Frequently Asked Questions - Medical Device Establishment Licensing and Fees

Table of Contents

General Questions

1. What is a medical device?

The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices. Medical devices are categorized into four classes based on the level of risk associated with their use. Class I devices present the lowest potential risk (e.g. thermometers) and Class IV devices present the greatest potential risk (e.g. pacemakers).

2. What is required to sell a medical device in Canada?

There are two types of licences issued by Health Canada for medical devices sold in Canada. The first is a licence for the actual device itself and the second is a licence for the establishment (company). The device licence is called a Medical Device Licence (MDL) while the establishment licence is called a Medical Device Establishment Licence (MDEL).

An MDL is issued to the manufacturer of class II, III, or IV devices by the Medical Devices Bureau (MDB) of the Therapeutics Products Directorate based on review of scientific evidence for quality, safety and efficacy. For information on medical device licences, please contact the MDB:

• E-mail: device_licensing@hc-sc.gc.ca
• Telephone: (613) 957-7285
• Fax: (613) 957-6345

3. What is a Medical Device Establishment Licence (MDEL)?

A Medical Device Establishment Licence is separate from a Medical Device Licence and is issued for the activities of importing and selling medical devices for human use in Canada. An MDEL is issued by the Inspectorate based on an establishment certifying that they meet certain requirements and are then inspected for compliance.

4. Who requires an MDEL?

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence.

5. Who is exempt from having an MDEL?

The following are exempt from holding an MDEL:

• a retailer;
• a healthcare facility;
• a manufacturer of Class II, III or IV medical devices that only sells:
  • medical devices for which they hold a valid licence, or
  • medical devices subject to Parts 2 and 3 of the Medical Devices Regulations
• a manufacturer of a Class I medical device that imports or distributes solely through a licenced establishment;
• a person solely selling medical devices subject to Parts 2 and 3 of the Regulations; and
• a dispenser.

6. What should I know before filing an application for an MDEL?

Since there are no provisions for refund of fees, once an application has been submitted to Health Canada for review, it is your responsibility to make sure to confirm the following before filing an application:

• ascertain the classification of your device in Canada;
• determine the appropriate licence fee payable to Health Canada;
• complete and file a Medical Device Establishment Licence (MDEL) application; and
• provide accurate and true information on application forms.

7. How should I confirm classification before applying for an establishment licence?

Guidance is provided in the following documents located on the Therapeutic Products Directorate website:

• Draft Guidance for the risk based classification system
• Draft Guidance for the risk based classification system of in vitro diagnostic devices
• Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices

You can contact the Medical Devices Bureau for classification:

• E-mail: device_licensing@hc-sc.gc.ca
• Telephone: (613) 957-7285
• Fax: (613) 957-6345

Applying for an MDEL

8. How do I apply for an MDEL?

Complete the Medical Device Establishment License Application.

Submit the application form to:
ELapplicationLE@hc-sc.gc.ca

If you submit your application to Health Canada by email or fax but have other documents, such as fees, that need to be sent by mail, please include a copy of the email/fax as the cover page of the mailed information.

Fax: (613) 957-4147

Establishment Licensing, Billing and Invoicing Unit
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Graham Spry Building - Second Floor
Address Locator 2002C
Ottawa, ON K1A 0K9

Please do not submit duplicate applications.

9. Is there a fee for obtaining an MDEL?

Yes, there is a flat fee for the review of a new MDEL application. The fee for an application submitted during the fiscal year starting April 1, 2013 ending March 31, 2014 is $7,491.

According to Fees in Respect of Drugs and Medical Devices Regulations every fee set out in the Regulations is to be increased annually by 2%, rounded up to the nearest dollar, beginning on April 1, 2012.

10. What is the completion time for the review of an MDEL application?

The performance standard for the review of an MDEL application is 120 calendar days, on average, from the day it is received by Health Canada. A decision whether or not to issue an MDEL may be made earlier or later than that and is based on the individual application.

