Compare
Compare archived captures
This view highlights text differences between two archived captures. It does not interpret meaning or provide guidance.
Descriptive changes only
This comparison highlights text changes between archived captures. It does not interpret the change or provide medical advice. For up-to-date recommendations, always consult the official source website.
Need to cite this comparison? See /cite.
Earlier capture
Fees for the Review of Medical Device Establishment Licence Applications - Canada.ca
Apr 18, 2025
legacy-hc-2025-04-21
ID 211799
Later capture
Fees for the Review of Medical Device Establishment Licence Applications - Canada.ca
Jan 2, 2026
hc-20260101
ID 428915
updated9 sections changed
9 sections changed0 added0 removed+15 / -18 linesChange ratio: 8%
--- +++ @@ -24,7 +24,7 @@ 3.7 General contact information Appendix A - Elimination of fee deferrals and remissions Related guides and help-How to Pay Your Establishment License Fees+How to Pay Health Canada Fees Information on how to register as a Small Business Performance Standards for Fees in Respect of Drugs and Medical Devices Order Guidance on Medical Device Establishment Licensing (GUI-0016)@@ -91,7 +91,7 @@ 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+How to Pay Health Canada 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.@@ -99,17 +99,17 @@ 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+ar-cr@hc-sc.gc.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+criu-ufrc@hc-sc.gc.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 at+criu-ufrc@hc-sc.gc.ca 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+Applicants wishing to dispute the fee indicated on their invoice may submit a request for reconsideration to the Cost Recovery Invoicing Unit at+criu-ufrc@hc-sc.gc.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 Two types of fee mitigation are available:@@ -185,15 +185,13 @@ Medical Device Compliance and Licensing Unit (MDCLU) Health Canada By email:-hc.mdel.questions.leim.sc@canada.ca+mdel.questions.leim@hc-sc.gc.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+criu-ufrc@hc-sc.gc.ca Invoice Payment Inquiries Accounts Receivable Health Canada@@ -202,16 +200,15 @@ 161 Goldenrod Driveway, Tunney's Pasture Ottawa, ON K1A 0K9 By email:-hc.ar-cr.sc@canada.ca+ar-cr@hc-sc.gc.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+Please contact the Cost Recovery Invoicing Unit at+criu-ufrc@hc-sc.gc.ca if your application remains under fee deferral and you have any questions about that status. Page details-Date modified:-2022-10-04+2025-11-17