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Guidance Document: Fees for the Review of Medical Device Licence Applications

Date adopted: 1997-05-01
Effective date: 2023-02-22

Document change log

Date Change Location (Section, paragraph) Nature of and/or Reason for change
February 15, 2023 Content updated All Changes to address applications to amend authorizations
April 1, 2020 (posted November 4, 2019) Content was updated. All As of April 1, 2020, new fees along with a revised fee policy will come into force requiring significant changes to the guidance document.
November 20, 2015 Administrative Change S.2.2.2 As of November 9th, 2015, the Accounts Receivable address has changed.

Table of Contents

Introduction

Before a medical device is authorized for sale in Canada, scientific evidence of its safety, effectiveness and quality must be provided to Health Canada. This is required by the Food and Drugs Act (Act) and its regulations.

We assess this evidence to determine if the product’s benefits outweigh the risks. We have charged industry fees for these pre-market regulatory activities since 1998 to recover some of the associated costs.

Objective

This document provides guidance on how Health Canada administers fees for reviewing medical device applications in accordance with the Act. The fees are set out in the Fees in Respect of Drugs and Medical Devices Order and Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act.

Policy statements

Health Canada will charge a fee to:

Scope and application

This guidance applies to manufacturers submitting an application for:

  • a Class II, III and IV medical device licence applications
  • a medical device licence amendment
  • a private label medical device licence
  • a private label medical device licence amendment
  • an amendment to a Class II, III and IV COVID-19 medical device authorization
  • an amendment to a Class II, III or IV COVID-19 private label authorization

Any other type of application is excluded along with medical devices that are:

  • Class I
  • custom-made
  • for special access
  • for investigational testing involving human subjects

Guidance

This section gives detailed information on invoicing and fee payment, mitigation measures, missed performance standards and applicable fees.

Invoicing and fee payment

Medical device licences

Manufacturers wanting to obtain a medical device licence must complete a Medical Devices Application Fee Form (Fee Form) and include it when filing every application. The form outlines the fees and includes sections on fee mitigation measures.

Once we receive the required documents, we will conduct a preliminary examination, verify and adjust the fee if required, and issue an invoice. For most applications, an invoice is issued when the application is accepted into Review 1.

However, we will issue an invoice for the entire fee once we consider an application to be administratively complete for the following applications:

  • new Class II licence
  • Class II Licence amendment
  • new private label licence
  • private label licence amendment

Payment is due 30 days from the date an invoice is issued.

If we reject a Class III or IV medical device licence application during the preliminary examination period, we will issue a notice of rejection and invoice for 10% of the applicable fee. We will issue the invoice at the time of rejection.

If a manufacturer withdraws a Class III or IV medical device licence application:

  • after we have issued a screening deficiency letter, we will acknowledge the withdrawal and invoice for 10% of the applicable fee
  • after we have issued a screening acceptance letter, we will invoice for 100% of the applicable fee

COVID-19 medical device authorizations

Health Canada will waive fees for manufacturers wanting to obtain a COVID-19 medical device authorization as long as the medical device is on the UPHN list.

When a COVID-19 medical device with an authorization is not on the UPHN list, manufacturers must complete a Medical Devices Application Fee Form (Fee Form). They must include it when filing every amendment application when the device is not on the UPHN list. The form outlines the fees and includes sections on fee mitigation measures.

Once we receive the required documents, we will conduct a preliminary examination, verify and adjust the fee if required, and issue an invoice. For most applications, an invoice is issued when the application is accepted into Review 1.

However, we will issue an invoice for the entire fee once we consider an application is administratively complete for a:

  • Class II COVID-19 authorization amendment application
  • COVID-19 private label authorization amendment application

Payment is due 30 days from the date an invoice is issued.

If we reject a Class III or IV COVID-19 medical device authorization amendment application during the preliminary examination period, we will issue a notice of rejection and invoice for 10% of the applicable fee. We will issue the invoice at the time of rejection.

If a manufacturer withdraws a Class III or IV medical device authorization amendment application:

  • after we have issued a screening deficiency letter, we will acknowledge the withdrawal and invoice for 10% of the applicable fee
  • after we have issued a screening acceptance letter, we will invoice for 100% of the applicable fee
Table 1: Withdrawal
Timing of Withdrawal % of Fee Applicable
Class II licence, Class II licence amendment, private label licence, private label licence amendment and Class II or private label COVID-19 authorization amendment applications
After application has been deemed to be administratively complete 100%
Class III or IV licence, Class III or IV licence amendment and Class III or IV COVID-19 authorization amendment applications
Before acceptance into review, assuming a screening deficiency letter has not been issued 0%
Before acceptance into review, but after a screening deficiency letter has been issued 10%
After a Screening acceptance letter has been issued. 100%

For instructions on paying fees, please refer to:

Payments must be in Canadian funds. Cheques must be made payable to the "Receiver General for Canada".

