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Table of Contents (English)
- Business Setup & Operations >
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Regulatory & Compliance
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- 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
- 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 >
- Licensing, partnering >
- References in English
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Author：上谷 和司（Kaz Kamitani）
厚労省、経産省、中小機構、東京都等自治体のスタートアップ支援機関にてアドバイザーを務める。 Serving as advisor and mentor at startup support programs under MHLW, METI, SME Support Japan, Tokyo Metropolitan Government, and other local governments. 本サイトは、スタートアップや研究者が十分な知識を持った上で主体的に事業化を進められるよう支援することを目的とし、プロボノ活動の一環として運営しています。公的機関の一次資料に基づく情報と、アドバイザーとしての著者の知見を提供しており、当オフィスを含め特定の民間企業や有償サービスの紹介はしておりません。 This site is operated as a pro bono initiative, with the mission of equipping startups and researchers with the knowledge they need to take the lead in building their businesses. It offers information based on primary sources from government agencies, combined with insights from the author's experience as a public institution advisor. We do not introduce or endorse any specific private companies or paid services, including our own. Ⓒ2026 JPRO |