- Home
-
Table of Contents (English)
- Business Setup & Operations >
- Public Support >
-
Regulatory & Compliance
>
- 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
-
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
-
コンテンツ一覧
|
本サイトは、ヘルスケア領域での起業・社会実装を目指す方のための情報サイトです。公的機関でアドバイザーを務める著者が、起業者が十分な知識を持ち、外部に過度に依存せず主体的に事業化を進められるよう、プロボノ活動の一環として運営しています。薬事等の法規制から資金調達、事業開発、知財など必要な情報を一元的に収集できます。掲載情報は公的機関の一次資料に基づいており、また、特定の民間企業や有償サービスへの誘導はありません。
This site supports entrepreneurs and innovators in healthcare. Operated as a pro bono initiative by the author—an advisor at public institutions—it aims to help them advance their ventures independently and proactively, equipped with sufficient knowledge. From legal and regulatory affairs to fundraising, business development, intellectual property, and more, essential information is available in one place, based on primary sources from government agencies. Ⓒ2026 JPRO |