Global Regulatory Updates #8: UK, Nicaragua, and the United States from May 17, 2024

This week's top three global regulatory updates include:
1. UK: The MHRA has launched the AI Airlock project for AI as a medical device. A dedicated webpage will provide project details, key partners, and potential issues. A webinar for innovators and developers is scheduled for June 5, 2024, to discuss the project further.
2. Nicaragua: Ministerial Resolution Number 347/2023 establishes an updated list of fees for services provided by the National Health Regulatory Authority.
3. US: The FDA has released final guidance on remanufacturing medical devices, clarifying when device activities are considered remanufacturing. It includes recommendations for labeling to maintain quality, safety, and effectiveness over the device's lifecycle and outlines regulatory requirements for manufacturers.
Stay tuned for more updates!