Japan maintains a dense web of sector-specific licenses and permits, collectively referred to as kyoninka (許認可). Many foreign companies discover these requirements only after incorporation, sometimes after they have already signed a lease or hired staff. This guide maps the major 許認可 categories that foreign-owned entities operating in Japan are most likely to encounter, explains how each relates to the corporate registration process, and identifies the responsible ministry for each.
What Is Kyoninka (許認可) and Why Does It Matter for Foreign-Owned Entities?
許認可 (kyoninka) is a composite term covering three distinct administrative concepts:
(a) kyoka (許可): A positive authorization from a competent authority that lifts a statutory prohibition. Operating a food business, running a labor dispatch operation, or carrying out pharmaceutical manufacturing all require 許可 from the relevant ministry or local authority. Without it, the activity is unlawful regardless of corporate registration status.
(b) ninka (認可): An administrative act that validates a legal act or plan, for example, approval of a business transfer agreement in a regulated sector.
(c) 登録 / toroku / todoke-de, registration / notification (届出): A lighter-touch regime in which the operator notifies an authority or registers with it, sometimes subject to a review period. PSE Notifying Supplier (届出事業者) registration and customs code registration fall into this category.
For foreign-owned entities, the 許認可 layer matters for three reasons. First, the license is typically issued to the Japan legal entity, not to the overseas parent, so the Japan entity must exist and meet the financial and personnel requirements before an application can be accepted. Second, many licenses require a named responsible person (法人の役員, hojin no yakuin, or a licensed professional in-house), which affects hiring and governance decisions. Third, operating without the required 許可 exposes both the company and its representative director to criminal liability, not merely administrative fines.
Incorporation and Business Licensing Are Separate Legal Steps
A common misconception among foreign market entrants is that completing corporate registration under Companies Act (会社法) is the same as obtaining permission to operate. It is not.
Incorporation under 会社法 creates a legal person capable of entering contracts, owning assets, and bearing liabilities. It does not confer any operating permission. A freshly registered KK, Kabushiki Kaisha (株式会社) or GK, Godo Kaisha (合同会社) with a business purpose clause mentioning food retail, labor dispatch, or pharmaceutical sales is still prohibited from conducting those activities until the corresponding 許可 has been issued.
The practical implication is sequencing. You can incorporate a KK before obtaining an industry license, and in many cases you must do so, because the application for a license requires a registered Japan corporate entity. However, you cannot begin regulated operations until the license is in hand. The gap between incorporation and license issuance can be weeks or several months, depending on the sector and ministry processing times.
Import and Export: What a Trading Company (商社) Needs
Japan has no general "import license" required of all importers. Any company with a valid Japan corporate registration and a customs code (輸出入者コード, yushutsunyu-sha-kodo, importer/exporter code, issued by Japan Customs) can import most ordinary commercial goods.
However, several additional permits become relevant for specific goods or business models:
(a) Customs Code (輸出入者コード). Every company that files import or export declarations with Japan Customs must obtain a customs code. This is a registration procedure, not a substantive licensing requirement, but it is foundational. Applications go to the regional customs office covering your port or the NACCS (輸出入・港湾関連情報処理センター, Nippon Automated Cargo and Port Consolidated System) center.
(b) Product-category-specific import permits. Certain goods require prior authorization from the competent ministry regardless of who is importing: food products require compliance with Food Sanitation Act (食品衛生法), electrical products require PSE compliance under Electrical Appliance and Material Safety Act (電気用品安全法), and radio-frequency devices require gitekigo (技適) certification under Radio Act (電波法). The importer carries responsibility for compliance.
(c) Export control notifications. Exports of goods or technology listed under the Foreign Exchange and Foreign Trade Act / FEFTA (外為法) may require prior permission from METI (経済産業省, Ministry of Economy, Trade and Industry). This is a separate regulatory vertical addressed in Aplash's dedicated export control guidance.
A shosha (商社) with a broadly drafted teikan, Articles of Incorporation (定款) mokuteki (目的) clause is administratively positioned to import and export. It still must comply with every product-specific regime applicable to its goods.
Retail and Food Sector: Food Sanitation Act (食品衛生法) Requirements
Any entity that manufactures, processes, prepares, packages, stores, transports, or sells food in Japan is subject to Food Sanitation Act (食品衛生法), which is administered at the municipal level through hokenjo, Public Health Centers (保健所).
shokuhin eigyo kyoka, Food Business Permit (食品営業許可) is required for a wide range of food-handling operations, including:
(a) Restaurants, cafes, and catering operations.
