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Table of Contents (English)
- Business Setup & Operations >
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Regulatory & Compliance
>
- PMDA consultation
- regulatory considerations when using person infformation
- 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
>
- 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
- medical device classification for combined products
- Classification of Medical Devices
- how to confirm JMDN of medical device
- medical device & IVD reimbursement-Summary Ver.
- medical device & IVD reimbursemenet
- insurance reimbursement for SaMD
- Comparison of Medical Device Definitions: Japan, US, & EU
- Companion Diagnostics and Gene Panel Testing
- Pharmaceutical, regenerative medicine >
- Healthcare & Caretech Products >
- Funding, Partnering & Networking >
- Intellectual Property >
- Legal & Contracts >
- Academia & Tech Transfer
- Licensing, partnering >
- References in English
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Ⓒ2026 JPRO
We are the pro bono navigator for life science/healthcare startups & entrepreneurs. Our website provides a centralized repository of essential information required for market entry.
All content on this site is based on primary resources issued by government agencies and public organizations, with direct source URLs provided for every key point. ] JPRO and its representative have served as advisors, supporters, and mentors for years within the primary public institutions driving Japan’s healthcare startup ecosystem: funded by Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and major local governments like Tokyo. |