11. Will I receive an acknowledgement following my application?

Yes, you will receive an acknowledgement when we receive your application.

12. How do I check the status of my application?

The service standard for processing MDEL applications is 120 calendar days, on average, from the day it is received. We will promptly respond to licensing progress requests if your inquiry identifies that:

• You have not received an Acknowledgment Notice for an application that was submitted to our office more than two (2) weeks ago.
  
  OR
• It has been 120 calendar days since the application was submitted and a decision regarding the application has not been issued.

For both situations, you may send a status request to MDEL_questions_LEPIM@hc-sc.gc.ca.

Note that we will contact applicants by email and/or fax during the licensing process should we have questions or require additional information.

13. Are there Health Canada guidance documents regarding MDELs?

Yes. The Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees is available on Health Canada's Website.

14. What is required for the signed attestations on the MDEL application form?

The attestations page of the application contains four statements (see below) with respect to documented procedures that must be in place depending on the activities conducted at the establishment. The applicable procedures are to be identified by a check mark in the appropriate box. The Chief Executive Officer or other senior officer of the establishment must then sign the application in order to make the attestations and to acknowledge the statements.

15. Why are signed attestations required on an MDEL application form?

The attestation from a senior representative of a company that certain procedures required under the Medical Devices Regulations (MDR) are in place assures Health Canada that establishments are aware of their responsibilities under the MDR. It provides a level of assurance that medical devices sold or imported into Canada meet the safety requirements set out in the MDR, and that procedures are in place to protect the public should a problem with a device be identified.

16. If I only sell one medical device a year, do I still need to hold an MDEL?

Yes. Any person who imports or sells a medical device for human use in Canada requires an MDEL. The requirement to hold an establishment licence does not depend on the quantity sold per year.

17. I bring medical devices into Canada for further sale. What activities should I list on my application: importer and/or distributor?

As a Canadian company responsible for bringing medical devices into Canada you would be considered an importer. If you are also selling medical devices received from a manufacturer or supplier in Canada, you would also be distributor. If you are a company located outside of Canada but selling medical devices in Canada, you would be considered a distributor.

18. What do I list as a site?

At a minimum, your licence address (the address that appears on your licence), must be listed as a site. Any other building that the same procedures in place must also be listed as a site.

19. Where do I find the company IDs? Is it the same as my registered business number?

The company ID is not your business number. It is a six (6) digit number assigned by Health Canada. For companies that import/distribute for manufacturers of class II, III and IV medical devices you can find the company ID on www.mdall.ca. This website lists all manufacturers of class II, III and IV that currently hold an active medical device licence (MDALL).

20. What if my application is incomplete?

During the review of an MDEL application, Health Canada will contact the applicant if it is determined that any information necessary for the issuance of a licence is missing. The applicant will be provided an opportunity to submit the missing information. Health Canada's primary means of contact is by e-mail; therefore, it is important that the establishment maintain up-to-date contact information, including an e-mail address, for information requests.

Failure to respond to an information request may result in the rejection of the application, which may lead to the cancellation of the licence.

Amendments

21. When must I submit an amendment to my MDEL? How do I submit these changes?

As per section 48 of the MDR, an establishment must inform 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 company representative associated with the application.

Establishments must inform Health Canada within 15 days of making this change. Establishments may inform Health Canada of this change by e-mail, by submitting a cover letter describing the changes, or by submitting a revised application form. These may be submitted as described in Question 8.

22. If my company intends to add another activity or class of device to our business line, must Health Canada be informed?

Except as described in section 48, any other amendment/change must only be identified at the next application, such as annual review. No application is required prior to beginning new activities or adding different classes of medical devices.

23. Is there a fee for an amendment?

No. There is no fee for amending an existing, valid MDEL.

Annual Review

24. What is an Annual Review?

Under the revised Medical Devices Regulations (MDR), MDEL holders must submit an application for Annual Review before April 1 of each year. The purpose of the annual review is to ensure continued compliance with regulatory requirements and to maintain up-to-date information.

