Fees for the Review of Medical Device Establishment Licence Applications

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide assistance to Health Canada staff on how mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

This guidance document is an administrative instrument not having force of law; it provides clarification on the applicability of the Fees in Respect of Drugs and Medical Devices Order and how to comply with the associated requirements.

It is important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to administer fees associated with providing regulatory oversight of activities related to drugs and medical devices. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Please note that this guidance document is in effect as of April 1, 2020.

Introduction
- 1.1 Objective
- 1.2 Policy statements
The MDEL fee for new and annual licence review applications
Guidance
Appendix A - Elimination of fee deferrals and remissions

Related guides and help

Related acts and regulations

1. Introduction

As required by the Medical Devices Regulations ("the Regulations") of the Food and Drugs Act, any person who imports into Canada, or sells in Canada, a medical device for human use must obtain a medical device establishment licence (MDEL) with the exception of:

a retailer;
a health care facility;
a manufacturer of Class II, III or IV medical devices who only sells:
- medical devices for which they hold a valid licence, or
- medical devices subject to Parts 2 and 3 of the Regulations;
a manufacturer of a Class I medical device who imports or distributes solely through a licensed establishment;
a person solely selling medical devices subject to Parts 2 and 3 of the Regulations; and
a dispenser.

This document provides guidance on how the fees for the review of an application for a MDEL will be administered, as stipulated in the Fees in Respect of Drugs and Medical Devices Order.

1.1 Objective

This guidance document is intended to assist applicants in fulfilling regulatory requirements related to MDEL fees as per the Food and Drugs Act, its regulations, and the order. In the case of any discrepancies between this document and the Food and Drugs Act (FDA), its regulations, and the order, the latter three take precedence over this document.

1.2 Policy statements

Those submitting MDEL applications will be charged a fee for the examination of the licence application and all compliance and enforcement and supporting activities needed to ensure that the applicant/MDEL holder conforms to all regulatory requirements. The applicable fee is specified in the Fees in Respect of Drugs and Medical Devices Order.

As of April 1, 2020, new fees are in effect. These fees will also increase annually to keep up with inflation. Refer to Section 3.6 Applicable fees for further details.

Should the fee not be paid, Health Canada has the authority to withhold services, approvals or rights and privileges. This may include the cancellation of an establishment licence.

Further, as of April 1, 2020, Health Canada:

Will no longer defer fees for applicants that have not completed their first full financial year ^{Footnote 1}of business nor will it remit, in full or in part, fees for applicants based on gross revenue generated from activities conducted under an establishment licence. However, existing terms and conditions previously granted about fee deferrals and remissions will be honored to those who applied prior to April 1, 2020.
Will offer fee mitigation for small business and Government organizations. Refer to Section 3.4 Fee mitigation and exemptions for further details.
Will credit a portion of the fee in the event that an applicable performance standard is not met. Specifically, applicants' accounts will be credited 25% of the fee paid if the associated performance standard is not met. Refer to Section 3.5 Missed performance standards for further details.

2. The MDEL fee for new and annual licence review applications

The MDEL fee is a flat fee regardless of when in the fiscal year the application is received. The Government of Canada's fiscal year begins on April 1 and ends on March 31 of the subsequent year. The same fee applies to the following types of applications:

an application for a new MDEL^{Footnote 2}
an application for the reinstatement of a suspended MDEL
an application for the Annual Licence Review (ARL) of an MDEL

For applications for a new MDEL and for the reinstatement of a suspended MDEL, the fee covers the examination of the application, as well as the cost of regulatory oversight for the fiscal year in which the application is received.

The application period for the ALR runs from January to March, and the associated ALR fee is charged at the time of the ALR application. For an application for the ALR, the fee covers the examination of the ALR application, as well as the regulatory oversight for the subsequent fiscal year.

For example, for a new MDEL application received on Feb 1, 2021, a new application fee will be charged upon the receipt of the application. If the MDEL is granted before March 31, 2021, since the ALR runs from January to March, the new licence holder will also be required to file an ALR application for the subsequent fiscal year (April 1 2021 - March 31, 2022) and an additional MDEL fee will be payable upon receipt of the ALR application. This will result in two MDEL fees (i.e. one for the new MDEL application and one for the ALR application) being payable in the span of two months.

