Japan Cosmetic Registration Service
Navigate complex local regulations with our expert guidance. From product registration to designated representation services.
Regulatory Background
The regulatory framework for cosmetics (broadly defined as beauty products) in Japan is governed by the Pharmaceuticals and Medical Devices Act (PMDL). This framework is overseen by the Ministry of Health, Labour and Welfare (MHLW) and jointly executed by the Pharmaceuticals and Medical Devices Agency (PMDA) and local prefectural governments.
The core of this regulatory system lies in the differentiated management of products, which are categorized into two main classes:
Cosmetics: Products intended to be applied to the human body by rubbing, sprinkling, or other methods for cleansing, beautifying, promoting attractiveness, altering the appearance, or keeping the skin or hair in healthy condition, provided that their action on the human body is mild. These products do not require pre-market approval but are subject to a notification process prior to marketing.
Quasi-drugs (Medicated Products / Iyakubuhaihin): Products that have a specific efficacy, exert a mild action on the human body, and fall squarely between pharmaceuticals and cosmetics. They must contain active ingredients approved by the MHLW and can claim specific benefits. These products are subject to a strict pre-market approval process, which includes a comprehensive assessment of product safety, efficacy, and quality.
Notification/Registration Process
Main Compliance Process for Cosmetics
Main Compliance Process for Quasi-Drugs (Pseudo-pharmaceuticals)
Required Documentation
Cosmetics Notification
- Manufacturer Notification (Filing): Application form, proof of manufacturing qualifications, basic company information, etc.
- Marketing License: The primary marketing license (Seizo-hanbai-gyo) held by the local Japanese representative.
- Manufacturer Information: Details regarding the manufacturing facility.
- Product Information: Including but not limited to product name, ingredient names, purpose of use and concentrations, Japanese-compliant label text, and packaging artwork/diagrams.
Quasi-Drug Registration
- Manufacturer Registration: Including but not limited to the application form, an overview of the manufacturing facility's equipment and structure, factory blueprints, building layouts, and official documents proving manufacturing and business qualifications.
- Marketing License: The primary marketing license (Seizo-hanbai-gyo) held by the local Japanese representative.
- Origin and Development History: Documentation on the country of origin, the product development process, and its history of use overseas.
- Physicochemical Properties, Specifications, and Testing Methods: Detailed data regarding the physical and chemical properties, product specifications, and analytical testing methods for both the finished product and its active ingredients.
- Stability Data: Documentation demonstrating the product's stability under various conditions over time.
- Safety Data: Comprehensive toxicological and safety evaluation data.
- Efficacy Validation Data: Scientific data and clinical/laboratory evidence supporting the claimed benefits and efficacy.
- Exemptions for Items 3 to 7: Depending on the risk classification and category of the quasi-drug, requirements for items 3 through 7 may be reduced or exempted.
Why Choose Us
Navigate Japan’s high-barrier market with expert guidance and flexible compliance solutions.
Comprehensive Solutions
Regulatory solutions to ensure your cosmetic products are fully compliant and ready for the Japan market.
Expert guidance for general cosmetics notification and quasi-drug registration in compliance with MHLW and PMDA requirements.
Review formulations against Japan’s Cosmetic Standards and Quasi-Drug Ingredient Standards to ensure compliance.
Determine whether the product is a cosmetic or quasi-drug and interpret applicable Japanese regulations.
Provide support for quality systems, adverse event reporting, and product recall management.
Support preparation and submission of technical documentation, including safety, stability, and efficacy data (for quasi-drugs).
Ensure labels meet Japanese requirements and claims align with approved scope and advertising rules.
Frequently Asked Questions
What is the first step before entering the Japanese market?
Determine whether the product is a cosmetic or quasi-drug, as the regulatory pathways differ significantly.
Who can act as the responsible entity in Japan?
A licensed Marketing Authorization Holder must be established under the supervision of the Ministry of Health, Labour and Welfare (MHLW).
Is notification required for cosmetics in Japan?
Yes. Both manufacturer notification (via PMDA) and product notification (to local authorities) must be completed before sale.
Do quasi-drugs require approval?
Yes. Quasi-drugs must obtain pre-market approval, which may include GMP inspection and technical review.
What are common compliance risks?
Key risks include incorrect classification, non-compliant ingredients, unsupported claims, and missing licenses or GMP compliance.