(b) Food processing and manufacturing facilities.
(c) Baked goods production.
(d) Import and wholesale distribution of fresh food products.
The permit is issued by the 保健所 covering the facility address. The key conditions include a compliant physical facility (kitchen layout, materials, ventilation, sanitation equipment), a named shokuhin-eisei sekininsha (食品衛生責任者) for each facility who has completed a prescribed training course, and a facility inspection by the 保健所 before operations begin.
Foreign-owned entities frequently underestimate the facility compliance requirements. A kitchen space that meets the operator's home-country standards may fail a Japan 保健所 inspection because of differences in wall material specifications, drainage requirements, or the separation of preparation zones. Engaging a local architect familiar with 保健所 requirements before buildout is strongly advisable.
A 2021 amendment to 食品衛生法 introduced a HACCP-based sanitation management obligation for all food business operators. Companies that previously operated under a general hygiene management standard must now document and implement HACCP-based or HACCP-equivalent procedures.
Medical and Pharmaceutical: PMD Act (薬機法) Marketing Authorization
The Pharmaceutical and Medical Devices Act (薬機法), administered by MHLW (厚生労働省, Ministry of Health, Labour and Welfare) through PMDA (医薬品医療機器総合機構, Pharmaceuticals and Medical Devices Agency), is one of the most complex regulatory frameworks a foreign company will encounter in Japan.
For a foreign company seeking to sell medical devices or pharmaceutical products in Japan, two key concepts define the licensing structure:
(a) iryokiki seizohanbai-gyo kyoka, Medical Device Marketing Authorization Holder license (医療機器製造販売業許可). A Japan-resident entity must hold this license to place a medical device on the Japanese market. The Marketing Authorization Holder (MAH) is legally responsible for the product's safety, quality, and labeling, and for all post-market surveillance obligations.
(b) 製造販売承認 / 認証 / seizohanbai-shonin / ninsho / todoke-de, marketing approval / certification / notification (届出). Each individual device also requires a product-level registration, at a tier determined by device class: Class III and IV devices require full PMDA approval; Class II devices typically require daisan-sha ninsho-kikan (第三者認証機関) certification; Class I devices require notification.
A foreign company that does not have a Japan entity and does not obtain a MAH license cannot legally sell medical devices in Japan, irrespective of international certifications (CE mark, FDA clearance). Appointing a Japan-based MAH, either a third-party commercial MAH or a wholly owned Japan entity, is the required market entry path.
Financial Services: FIEA (金融商品取引法) Licenses
Financial services in Japan are regulated under Financial Instruments and Exchange Act, FIEA (金融商品取引法), administered by the FSA (金融庁, Financial Services Agency). Financial services licensing is not Aplash's core service vertical, but the framework is worth understanding for foreign companies whose Japan operations touch financial products or investment advisory.
The principal registration categories relevant to market entrants are:
(a) toshi-jogen dairi-gyo, Investment Advisory and Agency Business (投資助言・代理業). Required for companies providing investment advice about securities or derivatives for compensation. Registration is with the relevant local finance bureau (財務局, zaimu-kyoku).
(b) dai-isshu kin'yu-shohin torihiki-gyo, Type I Financial Instruments Business (第一種金融商品取引業). Required for dealing in listed securities, operating securities exchanges, or underwriting. The capital requirements for Type I registration are substantially higher than for investment advisory.
(c) dai-nishhu kin'yu-shohin torihiki-gyo, Type II Financial Instruments Business (第二種金融商品取引業). Covers dealing in fund interests and other collective investment schemes not covered by Type I.
Operating financial advisory or fund management activities in Japan for Japanese clients without the appropriate FIEA registration exposes a company to criminal penalties: up to three years' imprisonment or a fine of up to JPY 3 million for individuals. Foreign companies that advise Japanese clients from offshore are not automatically exempt; the FSA applies an extraterritorial analysis based on whether solicitation activities occur in Japan. Companies in this area should obtain specialist FSA regulatory counsel before commencing any activities.
Staffing and Labor Dispatch: Labor Dispatch License (労働者派遣事業許可)
Companies that dispatch workers to client businesses in Japan must obtain a rodo-sha-haken-jigyo kyoka, Labor Dispatch Business License (労働者派遣事業許可) under rodo-sha-haken-ho, Worker Dispatching Act, R1 (労働者派遣法), administered by MHLW.
