Canada Proposes 14 New Entries To List Of Recognized Device Standards
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.