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).
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"
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."
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