Canada

01/10/2023

The Health Canada eSTAR pilot program The FDA and Health Canada are conducting a joint pilot. The pilot will test the use of a single eSTAR submitted to both the FDA and Health Canada. The feasibility of using eSTAR will be determined by the outcome of a pilot with 9 participants. Selected participants will use the non-In Vitro Diagnostic eSTAR, which follows the structure of the IMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC).

11/15/2022

Guidance on clinical evidence requirements for medical devices: Overview "This document provides guidance to manufacturers of Class II, III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices. Guidance is provided on: when clinical data/evidence is required the common methods to generate clinical data how to compare devices appropriately"

11/12/2022

List of Recognized Standards for Medical Devices List of Recognized Standards for Medical Devices

07/11/2022

Application For a New Class IV Medical Device Licence – Updated New class IV medical device licence application form

01/07/2022

Consultation for proposed amendments to the Medical Device Regulations "The proposed amendments for medical devices would: Streamline MDEL application requirements to reflect current practices. Provide the Minister with new and expanded authorities over MDELs, including the ability to issue terms and conditions on an MDEL and partially suspend or cancel an MDEL to mitigate risks to health and safety. Implement ministerial authority to order recalls of medical devices, harmonize the definition of a recall and clarify industry reporting obligations in guidance."

How can RegDesk help?

RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.