Manufacturers who wish to dispute a fee should contact Health Canada's Food and Drugs Act Liaison Office (FDALO).

Mitigation measures

Fees may be waived or reduced for applications filed by:

  • a small business
  • a publicly funded health care institution
  • any branch or agency of the Government of Canada or of a province or territory
  • by organizations sponsoring medical devices to be sold for the purposes of implementing Canada's Access to Medicines Regime (under section 43.2 of the Medical Device Regulations)

To be considered for mitigation, manufacturers must apply at the time of filing by indicating on the Fee Form the type of mitigation requested. In the case of small businesses, manufacturers must register as a small business and keep their registration information up to date.

Small business

Manufacturers who meet the criteria of a small business will be invoiced at the reduced rate. However, if Health Canada determines that the manufacturer does not qualify as a small business, the full fee will be due. We will issue another invoice for the difference between the full fee payable and the original invoice. For submissions or applications reviewed for free, we will issue an invoice for the full amount.

A small business is any business, including its affiliates, that has:

  • fewer than 100 employees or
  • between $30,000 and $5 million (CAD) in annual gross revenues

Manufacturers who meet this definition are eligible for a:

  • 50% reduction on all medical device licence applications
  • one-time waiver of fees for the first application they file with us

This application is considered the first filed application, even if a manufacturer withdraws that application before we make our final decision or does not receive a positive decision. Health Canada will not review future applications for free.

Manufacturers must indicate that they are requesting small business mitigation on the Fee Form and that this is the first application they have filed with Health Canada. They must formally register as a small business before they submit an application. Manufacturers who have not registered as a small business will be charged the full fee.

Manufacturers must provide the following information when registering:

  • name of company
  • fiscal year-end date
  • annual gross revenue for last completed fiscal year
  • number of full-time or equivalent employees for last completed fiscal year
  • affiliate status
  • breakdown of this information for each affiliated company
  • contact information for all companies listed

Affiliated companies as those that:

  • are controlled by the manufacturer's company, which holds 50% or more of the affiliate's votes or shares
  • control the manufacturer's company, where the affiliate holds 50% or more of the manufacturer's company's votes or shares
  • share a parent company with the manufacturer, where they are controlled by the same company that controls the manufacturer's company

If a company has not yet completed a full fiscal year, they may use estimate or project their annual gross revenue and number of employees. Health Canada will follow up once the manufacturer's fiscal year-end date has passed to verify their small business status.

At any time, we may ask for additional information from the manufacturer to verify their small business status, such as:

  • tax returns
  • financial statements
  • corporate and/or management organization charts
  • records identifying the number of employees for the previous fiscal year
  • other official documents issued or certified by a business registration authority

Publicly funded health care institutions

Health Canada will waive fees for all medical device licence applications filed by publicly funded health care institutions. For example, hospitals filing an application for heart valves will not have to pay a fee.

A publicly funded institution is funded by the Government of Canada or a provincial/territorial government and is:

  • licensed, approved or designated by a province in accordance with the laws of the province/territory to care or treat persons or animals suffering from any form of disease or illness or
  • owned or operated by the Government of Canada or a province/territory and provides health services

Government organizations

Health Canada will waive fees for applications filed by a branch or agency of the Government of Canada or of a province/territory. For example, the Department of National Defence or the Public Health Agency of Canada will not have to pay a fee.

Canada's access to medicines regime

Health Canada will automatically defer fees for manufacturers who also file at the same time an application to sell a medical device under section 43.2 of the Medical Device Regulations. This waiver applies until such time as a medical device licence is issued. We will waive the fees entirely if the manufacturer receives an authorization under section 21.04 of the Patent Act.

Missed performance standards

Health Canada will track the performance for all applications filed individually.

The applicable standard associated with each activity and fee is defined in the Performance Standards for Fees in Respect of Drugs and Medical Devices Order. Most standards reflect the time to complete Review 1, Iteration 1, which is defined as "the period from date of acceptance to date of first decision," not including any review clock pauses. If the review clock has been paused, the duration of the pause will be deducted from the total review time when calculating performance. This means that the days during which the clock is paused will not count when measuring performance.

