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Medical Device

FDA Issues New Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during COVID-19 Emergency

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European Medicines Agency Issued Electronic Certificates for Medicines

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Medical Device Change Control Process

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European Medicines Agency – Explanatory Note on Implementation of ICH Q12 Guideline

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Danish Medicines Agency: Newly Improved Reporting Requirement to Strengthen the Surveillance of Medical Devices

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USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

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