All Regions
Pharmaceuticals & Medical Devices Agency
🇯🇵 Japan — PMDA
Shonin/Ninsho approval strategy, Marketing Authorisation Holder support, and JGMP alignment.
Pathways & support
We support manufacturers through the Pharmaceuticals & Medical Devices Agency framework — from strategy and documentation to submission and post-market obligations.
- Shonin (approval) / Ninsho (certification) strategy
- Marketing Authorisation Holder (MAH) support
- JGMP-aligned quality evidence
- Foreign manufacturer registration
Get Started
Tell us about your device and target markets.
Share your device and regions of interest and our team will respond with a tailored regulatory outline within two business days.