For more information on pausing the clock, please consult the following guidance document:

If a medical device licence, licence amendment or COVID-19 authorization amendment application is not reviewed within the performance standard, Health Canada will credit manufacturers 25% of the fee paid. We will credit the manufacturer's account within 30 days.

Note: Refunds for a missed performance standard do not apply to applications that:

  • are part of a joint review with a foreign regulatory authority
  • reviewed in parallel with a foreign regulatory authority
  • are for medical device combination products

Health Canada will issue a credit (25% of the applicable fee) with the invoice for the following applications:

  • new Class II licence
  • Class II licence amendment
  • new private label licence
  • private label licence amendment
  • COVID-19 authorization amendment
  • COVID-19 private label authorization amendment

Applicable fees

The applicable fees are laid out in Schedule 1 of the Fees in Respect of Drugs and Medical Devices Order. As of April 1, 2021, fees increase annually to keep up with inflation by an amount equivalent to the Consumer Price Index from the previous year.

Health Canada will publish a notice of intent in Canada Gazette every fall giving the fee amounts that will take effect the following April 1. We will also update the fees for medical devices page.

The fee that is due is based on when an application is filed. This is the date that Health Canada considers the application is administratively complete and meets our standards. The filing date and the date that we receive the application are the same if the application is accepted for preliminary examination with no adjustments required.

However, the filing date will lag behind the date of receipt if we finds the application is administratively incomplete and we need to ask the manufacturer for additional information. For example, if we receive an application on March 15, 2021, but require adjustments and only deem it administratively complete on April 5, 2021, the fee in place on April 5 is the applicable fee.

Note: An application received after 5:00 pm Eastern Standard Time, on a weekend or on a statutory holiday is considered received on the next Health Canada business day.

Please refer to the Fees for examining an application for a medical device licence for:

  • Class II, III, IV and private label medical device licence applications
  • Class II, III, IV and private label licence amendment applications
  • COVID-19 authorization amendments

If a change is made to a fee category during the review of an application, Health Canada will reissue an invoice for the appropriate amount or apply a credit to the manufacturer’s account.

There is no fee for a Class III or IV medical device licence amendment application that does not require a scientific review. For example, we would not charge a fee for a change in the:

  • name of the device
  • medical device identifier
  • name of the manufacturer

For more information on what constitutes a significant change, please consult:

Contact us

Hours of service are Monday to Friday from 8 am to 4 pm (EST) and closed statutory holidays. We will respond to phone calls and emails within 10 business days.

Application and invoice inquiries
Medical Devices Directorate, Bureau of Device Licensing Services
By phone: 613-957-7285
By email: meddevices-instrumentsmed@hc-sc.gc.ca

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

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Regulations and other applicable guidance documents.

Appendix A: Fee remissions

As of April 1, 2020, Health Canada does not remit fees based on individual product sales. The following information applies to manufacturers who have applied for or been granted a fee remission before April 1, 2020, as per the Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act.

Confirmation of the actual gross revenue following the fee verification period

Within 60 days of the end of the fee verification period, the manufacturer must provide sales records for medical devices sold in Canada during the fee verification period. Sales records must be prepared in accordance with generally accepted accounting principles and certified by the person responsible for the manufacturer's financial affairs. Records should include:

  • sales report from an automated accounting system showing the financial period covered and the actual gross revenue in Canadian funds or
  • report from an auditor if no automated accounting system exists

If Health Canada determines at the end of the fee verification period that the amount paid by the manufacturer was less than 2.5% of the actual gross revenue for that product, the manufacturer must pay the lesser of the difference between:

  • 2.5% of the actual gross revenue and the amount originally paid or
  • the fee payable and the amount originally paid

Payment is due within 60 days after the day on which the fee verification period ended.

If Health Canada determines at the end of the fee verification period that the amount paid by the manufacturer was more than 2.5% of the actual gross revenue for that product, we will credit the difference between the amount paid and 2.5% of the actual gross revenue.

If Health Canada determines, based on information available to us, that the sales records provided by the manufacturer were not adequate to determine actual gross revenues, we may require the manufacturer to provide sales records that have been audited by a qualified independent auditor (for example, chartered accountant).

The difference between the amount of the fee paid and the full applicable fee will be immediately payable if the manufacturer does not provide Health Canada with the:

  • sales records within 60 days after the end of the verification period or
  • audited sales records within 60 days of request

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