Key structural requirements for licensure include:
(a) Capital adequacy. The licensed entity must maintain a minimum asset base. The basic threshold is assets of at least JPY 20 million after deducting liabilities, with cash and deposits of at least JPY 15 million. These thresholds apply per business location for multi-site operators.
(b) Named haken-moto-sekininsha, Dispatching Employer Responsible Person (派遣元責任者). Each licensed office must designate a qualified responsible person who has completed MHLW-designated training.
(c) Registered address with facilities. The license requires a permanent business location with independent facilities, not merely a virtual office address.
The license is issued by the prefectural Labour Bureau (都道府県労働局, todo-fu-ken-rodo-kyoku) with jurisdiction over the applicant's principal office.
A distinction that matters for foreign companies: labor dispatch (労働者派遣) is structurally different from ukeoi (請負). In dispatch, the dispatching company directs the workers to a client's worksite and the client exercises day-to-day operational control. In ukeoi, the subcontractor retains operational control. Misclassifying a dispatch arrangement as ukeoi to avoid licensing is a known compliance failure mode and triggers enforcement action under both 労働者派遣法 and Labor Standards Act (労働基準法).
Real Estate: Real Estate Brokerage License (宅地建物取引業免許)
Companies that act as agents or brokers in the purchase, sale, exchange, or leasing of land and buildings for compensation must hold a takuchi-tatemono-torihiki-gyo-menkyo, Real Estate Brokerage License (宅地建物取引業免許) under takuchi-tatemono-torihiki-gyo-ho, Real Estate Brokerage Act, R1 (宅地建物取引業法).
The license is issued by:
(a) The prefectural governor (都道府県知事) for companies operating in a single prefecture.
(b) The MLIT (国土交通大臣, Minister of Land, Infrastructure, Transport and Tourism) for companies with offices in two or more prefectures.
Key requirements include: a physical office in each prefecture of operation, at minimum one takuchi-tatemono-torihiki-shi, Real Estate Transaction Specialist, colloquially "Takken" (宅地建物取引士) per five employees, and financial requirements (営業保証金, eigyo-hoshokin, business security deposit, or membership in a 保証協会, hosho-kyokai, guarantee association).
Foreign-owned companies building residential or commercial real estate portfolios in Japan often initially act only as principals (buying and holding for their own account), which does not require a brokerage license. The license is triggered when acting as an agent or broker on behalf of third parties. Companies that intend to offer real estate investment advisory or brokerage services to external clients must obtain this license before executing any brokered transactions.
Electrical Products and PSE: DENAN (電気用品安全法) Registration
Electrical and electronic products sold in Japan must comply with Electrical Appliance and Material Safety Act, DENAN (電気用品安全法), administered by METI.
The compliance path depends on the product category:
(a) tokutei-denki-yohin, Specified Electrical Appliances and Materials (特定電気用品). Higher-risk products (certain cables, circuit breakers, transformers). Require conformity assessment by a registered third-party body and carry the PSE diamond mark (菱形PSE).
(b) hi-tokutei-denki-yohin, Non-Specified Electrical Appliances and Materials (特定電気用品以外の電気用品). Lower-risk consumer products (household appliances, audio equipment). Require self-declaration of conformity under a registered Notifying Supplier and carry the PSE circle mark (丸形PSE).
In both cases, the entity that places the product on the Japanese market must be registered as a todoke-de-jigyo-sha, Notifying Supplier (届出事業者) with METI. For a foreign manufacturer with no Japan entity, registration is not possible directly; the foreign company must either establish a Japan entity that registers as Notifying Supplier, or appoint an existing Japan-registered Notifying Supplier (such as Aplash, acting in that capacity) to carry the registration and compliance obligation for their products.
PSE non-compliance blocks customs clearance. Products arriving at a Japan port without the correct PSE marking and without a registered Notifying Supplier on record will be stopped at customs.
Import Registration: No General Import License, but Customs Registration Is Required
Japan does not maintain a general "import license" applicable to all importers. Any corporate entity with a valid 輸出入者コード registered with Japan Customs can file import declarations. However, several administrative registrations are foundational for companies whose operations center on importing:
(a) Customs Code (輸出入者コード). Required to file import declarations through NACCS. Obtained by application to the nearest regional customs authority with corporate registration documents.
(b) AEO (Authorized Economic Operator) status. Not mandatory, but companies with high import volumes may apply for AEO status (特例輸入者, tokunyu-yunyusha). AEO status provides simplified customs procedures, reduced examination rates, and priority processing.