25. Is there a difference between the previous Licence Renewal and the current Annual Review?

Yes, there is a difference. The term Renewal is no longer used because as of April 1, 2011, establishment licences no longer expire. An existing licence continues to be valid as long as a completed Annual Review application is received by Health Canada before April 01.

26. Is there a fee for Annual Review?

Yes, the fee for the review of an annual review application submitted between April 1, 2013 and March 31, 2014 is $7,491. The fee is due with the application.

According to  Fees in Respect of Drugs and Medical Devices Regulations, every fee set out in the Regulations is to be increased annually by 2%, rounded up to the nearest dollar.

Some establishments may be eligible for a reduced fee. Please consult the questions on fee remission.

27. If there are no changes to my licence, do I still have to submit an application for Annual Review?

Yes, an Annual Review application, along with the applicable fees, must be submitted before April 1 of each year even if there are no changes.

28. What is the deadline for submitting the Annual Review applications?

Annual review applications, along with the applicable fees, must be submitted before April 1 of each year.

29. What if I do not submit my annual review application before April 1?

If an annual review application is not received, the MDEL is cancelled on April 1. Please see question 34.

30. May I submit my Annual Review by email?

Yes. Please see question 8.

31. What is the completion time for an Annual Review?

The performance standard for the review of an MDEL application is 120 calendar days, on average, from the day it is received by Health Canada.

32. Will my current licence be valid during the Annual Review?

Yes, your licence remains valid as long as you submit the application for Annual Review before April 1 each year. Please note that any applicable fee must be submitted at the time of application.

33. How will I know when my Annual Review is completed?

You will receive an updated licence once the review process is complete.

You will be contacted if the application is incomplete or if any concerns are raised that may affect the issuance of the licence. Please see question 18.

Other Questions

34. What do I do if my licence is cancelled?

Establishments that do not hold a valid MDEL, including those whose licences were cancelled as they did not submit an annual review application before April 1, are not permitted to perform licensable activities.

In order to resume licensable activities, you will need to submit a completed application form and submit it with the appropriate fees. If you are eligible for fee remission, do not forget to include a certified statement of revenue with your application. If the application is found to be complete, a new MDEL number will be issued and you may resume licensable activities.

35. What do I do if my licence is suspended?

Establishments that have had their MDEL suspended are not permitted to perform licensable activities. A decision to suspend an MDEL is taken to protect the health and safety of Canadians if and when there is a risk identified. The proposal to suspend and the opportunity to be heard process is based on the steps outlined in the Regulations.

36. Do I have to pay for a reinstated licence?

Yes. If your licence was suspended or cancelled, you must submit payment with your application to reinstate the licence. The applicable fee is the same as the fee for a new MDEL or annual review application.

37. Important dates and deadlines for MDELs and fees

Example: If first MDEL was issued February 1^st, 2013

Year	Annual Review	Fee Due	Fee Remission Request
Table 1 footnotes This table applies to any new establishment who is issued their first licence any time during 2013. For new establishments, the fee is deferred until the end of their first full calendar year of activities under the licence. In this example, the first full calendar year of activities is 2014. Health Canada will contact establishments who have completed their first calendar year of activities advising them of the requirements to pay their fee and submit a fee remission request, if applicable.
2013	Not required	Fee Deferred until Dec. 31, 2014	Fee Deferred until Dec. 31, 2014
2014	Before April 1st, 2013	Fee Deferred until Dec. 31, 2014	Fee Deferred until Dec. 31, 2014
2015	Before April 1st , 2015	At time of application	With application
On-going	Before April 1st each year	At time of application	With application

38. Who should I contact if I have further questions?

For more information about MDELs, please contact MDEL_questions_LEPIM@hc-sc.gc.ca. For questions about fees, please contact ELIU_UFLE@hc-sc.gc.ca.

