Medical Device Archives - Focal Point https://focalpointresearch.net/category/medical-device/ Scientific, Regulatory and New Product Consultants Thu, 02 Apr 2026 20:06:39 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://focalpointresearch.net/wp-content/uploads/2021/11/cropped-focal_point_chart_03-32x32.jpg Medical Device Archives - Focal Point https://focalpointresearch.net/category/medical-device/ 32 32 126679100 Health Canada modernizes Medical Device Submission Requirements https://focalpointresearch.net/health-canada-updates/health-canada-modernizes-medical-device-submission-requirements/ Thu, 02 Apr 2026 20:06:37 +0000 https://focalpointresearch.net/?p=5808 Health Canada has introduced several key regulatory updates in 2026 that significantly change how medical device applications are prepared and submitted. A major update is the new Guidance on Managing Applications for Medical Device Licenses (effective February 2, 2026), which replaces the previous version and introduces stricter timelines and enhanced screening procedures. In addition, as […]

The post Health Canada modernizes Medical Device Submission Requirements appeared first on Focal Point.

]]> Health Canada has introduced several key regulatory updates in 2026 that significantly change how medical device applications are prepared and submitted. A major update is the new Guidance on Managing Applications for Medical Device Licenses (effective February 2, 2026), which replaces the previous version and introduces stricter timelines and enhanced screening procedures.

In addition, as of April 01, 2026, all Class II, III and IV medical device applications and amendments must be submitted electronically through the Regulatory Enrolment Process via the Common Electronic Submissions Gateway. Email submissions will no longer be accepted.

Health Canada has also implemented a new Terms and Conditions framework for device licenses, strengthening post-market oversight and adopted the International Medical Device Regulators Forum Table of Contents format to align with global standards. These changes aim to streamline submissions and improve regulatory efficiency.

If you need additional information or guidance on navigating these new processes, please reach out to us.

The post Health Canada modernizes Medical Device Submission Requirements appeared first on Focal Point.

]]> 5808 The DEL and MDEL renewal season is here!  https://focalpointresearch.net/canadian-regulatory/the-del-and-mdel-renewal-season-is-here/ Mon, 18 Mar 2024 19:31:29 +0000 https://focalpointresearch.net/?p=5357 All DEL and MDEL holders, please be reminded that the deadline to submit your renewal applications this year is Mar. 31, 2024, in order to ensure compliance with regulatory requirements and continue with licensable activities. This process involves an annual fee payable at the time of licence renewal. Renewal applications outline that the information submitted […]

The post The DEL and MDEL renewal season is here!  appeared first on Focal Point.

]]> All DEL and MDEL holders, please be reminded that the deadline to submit your renewal applications this year is Mar. 31, 2024, in order to ensure compliance with regulatory requirements and continue with licensable activities.

This process involves an annual fee payable at the time of licence renewal. Renewal applications outline that the information submitted with the licence application and any subsequent amendments has not changed. Health Canada has already sent out renewal reminders to stakeholders. If you have not received an email with your renewal package, please do reach out to Health Canada to obtain this.

If you would like assistance compiling and submitting your renewal application, please contact us. 

The post The DEL and MDEL renewal season is here!  appeared first on Focal Point.

]]> 5357