(c) Bonded warehouse operations. Companies that wish to store imported goods in a customs-controlled zone before deciding to clear them into Japan or re-export must operate through or apply to establish a hozei-chokijo (保税蔵置場). Operating a bonded warehouse requires a separate license from the regional customs director.
For companies using an Importer of Record (IOR) structure, the IOR entity holds the customs code and bears legal importer responsibility. The overseas seller does not need to register directly with Japan Customs.
Common Mistake: 定款 目的 Clauses Are Not Licenses
A recurring error in foreign-company Japan market entry: drafting a 定款 mokuteki (目的) clause that lists a regulated activity, and treating that as operational clearance.
It is not.
The 目的 clause in a Articles of Incorporation (定款) declares the scope of permissible corporate activity under 会社法. It establishes that the company is legally capable of conducting that business. It does not substitute for any industry-specific 許可, 認可, or 登録 required by a sectoral law.
A KK whose 定款 states "食品の製造・販売業" (food manufacturing and sales) is a company lawfully capable of entering the food sector. It is not a company that has a 食品営業許可. A company whose 定款 includes "労働者派遣事業" (labor dispatch business) does not have a 労働者派遣事業許可 until it applies for and receives one from MHLW.
The practical risks of this confusion:
(a) Commencing operations without a required license creates criminal exposure for the representative director.
(b) Some licenses require operational history or facility inspections before issuance, meaning that a company cannot simply "apply on day one and start operating."
(c) Certain licenses impose conditions on the 定款 text itself. If the 定款 目的 does not include the specific activity language required by the licensing ministry, the license application may be rejected, requiring a 定款 amendment before reapplication.
Timeline and Sequencing: Licenses Relative to Incorporation and Launch
No single sequencing applies to all industries, but a general framework holds:
(a) Pre-incorporation phase. Identify every license your Japan business model will require before completing incorporation. Confirm the requirements with the responsible ministry or a qualified advisor. Some licenses impose conditions (minimum capital, facility type, in-house personnel qualifications) that must be built into the corporate setup from the start.
(b) Incorporation. Register the KK or GK under 会社法. Ensure the 定款 目的 clause includes the activity language required by each planned license application. Capitalize the company at or above any minimum thresholds required by the licensing regime.
(c) License application phase. File applications with the competent ministry or local authority. Processing times vary widely: a 食品営業許可 from a 保健所 can be issued in two to four weeks following a successful facility inspection; a 労働者派遣事業許可 from the Labour Bureau typically takes two to three months; FIEA registration can take three to six months or longer.
(d) Operational launch. Begin regulated activities only after the license is in hand, not on application submission. The application pending period is not a grace period.
(e) Ongoing compliance. Most licenses carry renewal obligations (typically annual or every five years), change notification requirements (for changes to responsible persons, office addresses, or capital), and continuing operational conditions. Factor these into post-launch compliance calendars.
How Aplash Helps
Aplash is a regulatory strategy and market entry firm. In the licensing context, our role covers:
(a) Regulatory mapping. Before incorporation, we identify all 許認可 requirements applicable to your specific business model and product categories, across the relevant ministries and local authorities.
(b) Application preparation. We prepare the documentation packages required for license applications, coordinate with authorities during the review period, and manage the facility inspection scheduling process for permits that require an on-site check.
(c) 定款 目的 alignment. We ensure your 定款 is drafted with the correct business purpose language to support each intended license application, preventing the need for costly amendments after incorporation.
(d) Ongoing compliance structure. Post-license issuance, we advise on the renewal calendar, change notification requirements, and operational conditions imposed by the license terms.
We do not act as licensed legal counsel (弁護士, bengoshi) or as a registered gyoseishoshi, Administrative Scrivener (行政書士) for the formal submission of license applications where those roles are legally required. For those formal submission steps, we coordinate with qualified professionals. What we provide is the regulatory strategy and preparation layer: knowing what to apply for, when, and in what form.
Conclusion
Japan's 許認可 (kyoninka) framework is broad, ministry-specific, and independent from the corporate registration process. The most effective approach is to map the license requirements for your specific sector before incorporating, structure the entity to satisfy the licensing conditions from the start, and treat the license issuance date, not the incorporation date, as the operational start point for any regulated activity.
This article is informational only and does not constitute legal, tax, or regulatory advice. Consult a qualified advisor before acting on the content. Last updated: 2026-06.