After we receive your application, we will screen it to make sure it is complete. We verify completeness using the following criteria:

• application file is not corrupt
• application file is not password-protected (we do not accept password-protected PDF documents)
• all relevant sections of the application form are complete and signed
• all indicated documents and emails are present
• any changes requested have been made

If the application is complete, we will notify you by email that your application has been accepted for further examination/review. An invoice for the applicable fees will follow soon after.

Submit payment only after you receive an invoice from us.

Payment is due within 30 calendar days from the date of the invoice. Interest on overdue accounts begins to accrue 30 days from this date.

We are committed to working with applicants whose accounts are in arrears. Please contact us as soon as possible to work out a monthly payment arrangement.

If the applicable fee is not paid in full within 30 days of the invoice date, the application will be placed on cost recovery hold. All work associated with the application will stop. The countdown against the 120-day service standard also stops. We also have the authority to withhold services, approvals, rights and/or privileges.

The cost-recovery regime ensures that payment is received before we process the application. If we use this authority to stop the review of an application, the period of time when services are withheld does not count toward our 120-day service standard.

For more information about MDEL fees, consult:

• Fees for the review of medical device establishment licence applications
• How to pay your establishment licence fees

Pause-the-clock policy

We use a "clock" to measure performance against the 120-calendar day service standard.

• The clock starts on the date when we receive your complete application.

If the applicant fails to meet the application requirements listed in the Food and Drugs Act or Medical Devices Regulations, we will issue a deficiency notice. A deficiency is when an application does not meet regulatory requirements, or the intent/scope of the application is not clear. The applicant is given an opportunity to submit the missing or incomplete information in order to avoid receiving a negative decision within 30 business days.

The clock is paused for up to 30 business days at a time.

• When we receive a response to a deficiency notice, the clock resumes.

If we do not receive a response after the first deficiency notice or if the response is inadequate, we will issue a second notice and give another 30 business days to respond.

If we do not receive a response after the second notice or if the response is inadequate, we will reject the new application and cancel your MDEL if it is an ALR application.

Checking your application status

You may request a status update by sending an email to mdel.questions.leim@hc-sc.gc.ca if:

• you have not received a notice that your application has been accepted for further examination within 30 calendar days from the date we received it
• it has been 120 calendar days since you submitted your application and we have yet to notify you of our decision

Licensing decisions

If your application meets all the requirements of section 45 of the MDR, Health Canada will issue an MDEL.

We may refuse to issue you an MDEL under the following circumstances:

• if your MDEL application contains false or misleading statements
• if the Minister or delegated authority has reasonable grounds to believe that issuing you an MDEL would constitute a risk to the health or safety of patients, users, or other persons

If either is the case, we will notify you in writing of the reasons for refusal and you will be given an opportunity to be heard. This is outlined in section 47 of the MDR.

Submitting your Annual Licence Review (ALR) application

Under the MDR, all active MDEL holders must submit an application for annual licence review (ALR) before April 1 of each year. The ALR is to ensure that licence holders are continuing to comply with regulatory requirements and maintain up-to-date information.

You must submit this application and pay the fee upon invoicing even if there are no changes to your licence.

Diagram 2 outlines the timeline for the annual licence review.

Diagram 2. Annual licence review timeline

Diagram 2 - Text description

This flowchart is divided into two sections:

• the upper section is a monthly timeline
• the lower section indicates the requirements at each time point noted in the flowchart.

In December, Health Canada emails an annual licence review (ALR) application package to all active MDEL holders.

January to February is the recommended submission period of an ALR application from MDEL holders to Health Canada.

April 1 is the due date for your ALR application to be sent to Health Canada.

In April to July, the processing of ALR applications is completed by Health Canada.

As a courtesy, Health Canada sends an ALR application package to all MDEL holders at the end of each calendar year. However, it is your responsibility to ensure that we receive a complete ALR application before April 1 of each year.

If you do not receive your ALR package by mid-January, contact us to receive your package and ensure that your application contact information is up-to-date.

After you submit an ALR application:

• We will review your application within 120 calendar days from the day we receive it.
• Your licence will continue to be valid as long as you submit your ALR application before April 1 of each year and pay the fee within 30 calendar days from the invoice date.
• You will receive 2 confirmations by email: one that your application has been entered in our system and another when we have completed our review.
• We will contact you if the application is incomplete or we have concerns.
• You will only receive a revised copy of your MDEL if, as a result of the ALR process, there is a change that affects the content of your MDEL.
  • For example, if the name or address of the establishment, activities or medical devices classes change, you will receive a revised copy of your MDEL (refer to the section "After you submit your application" for information on fees and invoicing).