Market Authorization & Cosmetic Registration in Japan

Market Authorization & Cosmetic Registration in Japan

Cosmetic Product Registration in Japan: Understanding the MAH Requirement

Cosmetic products in Japan are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Devices (PMD) Act. The MHLW ensures that all cosmetics in the Japanese market comply with strict regulations covering ingredients, safety, labeling, and marketing claims.

What is a Marketing Authorization Holder (MAH)?

To legally manufacture or import cosmetics into Japan, businesses must obtain a Marketing Authorization Holder (MAH) license. The MAH is a locally-based entity or an appointed representative responsible for regulatory compliance. Without an MAH, foreign companies cannot legally enter the Japanese cosmetics market.

Why is an MAH Required in Japan?

The MAH plays a critical role in ensuring product safety and compliance, acting as the official liaison between the manufacturer/importer and Japanese authorities.

Key Responsibilities of an MAH:

• Responds to all queries, remarks, or requests from the Health Authority (HA).
• Serves as the primary Point of Contact between the brand and MHLW/PMDA.
• Monitors and reports any adverse reactions to ensure consumer safety.
• Advises on necessary corrective actions in the event of safety incidents.
• Provides local language support for regulatory communications.
• Verifies that all ingredients and labels conform to Japanese regulations.
• Keeps you updated on regulatory labeling or submission changes.
• Assists in navigating the right regulatory pathways and documentation.

Key Challenges in Japan’s Cosmetic Registration

Japan’s regulatory environment for cosmetics is one of the most sophisticated and strict globally. Common challenges include:

• Misleading Claims: Unsubstantiated product claims (e.g., “clinically proven”) may lead to product rejection or fines.
• Quasi-Drug Classification: Products with functions such as skin whitening, anti-dandruff, or UV protection may be classified as quasi-drugs, requiring pre-market approval.
• Ingredient Listing Errors: Incorrect or incomplete ingredient disclosures can delay approvals.
• Labeling Errors: All cosmetic labels must be in Japanese—poor translations are a frequent compliance issue.
• Mandatory MAH Appointment: Without a local MAH, no notification or market entry is allowed.
• Prohibited Claims: Phrases like “doctor recommended” are banned unless cleared by MHLW.

Your Partner in Japanese Cosmetic Compliance

With growing demand for cosmetic products in Japan, navigating the regulatory landscape requires expert guidance. At Freyr, we help companies every step of the way—from securing MAH support to ensuring regulatory submissions, product classification, labeling, and compliance monitoring are flawlessly executed.

Looking to Launch Cosmetics in Japan?

Freyr's regulatory experts are here to ensure your products meet Japan’s highest standards of quality and safety.

Contact Freyr Today to get started on your Japan cosmetics market entry journey.