Tag archives: medical devices

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

By John Greiss, Paul Jorgensen and Kristin Wall on January 19, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

By Sarah Pennington and Kristin Wall on August 9, 2021 Posted in Life sciences and healthcare

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

By Sarah Pennington, John Greiss and Kristin Wall on July 22, 2021 Posted in Life sciences and healthcare

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO … Continue reading

Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

By John Greiss and Kristin Wall on December 3, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to … Continue reading

Health Canada issues Interim Order to address shortages of health products

By John Greiss, Randy Sutton and Brian R. Daley on April 13, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister … Continue reading