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eu council/egypt/esubmitter/siemens healthineers 483/cfda sees increase adverse event reports
Home » Regulatory Affiars

Regulatory Affiars

Canada
Canada Offers Guidance on Classifying Products at the Drug-Device Interface

Russia
Russia Proposes Ban on Municipal Procurement of Imported Devices

United Kingdom
MHRA Seeks Input on Approach to EU Animal Tissue, eLabeling Regulations

European Union
EU Internal Trade Rapporteur Further Refines Notion of ‘Single-Use Device’

United States
Industry to U.S. FDA Draft Guidance on ISO-10993 Could Delay Reviews
U.S. FDA Considers Prequalifying Device Development Tools
U.S. Conflict Minerals Case Delayed As Compliance Deadline Inches Closer

India
India Considering Separate Regulatory Authority for Biotechnology Products

Saudi
Saudi FDA Sets Criteria for Bundling Device Marketing Authorizations

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