General Questions - Fees

39. Why does the Government of Canada charge for an MDEL?

The fees associated with an MDEL cover a portion of the cost of Health Canada's regulatory programs for medical devices. This includes work related to inspections, compliance verifications, establishment licensing, compliance monitoring, monitoring device recalls, and importations.

40. What is the fee for a new MDEL or the Annual Review of an existing MDEL?

There is a flat fee for the review of a new or annual review application. For applications submitted between April 1, 2013 and March 31, 2014 the fee is $7,491.

According to  Fees in Respect of Drugs and Medical Devices Regulations, every fee set out in the Regulations is to be increased annually by 2%, rounded up to the nearest dollar, beginning on April 1, 2012.

41. Is anyone exempted from fees?

No. The MDEL fee applies to all MDELs.

42. I am a new applicant. Do I need to pay when applying?

A 'new applicant' is one that has not completed its first full calendar year of conducting activities under an MDEL. A company whose licence was cancelled and who was issued a new number is not considered a new company.

As a new applicant, your application fee is deferred until the end of your first full calendar year of activities under the licence. Health Canada will contact new applicants at the end of their deferral period to advise them of the fee requirements and provide and opportunity to apply for fee remission.

Example:
If an applicant who has never previously held an MDEL is issued their licence on any day in 2013, the payment of the fee is deferred until the final business day of December 2014.

43. I am applying for an Annual Review; when / where do I pay my fees?

Payment and fee remission request (if applicable) is due with the Annual Review application. Please see question 8 on how to submit an application.

44. Is there a fee for an amendment to an MDEL?

There is no fee to amend an MDEL.

45. Do I have to pay for a reinstated licence?

Yes. If your licence was suspended or cancelled, you must submit payment with your application to reinstate the licence. The applicable fee is the same as the fee for a new MDEL or annual review application.

46. If I am issued a new licence part way through the year, do I still have to pay the full fee?

Yes. You will have to pay the full fee as the fee is not prorated.

47. Will I be reimbursed if I withdraw my application for an MDEL or if my licence is cancelled?

No, the fee remains payable and will not be reimbursed. The fee is for the review of an application. Therefore, if an establishment chooses to withdraw its application or if the licence is cancelled, Health Canada will not credit or refund any of the fees paid by the establishment, as these fees cover expenses already incurred.

Note: it is your responsibility to determine that the device indicated on your application is considered a medical device in Canada and to obtain information on the class of the device. Please see question 7 for instructions on confirming classification.

If it is determined upon review that a product is not in fact a medical device, Health Canada will not refund the MDEL fee.

48. Can I be exempted from paying an invoice?

If fees are applicable, you cannot be exempted from payment of the fees. Health Canada will not credit or refund any of the fees paid by the establishment. Please see question 47.

Fee Remission

49. What is a fee remission?

The fee for the review of an application for an MDEL can be reduced to 1% of an establishment's annual gross revenue for activities conducted under the licence. A complete fee remission request must be submitted at the same time as submitting an MDEL application to Health Canada.

50. Am I eligible for a fee remission?

You are eligible for a fee remission if the fee payable is greater than 1% of actual gross revenue generated from activities conducted under an MDEL during the previous calendar year. For instance, if the MDEL fee is $7,491, you are eligible for fee remission when you submit your annual review application if your revenue for sales under the MDEL was less than $749,100 in the previous calendar year.

51. What sales should I use when calculating my annual gross revenue for activities conducted under an MDEL?

The annual gross revenue is the amount earned by an establishment during a calendar year from sales in Canada of medical devices for which an MDEL was required. Sales in Canada include the exports of medical devices, except those for which section 37 of the Food and Drugs Act has been invoked. Revenue from sales at retail should not be included as these activities are exempt from the MDEL requirements.

52. Do I need to apply for a fee remission every year?

Yes, a fee remission request must be submitted every year as part of the Annual Review application.

