The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]
VICTORIA BC, September 25, 2020 (BUSINESSWIRE) – StarFish Medical, Canada’s largest medical device design, development, and manufacturing service provider, announced today that the Winnipeg Ventilator 2.0 has received a Health Canada COVID-19 Medical Device Authorization under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 made by […]
It’s always great to spend time with regulators to understand their point of view on the regulations and guidances they provide to us. It is also helpful to hear about the changes going on at Health Canada to gain insight into their roadmap for the future.
In early 2019 Health Canada released more specifics of their Action Plan on Medical Devices. The Action Plan is intended to reinforce Health Canada’s commitment to ensuring that Canadians have access to safe and effective medical devices based upon the most up to date information. It has a three-prong strategy involving: i) improve regulatory rigor […]
Health Canada has announced, as part of the Regulatory Transparency and Openness initiative, online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review. This means more information about medical devices will be available to consumers, and more importantly, health care providers.