Licensing Requirements in Healthcare and Pharmaceuticals in Japan: What Foreign Companies Should Know 

Japan’s healthcare and pharmaceutical sectors represent one of the most advanced and highly regulated markets in the world. For foreign companies seeking to manufacture, import, or distribute pharmaceuticals, medical devices, cosmetics, or regenerative medicine products in Japan, understanding the licensing requirements is essential.

This article outlines the key regulatory authorities, major license categories, and practical steps foreign businesses should take before entering Japan’s life sciences market.

For inquiries, contact: TSL Partners – International Business Desk

1. Regulatory Authorities and Legal Framework

Healthcare and pharmaceutical products in Japan are primarily regulated under the Pharmaceuticals and Medical Devices Act (PMD Act), along with related laws such as the Act on Securing Quality, Efficacy and Safety of Products and the Act on the Safety of Regenerative Medicine.

Key regulatory bodies include:

• Ministry of Health, Labour and Welfare (MHLW) – the central authority setting overall policy and approving licenses.
• Pharmaceuticals and Medical Devices Agency (PMDA) – responsible for reviewing applications, conducting safety evaluations, and post-market surveillance.
• Prefectural Governments – handle regional licensing (e.g., retail sale and distribution permits).

Foreign businesses must also be aware that only Japanese-registered entities can hold most types of manufacturing or marketing authorizations, meaning a local subsidiary or designated representative is required.

2. Key Licensing Categories

i) Pharmaceuticals

To manufacture or sell pharmaceuticals in Japan, several licenses are required:

• Manufacturing License (Seizō Kyoka) – for facilities that physically produce the product.
• Marketing Authorization Holder (MAH) License (Seizō Hanbai Gyō Kyoka) – for companies that assume legal responsibility for marketing and quality assurance.
• Sales Business License – for wholesale or retail distribution.

Foreign manufacturers must register as a Foreign Manufacturer (Gaikoku Seizō Gyōsha Tōroku) with the MHLW before exporting products to Japan.

ii) Medical Devices

Medical devices are classified into four risk-based categories (Class I–IV).

• Class I (low risk) products may be self-notified.
• Class II–IV require certification or approval by the PMDA.
  Manufacturers must comply with Japan’s Good Manufacturing Practice (GMP) and Quality Management System (QMS) standards.
  Foreign device manufacturers must also appoint a Designated Marketing Authorization Holder (DMAH) in Japan.

iii) Cosmetics

Japan operates a notification-based system for cosmetics. A local entity must obtain a Cosmetic Manufacturing and Sales License and submit a Product Notification (Nintei) before marketing.
All ingredients and product labels must comply with Japanese standards under the PMD Act and the Fair Labeling and Advertising Act.

ⅳ) Regenerative Medicine and Biologics

Regenerative medicine products (such as stem cell–based therapies or gene therapies) are subject to special frameworks under the Act on the Safety of Regenerative Medicine.

These products require:

• PMDA review for safety and efficacy;
• Clinical trial approval; and
• Post-marketing surveillance.
  Japan allows conditional and time-limited approval to accelerate market entry for innovative therapies.

3. Application and Approval Process

Typical steps for obtaining approval include:

1. Pre-consultation with PMDA or MHLW
   – Clarify product classification and regulatory pathway.
2. Submission of Technical Documentation
   – Include product data, test results, GMP/QMS certifications, and Japanese-language labeling.
3. Review and Inspection
   – PMDA review may take 6–18 months depending on the product type.
4. Issuance of License
   – Once approved, the applicant receives authorization to manufacture or market.

Having a Japanese-speaking representative and properly translated documentation is critical to avoid delays.

4. Compliance and Post-Market Obligations

After obtaining the required licenses, companies must maintain ongoing compliance with Japan’s strict quality, safety, and reporting requirements. License holders are obligated to establish and operate internal systems for Good Quality Practice (GQP) and Good Vigilance Practice (GVP) to ensure continuous product quality and safety management.

They must also conduct periodic reporting to the PMDA, manage recalls or adverse event reports, and undergo inspections by relevant authorities as needed.
Labeling and advertising must comply with Japanese law, prohibiting exaggerated or misleading health claims.

Failure to comply with these requirements may lead to administrative penalties, license suspension, or even criminal sanctions—making continuous monitoring and internal audits essential.

5. Practical Tips for Foreign Entrants

• Appoint a reliable Japanese representative or DMAH to act as your local license holder.
• Engage specialized advisors (e.g., lawyers, administrative scriveners, or regulatory consultants) to navigate PMDA procedures.
• Localize documentation – Japanese-language materials are mandatory for most filings.
• Plan sufficient lead time – Licensing and approval may take several months to over a year.
• Align your business structure – Some licenses must be held by a Japanese company rather than a foreign parent.

Conclusion

Japan’s healthcare and pharmaceutical market offers significant opportunities—but it also demands strict regulatory compliance.
Foreign companies should start with a clear understanding of the PMD Act, secure proper representation in Japan, and seek expert guidance to ensure a smooth market entry.

For inquiries, contact: TSL Partners – International Business Desk

For an overview of Japan’s company setup process, see:

[Incorporating a Business in Japan: Legal and Strategic Guide for Foreign Companies]
For information on director and shareholder compliance, see:

[Legal Compliance for Foreign Directors and Shareholders in Japan]
For general licensing guidance, see:

[Fintech and Payment Services in Japan: Regulatory Overview]