Health Canada falls short in its regulation of medical devices, finds govt report
This article was originally published in Clinica
Health Canada is failing to meet its obligations to review medical device applications in a timely manner, the Office of the Auditor General (OAG) of Canada has found. In addition, for medical devices already on the market, Health Canada has not determined what level of activities such as inspection and surveillance are needed to protect the health and safety of Canadians, the OAG audit revealed.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.
The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these.