Guidance

This section provides detailed information on the timing of fee payment, mitigation, exemptions, and credit for missed performance standards.

3.1 Timing of fee payment

Following preliminary examination and upon determination that the application is accepted for further review, Health Canada will issue a notice to the applicant and an invoice for the applicable fee. For information about the MDEL application and licensing process, please refer to Guidance on Medical Device Establishment Licensing (GUI-0016).

Fees may be paid by credit card (Visa, MasterCard, or American Express), cheque, money order, international bank draft, or bank wire. All payments must include a reference to the MDEL licence number or company number to avoid delays or errors. Further instructions for the payment of fees are outlined in the document How to Pay Your Establishment License Fees.

3.2 Late payments

Payment is due upon issuance of the invoice. Interest on overdue accounts begins to accrue 30 days from the date of invoice issuance.

In the event that the applicable fee is not paid in full within 30 days of the invoice date, the application will be placed on cost recovery hold, at which point all work associated with the application will stop. The performance standard for the completion of the review of an MDEL application is 120 calendar days. When an application is placed on cost recovery hold, the countdown against the 120-day service standard will also be halted.

This hold will remain in place until the payment is made. If payment is not received within 45 calendar days from the start date of the cost recovery hold, the application may be rejected and the licence may be subject to cancellation.

Health Canada is committed to working with applicants whose accounts are in arrears, and encourages them to contact us as soon as possible to establish a monthly payment arrangement.

Applicants who have questions regarding their account may contact Accounts Receivable by phone at 1-800-815-0506 or by email hc.ar-cr.sc@canada.ca.

3.3 Overpayments

Any overpayment of fees will automatically be credited to the associated account. To request a refund of a credit balance, a written request must be submitted by email to the Cost Recovery Invoicing Unit at hc.criu-ufrc.sc@canada.ca.

Applicants may also request that their credit balance be applied to their account toward future fees. Applicants wishing to do so must submit a request to the Cost Recovery Invoicing Unit and attach a copy of their most recent statement, indicating the account or client number, as well as the available credit amount.

Applicants wishing to dispute the fee indicated on their invoice may submit a request for reconsideration to the Cost Recovery Invoicing Unit. To ensure the processing of an application is not impeded by a cost recovery hold, it is important that applicants pay their fee on time, even as Health Canada investigates a fee disagreement. Once the review of the fee is complete, any outstanding credits will be issued.

3.4 Fee mitigation and exemptions

Two types of fee mitigation are available:

Fees can be reduced for applications filed by a small business.
Fees can be exempted for applications filed by any branch or agency of the Government of Canada or of a province or territory.

To be considered for fee mitigation, applicants must apply at the time of filing by indicating the type of mitigation requested on the application form.

3.4.1 Small business

Applicants who meet the criteria of a small business will be invoiced at the reduced fee described below. However, should Health Canada subsequently determine that the applicant does not qualify as a small business the full fee is payable. In the event that the reduced fee has already been invoiced and paid, the difference between the full fee and the original invoice will be payable.

A small business is defined ^{Footnote 2} as:

any business, including its affiliates, that has fewer than 100 employees OR
has between $30,000 and $5 million (CAD) in annual gross revenues

Applicants that meet the above definition are eligible for a 25% reduction of the fee payable.

Applicants must be registered as a small business with Health Canada before submitting their application. The registration must be completed via the online Drug and Medical Device Small Business Application.

Additionally, applicants must indicate that they have registered and obtained small business status on the Medical Device Establishment Licence Application: form and instructions (FRM-0292). In the case of an Annual Licence Review (ALR) application, applicants must fill out the Fee Checklist and return it with their application. Indicating small business status on the application or fees checklist does not qualify you as a small business.

Please note that a company's small business status expires a year after registration. If you have previously registered as a small business with Health Canada, and still meet the definition as indicated above, you will need to ensure the status is renewed before submitting your ALR application. If your unique identifier has changed since your previous registration, you will need to register again.

For more information on how to apply or renew for small business status with Health Canada, please visit the Small Business Mitigation webpages. Applicants are also responsible for ensuring their registration information is kept up to date.

Applicants who have not registered as a small business will be charged the full fee. Information should include:

Name of company;
Annual gross revenue for the last completed fiscal year;
Number of full-time or equivalent employees for the last completed fiscal year;
Fiscal year end date;
Affiliate Status;
Breakdown of the above information for each affiliated company; and
Contact information for all companies listed.

