Regulatory Updates
Aug 31, 2026•2 min read
PMDA Provides Guidance and Consultation Services for SaMD Approval
PMDA outlines resources, consultations, and guidelines to support developers of software as a medical device (SaMD) in Japan.
Regulatory Updates
Aug 25, 2026•1 min read
MHRA Issues Guidance for Reporting Adverse Incidents with Diabetes Management Equipment
The MHRA urges healthcare professionals to support new guidance on reporting suspected adverse incidents related to insulin pumps and CGM devices.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA releases seven English translations on pediatric drug development guidance
The PMDA published seven English translations of notifications and administrative notices related to pediatric drug development, including a revision of the planning guidance for adult drug programs.
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Regulatory Updates
Aug 23, 2026•1 min read
PMDA Issues Early Guidance on Clinical Evaluation of Factor VIII & IX for Pediatric Hemophilia
The Pharmaceuticals and Medical Devices Agency released early considerations for evaluating blood coagulation factor VIII and IX products in children with congenital hemophilia.
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