Portal for life science/healthcare startups
  • Home
    • English Top
    • 日本語トップ
  • Table of Contents (English)
    • Business Setup & Operations >
      • Startup Visa
      • setting up in Japan
      • Company establishment
      • Life Science Hub, Startup Hub
    • 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
    • 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 >
      • How to determine if a product is a Pharmaceutical Drug
      • Advanced Medical Care System
      • Over-The-Counter (OTC) Drug
      • References on Reimbursement (Cost Calculation) for Regenerative Medical Products
    • Healthcare & Caretech Products >
      • guidance for non medical services
      • Therapeutic Orthoses and Assistive Devices
      • Cosmetics and Quasi-Drugs
      • Overseas Expansion of Non-Medical Device Products as Medical Devices: Learning from the Case of PARO
    • Funding, Partnering & Networking >
      • Utilization of Public Grants and Subsidies
      • J-Ships
    • Intellectual Property >
      • patent or trade secret?
      • employee invention
      • Matching of Patents Held by Startups and Individuals
    • Legal & Contracts >
      • References for Contracts
      • Guide to Industry-Academia Collaboration Agreements for Academic Researchers
    • Academia & Tech Transfer
    • Licensing, partnering >
      • Networking, Partnering
      • Introducing Seeds to Pharmaceutical Companies
      • Incentives (Returns) to Licensor Universities
    • References in English
  • コンテンツ一覧
    • 起業、法人設立・運営 >
      • 事業計画の策定
      • 法人設立
      • ライフサイエンスハブ、スタートアップハブ
    • 公的支援 >
      • 公的支援機関リスト
      • 実証実験支援プログラム一覧
      • 大学発スタートアップ支援機関・プログラムガイド
      • AMED Medical IP Desk
      • MEDISO活用のススメ
    • 薬事・規制関連 >
      • PMDA RS相談活用のススメ
      • 薬事スタッフ・コンサル選定ガイド
      • 都道府県薬務課一覧
      • コンビネーション製品、組合せ医療機器、キット製品、組合せ医薬品
    • 医薬品、再生医療等製品 >
      • 医薬品の該当性確認方法
      • 医薬品一般的名称設定のガイドライン
      • 医薬品、医療機器等の開発に当たって、参照したい資料
      • 先進医療制度
      • 一般用医薬品(OTC)
      • コンパニオン診断薬と遺伝子パネル検査
      • 再生医療等製品の保険償還(原価計算)に関する参考情報
    • 医療機器、体外診断用医薬品 >
      • 体外診、ラボ開発検査、研究用試薬
      • 医療機器該当性確認ガイド
      • 医療機器と非医療機器の機能が複合した製品は?
      • 医療機器の一般的名称と確認方法
      • 医療機器のクラス分類
      • 医療機器・体外診の保険収載概要
      • 医療機器・体外診の保険収載実務
      • SaMDの保険収載
      • 医療機器・体外診の保険収載ガイド
    • ヘルスケア・ケアテック >
      • 非医療分野の検査サービスを展開する際に注意すべきポイント
      • 治療用装具と補装具
      • 化粧品及び医薬部外品
      • 医療機器とするか、非医療機器とするか
    • 資金調達 >
      • 公的な助成金、補助金の活用
      • 特定投資家向け銘柄制度(J-Ships)
      • アカデミア研究者がPIとして応募可能なグラントリスト
      • 海外在住の日本人研究者が日本の助成金を獲得する方法
    • 知的財産 >
      • 特許か?営業秘密か?
      • 職務発明:アカデミア・公的研究機関に所属する研究者が注意すべきポ
      • スタートアップや個人が保有する特許のマッチング
      • ライセンスを受けた大学へのインセンティブ(還元)について
    • 法務・契約 >
      • 契約関連で参考になる公的機関の資料
      • 個人情報を利用する製品開発時に留意すべき法規制
    • アカデミア、技術移転 >
      • アカデミア研究者のための産学連携契約ガイド
    • ライセンシング、パートナリング >
      • 製薬企業等へのシーズ紹介
      • ネットワーキング、パートナリング
    • 海外展開 >
      • 米国展開(主に医療機器)に、読むと役立つ情報リスト
      • 米国FDAにおける、医療機器該当性の確認ステップ
      • 米国における、医療機器の申請データ・試験計画の相談方法((Pre-Submission/Q-Submission
      • 公的機関の海外展開支援
      • 横浜市の公的支援サービス
      • JETROを徹底活用しよう
      • 日米欧での医療機器定義の比較
      • 簡略審査(審査の迅速化)
      • 海外規制等の情報収集
      • 非医療機器製品の海外での医療機器展開
      • 欧州医療機器規則MDRに関する資料
      • 欧州MDRにおける、医療機器該当性の確認方法
    • オーストラリア >
      • オーストラリア研究開発優遇税制の概要
      • オーストラリア研究開発優遇税制の適用を受けるには
      • オーストラリアでの主要イベント
      • R&D関連の公的機関
      • オーストラリア助成金情報