53. How do I apply for a fee remission?

To request a fee remission, your application must include the following:

• A complete application form
• A Certified Statement of Revenue signed by the delegated signing authority responsible for your financial affairs that sets out the annual gross revenue generated from the activities conducted under your MDEL.
• Payment for the reduced amount

To facilitate the review process, we encourage you to submit a calculation chart with your application.

54. I am a new company. How do I apply for a fee remission?

A 'new company' is one that has not completed its first full calendar year of conducting activities under an MDEL. A company whose licence was cancelled and who was issued a new number is not considered a new company.

If you are a new company applying for an MDEL, your fee is deferred until the end of your first full calendar year of activities under the licence. Health Canada will contact applicants who have completed their first calendar year of activities advising them of the requirements to pay their fee and submit a fee remission request, if applicable. Applicants will have 30 days to respond and submit the appropriate payment along with a fee remission request, if applicable.

To facilitate the review process, we encourage you to submit a calculation chart with your application.

55. What is a Certified Statement of Revenue?

A Certified Statement of Revenue is a statement signed by the individual responsible for your company's financial affairs that sets out the annual gross revenue from the sales conducted under the MDEL.

Health Canada does not provide a Certified Statement of Revenue form or template. As examples, the Certified Statement can be a signed letter on company letterhead, a signed copy of the applicant's general ledger or a signed copy of sales logs from the general ledger. The statement must clearly demonstrate the actual gross revenue from the Canadian sales of medical devices for the last completed calendar year. For example, if the Certified Statement of Revenue is submitted to Health Canada in February 2014, it must show the revenue from sales between January 1, 2013 and December 31, 2013.

56. How will I know if my fee remission request is approved?

Only applicants who do not qualify for a fee deferral or fee remission will be notified as to why their fee remission is denied and the resulting fee that is due.

57. What is the Calculation Chart and how do I use it?

The Calculation Chart is a tool that Health Canada uses to help determine the total fee and the potential fee remission for an MDEL. The chart and instructions can be found online. To facilitate the review process, we encourage you to submit a calculation chart with your application.

58. Can Health Canada ask for an audited statement?

Yes, Health Canada can ask for an audited statement. If the information supplied in support of a fee remission request is deemed inadequate to determine your actual gross revenue, Health Canada may require the applicant to provide sales records audited by a qualified independent auditor. The audited records will be used to determine the fee payable and you will be required to bear the cost of the independent audit.

Payment of Fees

59. What methods are available for the payment of fees?

For further instruction on the payment of fees, please see our guide on How to Pay Fees.

Fees may be paid by credit card (Visa, MasterCard, or American Express), cheques, money orders, international bank drafts, or bank wires.

Payment of fees by credit card (Visa, Mastercard or American Express) or in Canadian funds (by cheque or money order) is strongly advised, as payment in non-Canadian funds may result in delays in crediting your account. This may cause a risk of under payment due to fluctuating exchange rates, interest charges and balances owing. Payments made by wire may result in similar processing delays.

1. Cheques, money orders or international bank drafts should be made payable to the "Receiver General for Canada". Cheques drawn on non-Canadian banks MUST be issued in coordination with a referenced Canadian bank (that is, referenced on cheque), otherwise they are not accepted.
2. Credit card payments (Visa, Mastercard or American Express) are accepted provided the following information is provided on the form overleaf:
   • Cardholder's full card number;
   • Cardholder's name, address and telephone number;
   • Expiry date.
3. Wire payments of fees paid in advance of the service will be accepted only when wired in Canadian funds to:
   • Bank Name: Scotiabank
     Toronto Business Service Centre
     40 King Street West, Toronto, Ontario, Canada, M5H 1H1
   • SWIFT: NOSCCATT
     Bank Number: 002
     Transit Number: 47696
     Beneficiary Name: HEALTH CANADA - CFOB
     Beneficiary Account Number: 476961242210
     Description Field: 022-22879 *Also include your company name and product name, as well as your invoice number and customer number, if applicable.
   • Include the following information with the submission / application:
     • date the funds were wired;
     • name of the bank the funds were sent from;
     • the amount of money wired (Canadian $);
     • a copy of the transaction receipt from your bank.

