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Table of Contents (English)
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Regulatory & Compliance
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- PMDA Consultation Guide for Foreign Companies | RS Consultation | JPRO
- Guide to Selecting Regulatory Affairs Staff and Consultants
- Expedited Review Systems for Pharmaceuticals
- Guidelines for Establishing Generic Drug Names
- Combination Products, Combination Medical Devices, Kit Products, Combination Drugs
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Medical Device, IVD
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- IVD, LDT, RUO
- DMAH: Designated Marketing Authorization Holder-Summary Ver.
- Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products
- How to determine if a product is a medical device
- Japan Medical Device Class I–IV｜JPRO
- Classification of Medical Devices
- how to confirm JMDN of medical device
- medical device & IVD reimbursement-Summary Ver.
- medical device & IVD reimbursemenet
- Comparison of Medical Device Definitions: Japan, US, & EU
- Companion Diagnostics and Gene Panel Testing
- Pharmaceutical, regenerative medicine >
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- References in English
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This portal supports international healthcare enterprises and innovators expanding into the Japanese market. Operated as a pro bono initiative by an advisor to Japanese public institutions, the site is designed to equip you with the knowledge needed to advance your business proactively, without over-reliance on external consultants. From regulatory affairs to business setups, all content is sourced only from highly reliable public institutions. ©2026 JPRO |