Setting up in Japan
​

Japan is a major opportunity — but entry takes planning.
This guide helps life science and healthcare startups understand what it really takes to set up in Japan, before you commit.




Part 1: Before You Move — Think Carefully

Japan is one of the world's largest life science and healthcare markets, and for many foreign startups it represents a compelling opportunity. However, entering Japan requires more preparation than most founders expect. Before committing to establishing a legal entity, you should honestly evaluate whether formal incorporation is truly necessary at this stage of your business.
The following factors are commonly underestimated by overseas founders and should be carefully weighed.
Cost and Expected Return The direct and indirect costs of maintaining a Japanese subsidiary are significant. Company registration fees, mandatory auditing, local accounting and legal compliance, office rental, and HR administration add up quickly — often reaching several million yen per year even for a lean operation. Before incorporating, map out a realistic Japan revenue timeline. If meaningful returns are not expected within 12–24 months, a lighter-touch market entry vehicle may serve you better.
Language Japanese is the language of business in Japan. Contracts, regulatory filings, government correspondence, and most partner negotiations are conducted in Japanese. This means you will depend heavily on bilingual staff or external translators, and miscommunication risk is real. Building a team with strong Japanese-language capability takes time and budget.
Local Business Culture Japanese business culture places high value on trust-building, consensus decision-making (nemawashi and ringi), and long-term relationships. Deal cycles are typically much longer than in Western markets. New foreign entrants with no local track record may find doors slow to open. A local partner who can vouch for you accelerates this process considerably.
Difficult Termination Japanese labor law strongly protects employees, making it legally complex and costly to downsize or exit the market once you have hired local staff. A company with even a handful of Japanese employees can face a process spanning 12 to 24 months if it needs to wind down operations. This is not a reason to avoid Japan, but it underscores the importance of starting carefully and scaling deliberately.
Decision-Making Speed Enterprise sales cycles in Japan can run 12 to 18 months or longer. Hospital and government procurement processes are particularly lengthy. Factor this into your cash planning and do not assume that signing a partnership MOU translates quickly into revenue.
Fundraising Challenges for Foreign Firms Foreign-affiliated companies often find it harder to raise capital from Japanese domestic VCs, which tend to prefer locally-headquartered entities with established local teams. Public grants and subsidies — including from AMED and regional governments — may also be more accessible to companies with a stronger local presence. If fundraising in Japan is part of your strategy, build your local credibility early.

Part 2: Our Recommendation
Start with Local Partners, Not a Subsidiary It would be wise to utilize local partners at least in the early stage, without incorporating. A trusted Japanese partner — a distributor, CRO, CMO, licensing partner, or business development agent — can serve as your market entry vehicle. This approach lets you validate your product-market fit, build relationships, and learn the regulatory landscape without bearing the full cost and legal obligations of a subsidiary.
If You Only Need an Office If you simply need a base of operations in Japan — for business meetings, regulatory activities, or occasional team visits — we recommend utilizing a shared office within one of Japan's life science hubs rather than signing an independent office lease.
Life science hubs offer more than just desk space. Co-location with peer companies, access to specialized infrastructure, and built-in networking opportunities make these environments uniquely valuable for startups in pharma, medical devices, and digital health. Establishing a presence within a hub, even informally, signals seriousness to Japanese partners and investors.
If You Really Need to Incorporate If, after careful consideration, you have determined that establishing a Japanese legal entity is necessary, the following resources are your starting points.
JETRO (Japan External Trade Organization) is the Japanese government's official investment promotion agency, and your most important first contact. JETRO offers free consultation services, bilingual guides, and hands-on support for foreign companies setting up in Japan.
  • Setting Up Business guide (covers entity types, company registration, visa, taxation, and HR, with video walkthroughs): https://www.jetro.go.jp/en/invest/setting_up/
  • Initiatives for attracting foreign companies to regional ecosystems: https://www.jetro.go.jp/en/invest/jetros_support/localgovernments.html
  • Navigation system for investing in Japan's local regions: https://www.jetro.go.jp/en/invest/region/
Tokyo One-Stop Business Establishment Center — If you are targeting Tokyo, the Tokyo Metropolitan Government sponsors a range of free support services for foreign companies, covering company registration, finding office space, and more. https://www.startup-support.metro.tokyo.lg.jp/onestop/en/
In addition to these resources, always consult your country's embassy trade or commercial section in Tokyo. Both JETRO and embassies offer free consultations and can connect you with vetted service providers.

