Health Canada Reduces Requirements for COVID-19 Device Clinical Trials

Health Canada is streamlining clinical trials for devices, other than Class I devices, relating to COVID-19.

The agency issued an interim order and guidance for drugs and devices that support applications to sell or import a COVID-19 medical device for clinical trial purposes.

The interim order defines the terms and content of the application and notes that the minister may suspend device authorization if conditions in the order aren’t met.

The policy is intended to prioritize the review of clinical trial applications designed to investigate the diagnosis, treatment, mitigation or prevention of COVID-19.

The interim order provides an expedited authorization pathway for COVID-19 devices, and it eases administration requirements for trials that involve devices already on the market.

Read the guidance here: www.fdanews.com/06-05-20-Guidance.pdf.