Topic
PMDA
2 articles
Regulatory
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
22 min read2026-07-16
›PMDA
PMDA eCTD v4.0 for Medical Devices: Complete Transition Guide After the April 2026 Mandate
Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. Learn what changed, Module 1 expectations, device submission issues, and compliance steps.
21 min read2026-04-30
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