Part 3: Key Points for Incorporation
Securing a Registered Address Company registration in Japan requires a registered address (honten). This must be a real physical address — P.O. boxes are not accepted by the Legal Affairs Bureau. However, this does not mean you need to commit to a full office lease from day one.
In the early stages, using a virtual office (バーチャルオフィス) is the most cost-effective and time-efficient approach. A virtual office provides a legitimate registered address — often in a prestigious business district such as Marunouchi or Minami-Aoyama in Tokyo — without the overhead of a dedicated lease.
Choosing a Life Science Ecosystem For startups developing pharmaceuticals, medical devices, diagnostics, or digital health products, we strongly recommend establishing your registered office within or adjacent to a recognized life science ecosystem. Life science is a specialized field, and a general startup accelerator or shared office will not give you the same industry-specific access.
The benefits of ecosystem location include co-location with pharma, biotech, CRO, and CMO companies; access to specialized lab and office infrastructure; built-in business networking and matchmaking events; and stronger credibility with Japanese industry partners and investors who know the ecosystem.
If you are unable to establish your registered office within a life science hub, consider at minimum becoming a member or affiliate of a relevant ecosystem. Membership typically provides access to industry information and regulatory updates, networking events and educational programs, introductions to potential partners and customers, and visibility within the Japanese life science community.
Choosing Your Entity Type Japan offers several types of legal entities for foreign companies. The two most common choices for foreign life science startups are the Kabushiki Kaisha (KK) and the Godo Kaisha (GK).
  • Kabushiki Kaisha (KK) is the joint-stock company form and the most recognized corporate structure in Japan. It is preferred by Japanese pharmaceutical and medical device companies, hospitals, and government agencies as a partnership counterpart. KK registration involves higher setup costs (approximately 240,000 yen or more in fees) and requires notarization of the Articles of Incorporation, but it carries significantly higher credibility. Setup typically takes two to four weeks. A KK is the recommended choice for companies planning fundraising, regulatory approvals, or formal partnerships with Japanese enterprises.
  • Godo Kaisha (GK) is the Japanese equivalent of a limited liability company (LLC). It has a simpler governance structure, lower setup costs (approximately 60,000 yen or more in fees), and faster registration (typically one to two weeks). However, it is less familiar to many Japanese partners and may be viewed as a less serious commitment. A GK can be a practical starting point for companies testing the market with minimal overhead, with the option to convert to a KK later.
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About JPRO
Table of Contents
​
​オフィス概要
​コンテンツ一覧
Ⓒ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.