You are responsible to ensure all service charges, including fees charged by your bank or any intermediary banks, are covered by your payment. Health Canada is not responsible for any fees charged during the transfer process. Failure to pay the full amount outstanding will result in a balance owing on your account. Any payments sent in non-Canadian funds will be rejected. For further information on wire payment, contact Accounts Receivable at 1-800-815-0506, (613) 957-1052 or via email at AR-CR@hc-sc.gc.ca. If problems occur with the transaction, please contact the Scotiabank at (416) 866-6430.

60. Do I have to pay interest on an overdue account?

Yes, you have to pay interest on an overdue account. If full payment is not received within 30 days of the invoice date, interest will accrue. You will receive monthly invoices until the debt is cleared.

Interest will not be waived once it is accrued. The fee plus any accrued interest will have to be paid.

61. What happens if my account is in arrears? Will it be sent to a collection agency?

If Health Canada is unable to recover the outstanding balance on your account, the account may be turned over to a collection agency.

62. If my account is in arrears, what are my options to pay off my debt?

Health Canada is committed to working with applicants whose accounts are in arrears, and encourages them to contact Accounts Receivable at 1-800-815-0506, (613) 957-1052, or via email at AR-CR@hc-sc.gc.ca as soon as possible to work out a monthly payment arrangement.

63. What is a payment arrangement?

A payment arrangement is an agreement between the applicant and Health Canada to recover the amount due to the Receiver General for Canada for an MDEL. Repayment schedules allow fixed monthly payments by the client, repaying the debt in the shortest period of time possible. The establishment of a repayment schedule will mean that the account is not sent to a collection agency, provided the client repays according to the terms and conditions established with the agreement.

64. What is the interest rate on the money I owe to Health Canada for a licence in arrears?

Currently, the interest rate is equal to the Bank of Canada rate +3%. It is up to the client to verify interest rates, if and when applicable.

65. What can I do if I don't agree with the calculation of my fees?

If you do not agree with the calculation of your fees, you may file a request to reconsider. Please submit your request to:

• Email: ELIU_UFLE@hc-sc.gc.ca
  
  OR
• Establishment Licensing, Billing and Invoicing Unit
  Health Products and Food Branch Inspectorate
  250 Lanark Avenue
  Graham Spry Building - 2^nd Floor
  Address Locator 2002C
  Ottawa, ON K1A 0K9
  
  OR
• Fax: 613-957-4147

66. What happens in the case of an overpayment?

Overpayment of fees will be automatically credited to account. A written request is required for refund of a credit balance. In addition, you may request that we apply your credit balance to payment / partial payment of advance fees. In this case, please attach to the submission / application a copy of the most recent statement indicating the account or client number / amount of available credit.

For further instruction on how to submit payment, see our guide on How to Pay Fees.

67. Important dates and deadlines for MDELs and fees

Example: If first MDEL was issued February 1^st, 2013

Year	Annual Review	Fee Due	Fee Remission Request
Table 2 footnotes This table applies to any new establishment who is issued their first licence any time during 2013. For new establishments, the fee is deferred until the end of their first full calendar year of activities under the licence. In this example, the first full calendar year of activities is 2014. Health Canada will contact establishments who have completed their first calendar year of activities advising them of the requirements to pay their fee and submit a fee remission request, if applicable.
2013	Not required	Fee Deferred until Dec. 31, 2014	Fee Deferred until Dec. 31, 2014
2014	Before April 1st, 2014	Fee Deferred until Dec. 31, 2014	Fee Deferred until Dec. 31, 2014
2015	Before April 1st , 2015	At time of application	With application
On-going	Before April 1st each year	At time of application	With application

68. Who should I contact if I have further questions?

For more information about MDELs, please contact MDEL_questions_LEPIM@hc-sc.gc.ca. For questions about fees, please contact ELIU_UFLE@hc-sc.gc.ca.