Fees for the Review of Medical Device Establishment Licence Applications

This guidance is posted for information purposes only and will come into effect as of April 1, 2020. Please refer to current guidance on establishment licences for cost recovery requirements that apply until March 31, 2020.

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.

Table of Contents

  1. Introduction
  2. The MDEL fee for new and annual licence review applications
  3. Guidance
  4. Appendix A - Current 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:

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 order. In the case of any discrepancies between this document and the Food and Drugs Act (FDA), its regulations, and 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, including 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 will be in effect. These fees will also increase annually to keep up with inflation. Refer to Section 3.6 Applicable fees for further details.

Should fees 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:

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

The MDEL fee is a flat fee. The same fee applies to the examination of the following types of applications:

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 in order 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. This hold will remain in place until the required payment is made. If payment is not received within 30 days following the cost recovery hold, the application may be rejected. In the case of annual licence review, 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 to pay (or partially pay) future fees in advance. Applicants wishing to do so must submit a request 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 by email at hc.criu-ufrc.sc@canada.ca. 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

Fees can be requested to be waived or reduced for applications filed:

To be considered for mitigation, applicants must apply at the time of filing by indicating the type of mitigation requested on the application form. In the case of small businesses, applicants will be required to register as a small business and ensure that their registration information is kept up to date (see below for more information).

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 amount had already been invoiced and paid, the difference between the full fee and the original invoice is payable.

A small business is defined Footnote 3 as:

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

Applicants must indicate that they are requesting small business mitigation on the Medical Device Establishment Licence Application: Form and Instructions (FRM-0292). Applicants must visit Funding and Fees and formally register as a small business by providing the information below. Applicants who have not registered as a small business will be charged the full fee.

Affiliated companies are those that:

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 will 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):

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 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.

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 accordingly 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, 2021, 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
By fax: 613-957-4147

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
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

Appendix A - Current fee deferrals and remissions

Effective April 1, 2020, Health Canada no longer offers deferrals for applicants that have not completed their first calendar year of conducting activities under a MDEL, or remissions associated to actual gross revenue. The following information is specific to applicants who have applied for, or been granted a fee deferral or remission, prior to April 1, 2020, as per Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act.

1.1 Deferred payments

For an applicant who has not completed its first full calendar year of conducting activities under any MDEL, the payment of the applicable MDEL fee is deferred until the end of that first full calendar year. "Calendar year" means a period of 12 consecutive months commencing on January 1. At the end of the deferral period the applicant must pay all of the applicable fees.

If it is determined, on the basis of any information available to Health Canada, that an applicant does not qualify for payment deferral, all applicable fees are immediately payable with interest.

1.2 Fee remission

If an applicant's total payable fee is greater than 1% of the actual gross revenue generated by activities conducted under a MDEL during the previous calendar year, fee remission will be reviewed and considered. The amount remitted will equal the difference between the total applicable fees and the amount of 1% of the applicant's actual gross revenue.

If an applicant wishes to apply for fee remission, it must make this request by submitting a Medical Device Establishment Licence Calculation Chart, and a Certified Statement of Revenue signed, by the individual responsible for the applicant's financial affairs, that sets out the actual gross revenue along with the application. The statement can be a signed copy of the applicant's general ledger or signed copy of sales logs from the general ledger.

1.2.1 Confirmation of the actual gross revenue

If it is determined, based on any information available to Health Canada, that the information provided by the applicant in support of a request for fee remission was not adequate to determine their actual gross revenues, Health Canada may require the applicant to provide sales records that have been audited by a qualified independent auditor (i.e., a chartered accountant). The audited records are to be used for the purpose of determining the fee payable or the amount of the remission.

If the applicant does not submit audited sales records within 60 days after Health Canada makes an official request for such records, remission will be automatically denied. The full MDEL fee will be payable with interest.

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