​
  • Home
    • English Top
    • 日本語トップ
  • Table of Contents (English)
    • Business Setup & Operations >
      • Startup Visa
      • setting up in Japan
      • Company establishment
      • Life Science Hub, Startup Hub
    • 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
    • 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 >
      • How to determine if a product is a Pharmaceutical Drug
      • Advanced Medical Care System
      • Over-The-Counter (OTC) Drug
      • References on Reimbursement (Cost Calculation) for Regenerative Medical Products
    • Healthcare & Caretech Products >
      • guidance for non medical services
      • Therapeutic Orthoses and Assistive Devices
      • Cosmetics and Quasi-Drugs
      • Overseas Expansion of Non-Medical Device Products as Medical Devices: Learning from the Case of PARO
    • Funding, Partnering & Networking >
      • Utilization of Public Grants and Subsidies
      • J-Ships
    • Intellectual Property >
      • patent or trade secret?
      • employee invention
      • Matching of Patents Held by Startups and Individuals
    • Legal & Contracts >
      • References for Contracts
      • Guide to Industry-Academia Collaboration Agreements for Academic Researchers
    • Academia & Tech Transfer
    • Licensing, partnering >
      • Networking, Partnering
      • Introducing Seeds to Pharmaceutical Companies
      • Incentives (Returns) to Licensor Universities
    • References in English
  • コンテンツ一覧
    • 起業、法人設立・運営 >
      • 事業計画の策定
      • 法人設立
      • ライフサイエンスハブ、スタートアップハブ
    • 公的支援 >
      • 公的支援機関リスト
      • 実証実験支援プログラム一覧
      • 大学発スタートアップ支援機関・プログラムガイド
      • AMED Medical IP Desk
      • MEDISO活用のススメ
    • 薬事・規制関連 >
      • PMDA RS相談活用のススメ
      • 薬事スタッフ・コンサル選定ガイド
      • 都道府県薬務課一覧
      • コンビネーション製品、組合せ医療機器、キット製品、組合せ医薬品
    • 医薬品、再生医療等製品 >
      • 医薬品の該当性確認方法
      • 医薬品一般的名称設定のガイドライン
      • 医薬品、医療機器等の開発に当たって、参照したい資料
      • 先進医療制度
      • 一般用医薬品(OTC)
      • コンパニオン診断薬と遺伝子パネル検査
      • 再生医療等製品の保険償還(原価計算)に関する参考情報
    • 医療機器、体外診断用医薬品 >
      • 体外診、ラボ開発検査、研究用試薬
      • 医療機器該当性確認ガイド
      • 医療機器と非医療機器の機能が複合した製品は?
      • 医療機器の一般的名称と確認方法
      • 医療機器のクラス分類
      • 医療機器・体外診の保険収載概要
      • 医療機器・体外診の保険収載実務
      • SaMDの保険収載
      • 医療機器・体外診の保険収載ガイド
    • ヘルスケア・ケアテック >
      • 非医療分野の検査サービスを展開する際に注意すべきポイント
      • 治療用装具と補装具
      • 化粧品及び医薬部外品
      • 医療機器とするか、非医療機器とするか
    • 資金調達 >
      • 公的な助成金、補助金の活用
      • 特定投資家向け銘柄制度(J-Ships)
      • アカデミア研究者がPIとして応募可能なグラントリスト
      • 海外在住の日本人研究者が日本の助成金を獲得する方法
    • 知的財産 >
      • 特許か?営業秘密か?
      • 職務発明:アカデミア・公的研究機関に所属する研究者が注意すべきポ
      • スタートアップや個人が保有する特許のマッチング
      • ライセンスを受けた大学へのインセンティブ(還元)について
    • 法務・契約 >
      • 契約関連で参考になる公的機関の資料
      • 個人情報を利用する製品開発時に留意すべき法規制
    • アカデミア、技術移転 >
      • アカデミア研究者のための産学連携契約ガイド
    • ライセンシング、パートナリング >
      • 製薬企業等へのシーズ紹介
      • ネットワーキング、パートナリング
    • 海外展開 >
      • 米国展開(主に医療機器)に、読むと役立つ情報リスト
      • 米国FDAにおける、医療機器該当性の確認ステップ
      • 米国における、医療機器の申請データ・試験計画の相談方法((Pre-Submission/Q-Submission
      • 公的機関の海外展開支援
      • 横浜市の公的支援サービス
      • JETROを徹底活用しよう
      • 日米欧での医療機器定義の比較
      • 簡略審査(審査の迅速化)
      • 海外規制等の情報収集
      • 非医療機器製品の海外での医療機器展開
      • 欧州医療機器規則MDRに関する資料
      • 欧州MDRにおける、医療機器該当性の確認方法
    • オーストラリア >
      • オーストラリア研究開発優遇税制の概要
      • オーストラリア研究開発優遇税制の適用を受けるには
      • オーストラリアでの主要イベント
      • R&D関連の公的機関
      • オーストラリア助成金情報