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New Brazil INMETRO Ordinance Eases Inspection and Documentation Requirements
In Brazil, a new ordinance was published by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), providing updated conformity assessment standards and documentation requirements.
US FDA Unveils Next Steps for Regulating Artificial Intelligence-Based Medical Software
US regulators explain evolving approach to oversight of SaMD based on artificial intelligence and machine learning. Learn more about FDA regulation of medical software and healthcare cybersecurity at Emergo by UL.
Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions
New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater powers for regulatory authorities relating to post-market surveillance and risk management.