Affiliated companies are those that:

Are controlled by the applicant's company whereby the applicant's company holds 50% or more of the affiliate's votes or shares;
Control the applicant's company whereby the affiliate holds 50% or more of the applicant's company's votes or shares; or
Share a parent company with the applicant whereby they are controlled by the same company that controls the applicant's company.

In the event that a company has not yet completed a full fiscal year, it is permissible to use estimates/projections with respect to annual gross revenue and number of employees. In this situation, Health Canada may follow up once the applicant's fiscal year end date has passed to verify the company's small business status.

Note that at any point in time Health Canada may request additional information from the applicant to verify the company's small business status. This may include (but is not limited to):

Records that identify the number of persons employed in the previous fiscal year;
Financial statements;
Tax returns;
Corporate and/or management organization charts; and
Other official documents issued or certified by a business registration authority.

3.4.2 Government organizations

All applications filed by any branch or agency of the Government of Canada or of a province or territory are exempt from fees.

In order to be considered for the Government organization fee exemption, the applicant must indicate it on their Medical Device Establishment Licence Application: Form and Instructions (FRM-0292).

3.5 Missed performance standards

Performance for all applications filed on or after April 1, 2020 will be tracked individually ^{Footnote 4}. The Performance Standards for Fees in Respect of Drugs and Medical Devices Order defines the service standard applicable to each fee associated with drugs and medical devices. For medical device establishment licences, the performance standard of 120 calendar days reflects the time to complete the review of the application. This is defined as the period from the date of receipt of the complete application to the date of approval or rejection of the application, not including any clock pauses or cost recovery holds. Please see the Guidance on Medical Device Establishment Licensing (GUI-0016) for more information regarding the performance standard for MDEL applications and the associated pause the clock policy. Please see the Guidance on Medical Device Establishment Licensing (GUI-0016) for more information regarding the performance standard for MDEL applications and the associated pause the clock policy.

In the event that a regulatory decision is not provided within the established MDEL performance standard of 120 calendar days, applicants will be credited 25% of the fee originally paid. Health Canada will notify the applicant following the processing of the application.

3.6 Applicable fees

The MDEL fee is specified in the Fees in Respect of Drugs and Medical Devices Order. Beginning on April 1, 2020, this fee will increase annually by an amount equivalent to the Consumer Price Index (CPI) from the previous year. An annual adjustment is necessary to ensure that fees continue to keep pace with the impact of inflation on regulatory oversight costs. Each fall, Health Canada will publish a Notice of Intent in the Canada Gazette, setting out the fees to be implemented the following April 1st, and update Funding and Fees accordingly.

3.7 General contact information

Application Inquiries

Medical Device Compliance and Licensing Unit (MDCLU)
Health Canada
By email: hc.mdel.questions.leim.sc@canada.ca

Fee Inquiries

Applicants with fee inquiries and/or those who wish to dispute a fee that is subject to this guidance document should contact:
Cost Recovery Invoicing Unit
Health Canada
200 Eglantine Driveway, Tunney's Pasture
Ottawa, Ontario K1A 0K9
By email: hc.criu-ufrc.sc@canada.ca

Invoice Payment Inquiries

Accounts Receivable
Health Canada
Address Locator: 1918B
18th Floor, Room 1804B, Jeanne-Mance Building
161 Goldenrod Driveway, Tunney's Pasture
Ottawa, ON K1A 0K9
By email: hc.ar-cr.sc@canada.ca
By phone: 613-957-1052 or 1-800-815-0506
By fax: 613-957-3495

4. Appendix A - Elimination of fee deferrals and remissions

Health Canada no longer offers fee deferrals or remissions for applications received on or after April 1 2020. Prior to April 1, 2020, fee deferrals were available for applicants who had not completed their first calendar year of conducting activities under a MDEL, and fee remissions were applicable in instances where gross revenues from product sales under the MDEL met a certain percentage threshold. While Health Canada continues to honour existing fee deferrals and remissions for some applications received prior to April 1, 2020, these mechanisms are no longer available.

Please contact the Cost Recovery Invoicing Unit if your application remains under fee deferral and you have any questions about that status.

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Date modified:: 2022-10-04

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