Regulatory Insights & Updates

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Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework
Medical Devices and IVDsOctober 23, 2025

Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

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Detailed process on Bolivia registration and timelines
Medical Devices and IVDsOctober 23, 2025

Detailed process on Bolivia registration and timelines

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License Transfer for Medical Device to new Local AR – New Zealand
Medical Devices and IVDsOctober 23, 2025

License Transfer for Medical Device to new Local AR – New Zealand

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Safety Reporting on Clinical investigation
Medical Devices and IVDsOctober 23, 2025

Safety Reporting on Clinical investigation

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EU MDR – Language Requirements 
Medical Devices and IVDsOctober 23, 2025

EU MDR – Language Requirements 

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EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers
Medical Devices and IVDsOctober 23, 2025

EU Publishes New Regulation to Address In Vitro Diagnostic Device (IVDD) Shortages: Key Updates and Recommendations for Manufacturers

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